^(1){ }^{1} ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense of Madrid, Madrid, Spain ^(1){ }^{1} 馬德里康普頓斯大學牙周與植體疾病病因及治療(ETEP)研究組,西班牙馬德里 ^(2){ }^{2} Periodontal Research Group, Institute of Clinical Sciences, College of Medical and Dental Sciences, The University of Birmingham, Birmingham, UK ^(2){ }^{2} 伯明罕大學醫學與牙科學院臨床科學研究所牙周研究組,英國伯明罕 ^(3){ }^{3} Birmingham Community Healthcare NHS Trust, Birmingham, UK ^(3){ }^{3} 英國伯明罕社區醫療保健國民保健信託 ^(4){ }^{4} Division of Periodontics, Section of Oral, Diagnostic and Rehabilitation Sciences, College of Dental Medicine, Columbia University, New York, NY, USA ^(4){ }^{4} 美國紐約哥倫比亞大學牙醫學院口腔診斷與復健科學系牙周病學科 ^(5){ }^{5} Department of Periodontology, Operative and Preventive Dentistry, University Hospital Bonn, Bonn, Germany ^(5){ }^{5} 德國波恩大學醫院牙周病學、修復與預防牙醫學系 ^(6){ }^{6} Department of Periodontology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden ^(6){ }^{6} 瑞典哥德堡大學薩爾格學院牙科研究所牙周病學系 ^(7){ }^{7} Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland ^(7){ }^{7} 瑞士伯恩大學牙醫學院牙周病學系 ^(8){ }^{8} Division of Periodontology and Implant Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong, Hong Kong ^(8){ }^{8} 香港大學牙醫學院牙周病學與植牙學部 ^(9){ }^{9} Department of Oral and Maxillo-facial Implantology, Shanghai Key Laboratory of Stomatology, National Clinical Research Centre for Stomatology, Shanghai Ninth People Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China ^(9){ }^{9} 中國上海交通大學醫學院附屬第九人民醫院口腔顎面植牙學系,上海市口腔醫學重點實驗室,國家口腔疾病臨床醫學研究中心
Correspondence 通訊作者
Mariano Sanz, ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group Faculty of Odontology, University Complutense of Madrid, Plaza Ramón y Cajal s/n (Ciudad Universitaria), 馬里亞諾·桑茲,馬德里康普頓斯大學牙科學院 ETEP(牙周及植體周圍疾病病因與治療)研究小組,拉蒙·卡哈爾廣場 s/n(大學城)
Periodontitis is characterized by progressive destruction of the tooth-supporting apparatus. Its primary features include the loss of periodontal tissue support manifest through clinical attachment loss (CAL) and radiographically assessed alveolar bone loss, presence of periodontal pocketing and gingival bleeding (Papapanou et al., 2018). If untreated, it may lead to tooth loss, although it is preventable and treatable in the majority of cases. 牙周炎的特徵是牙齒支持組織的進行性破壞。其主要表現包括牙周組織支持的喪失,臨床上可觀察到附連喪失(CAL)和透過 X 光評估的齒槽骨流失,並伴隨牙周囊袋形成與牙齦出血(Papapanou 等人,2018)。若未經治療,可能導致牙齒脫落,但在多數情況下是可預防且可治療的。
1.1.2 | Importance 1.1.2 | 重要性
Periodontitis is a major public health problem due to its high prevalence, and since it may lead to tooth loss and disability, it negatively affects chewing function and aesthetics, is a source of social inequality, and significantly impairs quality of life. Periodontitis accounts for a substantial proportion of edentulism and masticatory dysfunction, has a negative impact on general health and results in significant dental care costs (Tonetti, Jepsen, Jin, & Otomo-Corgel, 2017). 牙周炎因其高盛行率而成為重大公共衛生問題,且可能導致牙齒脫落與功能障礙,對咀嚼功能與美觀造成負面影響,成為社會不平等的來源,並顯著降低生活品質。牙周炎佔無牙症與咀嚼功能障礙的相當比例,對全身健康有負面影響,並導致龐大牙科照護成本(Tonetti、Jepsen、Jin 與 Otomo-Corgel,2017)。
1.1.3 | Pathophysiology 1.1.3 | 病理生理學
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic dental plaque biofilms. 牙周炎是一種與菌群失調的牙菌斑生物膜相關的慢性多因素發炎性疾病。
1.1.4 | Prevalence 1.1.4 | 盛行率
Periodontitis is the most common chronic inflammatory non-communicable disease of humans. According to the Global Burden of Disease 2010 study, the global age-standardized prevalence (1990-2010) of severe periodontitis was 11.2%11.2 \%, representing the sixth-most prevalent condition in the world (Kassebaum et al., 2014), while in the Global Burden of Disease 2015 study, the prevalence of severe periodontitis was estimated in 7.4%7.4 \% (Kassebaum et al., 2017). The prevalence of milder forms of periodontitis may be as high as 50% (Billings et al., 2018). 牙周炎是人類最常見的慢性發炎性非傳染性疾病。根據 2010 年全球疾病負擔研究,嚴重牙周炎的全球年齡標準化盛行率(1990-2010 年)為 11.2%11.2 \% ,使其成為全球第六大盛行疾病(Kassebaum 等人,2014 年);而在 2015 年全球疾病負擔研究中,嚴重牙周炎的盛行率估計為 7.4%7.4 \% (Kassebaum 等人,2017 年)。較輕微形式的牙周炎盛行率可能高達 50%(Billings 等人,2018 年)。
1.1.5 | Consequences of failure to treat 1.1.5 | 未接受治療的後果
Untreated or inadequately treated periodontitis leads to the loss of tooth-supporting tissues and teeth. Severe periodontitis, along with 未經治療或治療不當的牙周炎會導致牙齒支持組織和牙齒的喪失。嚴重牙周炎,連同
Clinical Relevance 臨床相關性
Scientific rationale for the study: Implementation of the new classification of periodontitis should facilitate the use of the most appropriate preventive and therapeutic interventions, depending on the stage and grade of the disease. The choice of these interventions should be made following a rigorous evidence-based decision-making process. 研究科學依據:實施新的牙周炎分類應有助於根據疾病的階段和等級,採用最適當的預防和治療干預措施。這些干預措施的選擇應遵循嚴格的循證決策過程。
Principal findings: This guideline has been developed using strict validated methodologies for assuring the best available evidence on the efficacy of the interventions considered and the most appropriate recommendations based on a structured consensus process, including a panel of experts and representatives from key stakeholders. 主要發現:本指南是使用嚴格驗證的方法開發的,以確保所考慮干預措施的最佳可用證據,並基於結構化共識過程(包括專家小組和關鍵利益相關者代表)提出最適當的建議。
Practical implications: The application of this S3 Level Clinical Practice Guideline will allow a homogeneous and evidence-based approach to the management of Stage I-III periodontitis. 實際應用:這份 S3 級臨床實踐指南的應用,將能為第一至第三期牙周炎的治療提供一致且基於實證的處理方式。
dental caries, is responsible for more years lost to disability than any other human disease (GBD 2017 Disease and Injury Incidence and Prevalence Collaborators, 2018). Furthermore, periodontal infections are associated with a range of systemic diseases leading to premature death, including diabetes (Sanz et al., 2018), cardiovascular diseases (Sanz et al., 2019; Tonetti, Van Dyke, & Working Group 1 of the Joint EFP/AAP Workshop, 2013) or adverse pregnancy outcomes (Sanz, Kornman, & Working Group 3 of Joint EFP/AAP Workshop, 2013). 齲齒所導致的失能年數,比任何人類疾病都來得多(GBD 2017 疾病與傷害發生率及盛行率合作組織,2018)。此外,牙周感染與多種導致早逝的全身性疾病有關,包括糖尿病(Sanz 等人,2018)、心血管疾病(Sanz 等人,2019;Tonetti、Van Dyke 及 EFP/AAP 聯合研討會第一工作小組,2013)或不良妊娠結果(Sanz、Kornman 及 EFP/AAP 聯合研討會第三工作小組,2013)。
1.1.6 | Economic importance 1.1.6 | 經濟重要性
On a global scale, periodontitis is estimated to cost $54 billion in direct treatment costs and further $25 billion in indirect costs (GBD 2017 Disease and Injury Incidence and Prevalence Collaborators, 2018). Periodontitis contributes significantly to the cost of dental diseases due to the need to replace teeth lost to periodontitis. The total cost of dental diseases, in 2015, was estimated to be of $544.41\$ 544.41 billion, being $356.80\$ 356.80 billion direct costs, and $187.61\$ 187.61 billion indirect costs (Righolt, Jevdjevic, Marcenes, & Listl, 2018). 在全球範圍內,牙周炎的治療直接成本估計達 540 億美元,間接成本更高達 250 億美元(GBD 2017 疾病與傷害發生率及盛行率合作組織,2018)。由於需要替換因牙周炎而喪失的牙齒,牙周炎對牙科疾病總成本造成顯著影響。2015 年牙科疾病總成本估計達 $544.41\$ 544.41 億美元,其中 $356.80\$ 356.80 億為直接成本, $187.61\$ 187.61 億為間接成本(Righolt, Jevdjevic, Marcenes, & Listl, 2018)。
2 | AIM OF THE GUIDELINE 2 | 臨床指引目標
This guideline aims to highlight the importance and need for scientific evidence in clinical decision-making in the treatment of patients 本指引旨在強調科學證據在患者治療臨床決策中的重要性與必要性
with periodontitis stages I to III. Its main objective is therefore to support the evidence-based recommendations for the different interventions used at the different steps of periodontal therapy, based on the best available evidence and/or expert consensus. In so doing, this guideline aims to improve the overall quality of periodontal treatment in Europe, reduce tooth loss associated with periodontitis and ultimately improve overall systemic health and quality of life. A separate guideline covering the treatment of Stage IV periodontitis will be published. 針對第一至第三期牙周炎患者。其主要目標是根據現有最佳證據和/或專家共識,支持針對牙周治療各階段不同介入措施的實證建議。透過此指引,旨在提升歐洲牙周治療整體品質,減少牙周炎相關牙齒缺失,最終改善全身健康與生活品質。針對第四期牙周炎的治療指引將另行發布。
2.1 | Target users of the guideline 2.1 | 指引適用對象
Dental and medical professionals, together with all stakeholders related to health care, particularly oral health, including patients. 牙科與醫療專業人員,以及所有與醫療照護相關的利害關係人,特別是口腔健康領域,包括病患在內。
2.2 | Targeted environments 2.2 | 目標環境
Dental and medical academic/hospital environments, clinics and practices. 牙科與醫療學術/醫院環境、診所及診療機構。
2.3 | Targeted patient population 2.3 | 目標患者族群
People with periodontitis stages I to III. 第一至第三期牙周炎患者
People with periodontitis stages I to III following successful treatment. 成功接受治療後的 I 至 III 期牙周炎患者
2.4 | Exceptions from the guideline 2.4 | 本指南的例外情況
This guideline did not consider the health economic cost-benefit ratio, since (a) it covers multiple different countries with disparate, not readily comparable health systems, and (b) there is a paucity of sound scientific evidence available addressing this question. This guideline did not consider the treatment of gingivitis (although management of gingivitis is considered as an indirect goal in some interventions evaluated), the treatment of Stage IV periodontitis, necrotising periodontitis, periodontitis as manifestation of systemic diseases and mucogingival conditions. 本指南未考量健康經濟成本效益比,原因在於:(a) 其涵蓋多個不同國家,這些國家的醫療體系差異大且難以直接比較;(b) 目前缺乏針對此問題的可靠科學證據。本指南未涵蓋牙齦炎的治療(儘管在某些評估的介入措施中,牙齦炎管理被視為間接目標)、第四期牙周炎治療、壞死性牙周炎、作為全身性疾病表現的牙周炎,以及黏膜牙齦狀況。
3 | METHODOLOGY 3 | 方法論
3.1 | General framework 3.1 | 整體架構
This guideline was developed following methodological guidance published by the Standing Guideline Commission of the Association of Scientific Medical Societies in Germany (AWMF) (https://www. awmf.org/leitlinien/awmf-regelwerk/awmf-guidance.html) and the Grading of Recommendations Assessment, Development and 本指南是依據德國科學醫學學會聯盟(AWMF)常設指南委員會(網址:https://www.awmf.org/leitlinien/awmf-regelwerk/awmf-guidance.html)以及建議評量、發展與
Evaluation (GRADE) Working Group (https://www.gradeworkinggroup.org/). 評估(GRADE)工作小組(網址:https://www.gradeworkinggroup.org/)所發布的方法學指引所制定。
The guideline was developed under the auspices of the European Federation of Periodontology (EFP) and overseen by the EFP Workshop Committee. This guideline development process was steered by an Organizing Committee and a group of methodology consultants designated by the EFP. All members of the Organizing Committee were part of the EFP Workshop Committee. 本指南在歐洲牙周病學聯盟(EFP)的主導下制定,並由 EFP 研討會委員會監督。整個指南制定過程由 EFP 指定的組織委員會和方法學顧問團隊共同指導。組織委員會的所有成員均為 EFP 研討會委員會的成員。
To ensure adequate stakeholder involvement, the EFP established a guideline panel involving dental professionals representing 36 national periodontal societies within the EFP (Table 1a). 為確保充分納入相關利益者的參與,歐洲牙周病學會(EFP)成立了一個由代表 EFP 內 36 個國家牙周病學會的牙科專業人士組成的指南制定小組(表 1a)。
These delegates were nominated, participated in the guideline development process and had voting rights in the consensus conference. For the guideline development process, delegates were assigned to four Working Groups that were chaired by the members of the Organizing Committee and advised by the methodology consultants. This panel was supported by key stakeholders from European scientific societies with a strong professional interest in periodontal care and from European organizations representing key groups within the dental profession, and key experts from non-EFP member countries, such as North America (Table 1b). 這些代表經提名參與指南制定流程,並在共識會議中擁有投票權。在指南制定過程中,代表們被分配到四個工作小組,由組織委員會成員擔任主席,並由方法學顧問提供建議。此小組還獲得來自歐洲科學學會(對牙周照護具有強烈專業興趣)、代表牙科專業關鍵群體的歐洲組織,以及非 EFP 成員國(如北美)關鍵專家的支持(表 1b)。
In addition, EFP engaged an independent guideline methodologist to advise the panel and facilitate the consensus process (Prof. Dr. med. Ina Kopp). The guideline methodologist had no voting rights. 此外,EFP 聘請了獨立的指南方法學專家(Ina Kopp 醫學教授)為小組提供建議並促進共識流程。該方法學專家不具投票權。
EFP and the guideline panel tried to involve patient organizations but were not able to identify any regarding periodontal diseases at European level. In a future update, efforts will be undertaken to include the perspective of citizens/patients (Brocklehurst et al., 2018). EFP 與指南小組曾嘗試納入患者組織參與,但未能找到歐洲層級針對牙周疾病的相關組織。在未來的更新版本中,將致力納入公民/患者的觀點(Brocklehurst 等人,2018 年)。
3.2 | Evidence synthesis 3.2 | 證據綜整
3.2.1 | Systematic search and critical appraisal of guidelines 3.2.1 | 系統性文獻檢索與指南評析
To assess and utilize existing guidelines during the development of the present guideline, well-established guideline registers and the websites of large periodontal societies were electronically searched for potentially applicable guideline texts: 為在本指南制定過程中評估並運用現有指南,我們透過電子檢索已建立的指南註冊系統及大型牙周病學會網站,尋找可能適用的指南文本:
The National Institute for Health and Clinical Excellence (NICE) 國家健康與臨床卓越研究院 (NICE)
Canadian Health Technology Assessment (CADTH) 加拿大衛生技術評估局 (CADTH)
European Federation for Periodontology (EFP) 歐洲牙周病學聯盟 (EFP)
American Academy of Periodontology (AAP) 美國牙周病學會 (AAP)
American Dental Association (ADA) 美國牙科協會 (ADA)
The last search was performed on 30 September 2019. Search terms used were “periodont*,” “Periodontal,” “Guidelines” and “Clinical Practice Guidelines.” In addition, content was screened by hand searches. See Table 2. 最後一次文獻搜尋於 2019 年 9 月 30 日執行。使用的搜尋關鍵詞包括「牙周病*」、「牙周」、「指南」和「臨床實踐指南」。此外,還透過人工篩選方式審查內容。詳見表 2。
Council of European Chief Dental Officers 歐洲首席牙醫官理事會
Kenneth Eaton 肯尼斯·伊頓
"Scientific society/ organization
Delegate(s)"
European Tord Berglundh, Iain Chapple, David Herrera, Søren Jepsen, Moritz Kebschull, Mariano Sanz, Anton Sculean, Maurizio Tonetti
Ina Kopp, Paul Brocklehurst, Jan Wennström
Clinical Experts:
Anne Merete Aass, Mario Aimetti, Georgios
Belibasakis, Juan Blanco, Nagihan Bostanci,
Jan Cosyn, Francesco D'Aiuto, Bettina
Dannewitz, Monique Danser, Korkud
Thomas Dietrich, Christof Dörfer, Henrik
Dommisch, Nikos Donos, Peter Eickholz,
Goldstein, Filippo Graziani, Thomas Kocher,
Molina, Eduardo Montero, José Nart, Ian
Needleman, Luigi Nibali, Panos Papapanou,
Andrea Pilloni, David Polak, Ioannis
Christoph Ramseier, Stefan Renvert,
Stavropoulos, Xavier Struillou, Jean Suvan,
Wim Teughels, Cristiano Tomasi, Leonardo
Trombelli, Fridus van der Weijden, Clemens
Walter, Nicola West, Gernot Wimmer
Scientific Societies
European Society for Endodontology Lise Lotte Kirkevang
European Prosthodontic Association Phophi Kamposiora
European Paula Vassallo
Association of Dental Public
Health
European Laura Ceballos
Other organisations
Council of European Chief Dental Officers Kenneth Eaton| Scientific society/ organization <br> Delegate(s) | |
| :--- | :--- |
| European | Tord Berglundh, Iain Chapple, David Herrera, Søren Jepsen, Moritz Kebschull, Mariano Sanz, Anton Sculean, Maurizio Tonetti |
| | Ina Kopp, Paul Brocklehurst, Jan Wennström |
| | Clinical Experts: |
| | Anne Merete Aass, Mario Aimetti, Georgios |
| | Belibasakis, Juan Blanco, Nagihan Bostanci, |
| | Jan Cosyn, Francesco D'Aiuto, Bettina |
| | Dannewitz, Monique Danser, Korkud |
| | Thomas Dietrich, Christof Dörfer, Henrik |
| | Dommisch, Nikos Donos, Peter Eickholz, |
| | Goldstein, Filippo Graziani, Thomas Kocher, |
| | Molina, Eduardo Montero, José Nart, Ian |
| | Needleman, Luigi Nibali, Panos Papapanou, |
| | Andrea Pilloni, David Polak, Ioannis |
| | Christoph Ramseier, Stefan Renvert, |
| | Stavropoulos, Xavier Struillou, Jean Suvan, |
| | Wim Teughels, Cristiano Tomasi, Leonardo |
| | Trombelli, Fridus van der Weijden, Clemens |
| | Walter, Nicola West, Gernot Wimmer |
| Scientific Societies | |
| European Society for Endodontology | Lise Lotte Kirkevang |
| European Prosthodontic Association | Phophi Kamposiora |
| European | Paula Vassallo |
| Association of Dental Public | |
| Health | |
| European | Laura Ceballos |
| Other organisations | |
| Council of European Chief Dental Officers | Kenneth Eaton |
TABLE 1 A (Continued) 表 1 A(續)
Scientific society/ organization 科學學會/組織
Delegate(s) 代表人員
Council of European Dentists 歐洲牙醫理事會
Paulo Melo 保羅·梅洛
European Dental Hygienists' Federation 歐洲牙科衛生師聯合會
Ellen Bol-van den Hil 艾倫·波爾-范登希爾
European Dental Students' Association 歐洲牙科學生協會
Daniela Timus 丹妮拉·提姆斯
Platform for Better Oral Health in Europe 歐洲口腔健康促進平台
Kenneth Eaton 肯尼斯·伊頓
Scientific society/ organization Delegate(s)
Council of European Dentists Paulo Melo
European Dental Hygienists' Federation Ellen Bol-van den Hil
European Dental Students' Association Daniela Timus
Platform for Better Oral Health in Europe Kenneth Eaton| Scientific society/ organization | Delegate(s) |
| :--- | :--- |
| Council of European Dentists | Paulo Melo |
| European Dental Hygienists' Federation | Ellen Bol-van den Hil |
| European Dental Students' Association | Daniela Timus |
| Platform for Better Oral Health in Europe | Kenneth Eaton |
Only guidelines published in English and with full texts available were included. The methodological quality of these guideline texts was critically appraised using the AGREE II framework (https:// www.agreetrust.org/agree-ii/). 僅納入以英文發表且全文可取得之指引。這些指引文本的方法學品質採用 AGREE II 架構(https://www.agreetrust.org/agree-ii/)進行嚴格評估。
3.2.2 | Systematic search and critical appraisal of the literature 3.2.2 | 文獻系統性搜尋與批判性評估
For this guideline, a total of 15 systematic reviews (SRs) were conducted to support the guideline development process (Carra et al., 2020; Dommisch, Walter, Dannewitz, & Eickholz, 2020; Donos et al., 2019; Figuero, Roldan, et al., 2019; Herrera et al., 2020; Jepsen et al., 2019; Nibali et al., 2019; Polak et al., 2020; Ramseier et al., 2020; Salvi et al., 2019; Sanz-Sanchez et al., 2020; Slot, Valkenburg, & van der Weijden, 2020; Suvan et al., 2019; Teughels et al., 2020; Trombelli et al., 2020). The corresponding manuscripts are published within this special issue of the Journal of Clinical Periodontology. 本臨床指引共進行了 15 篇系統性文獻回顧(SRs)以支持指引制定流程(Carra 等人,2020;Dommisch、Walter、Dannewitz 與 Eickholz,2020;Donos 等人,2019;Figuero、Roldan 等人,2019;Herrera 等人,2020;Jepsen 等人,2019;Nibali 等人,2019;Polak 等人,2020;Ramseier 等人,2020;Salvi 等人,2019;Sanz-Sanchez 等人,2020;Slot、Valkenburg 與 van der Weijden,2020;Suvan 等人,2019;Teughels 等人,2020;Trombelli 等人,2020)。相關論文均發表於《臨床牙周病學期刊》本期特刊中。
All SRs were conducted following the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) framework (Moher, Liberati, Tetzlaff, & Altman, 2009). 所有系統性文獻回顧均遵循「系統性文獻回顧與統合分析優先報告項目」(PRISMA)框架進行(Moher、Liberati、Tetzlaff 與 Altman,2009)。
3.2.3 | Focused questions 3.2.3 | 聚焦問題
In all 15 systematic reviews, focused questions in PICO(S)\mathrm{PICO}(\mathrm{S}) format (Guyatt et al., 2011) were proposed by the authors in January 2019 to a panel comprising the working group chairs and the methodological consultants, in order to review and approve them (Table 3). The panel took great care to avoid overlaps or significant gaps between the SRs, so they would truly cover all possible interventions currently undertaken in periodontal therapy. 在所有 15 篇系統性文獻回顧中,作者們於 2019 年 1 月以 PICO(S)\mathrm{PICO}(\mathrm{S}) 格式(Guyatt 等人,2011 年)提出聚焦問題,交由工作組主席和方法學顧問組成的專家小組審查核准(表 3)。該小組特別注意避免各系統性回顧之間出現重疊或重大遺漏,以確保這些回顧能真正涵蓋目前牙周治療中所有可能的介入措施。
Association for Dental Education in Europe 歐洲牙科教育協會
ADEE
No answer 無回應
No representative 無代表
Council of European Chief Dental Officers 歐洲首席牙醫官理事會
CECDO
Participant 參與者
Ken Eaton/ Paula Vassallo 肯·伊頓/寶拉·瓦薩洛
Council of European Dentists 歐洲牙醫理事會
CED
Participant 參與者
Paulo Melo 保羅·梅洛
European Association of Dental Public Health 歐洲牙科公共衛生協會
EADPH
Participant 參與者
Paula Vassallo 寶拉·瓦薩洛
European Dental Hygienists Federation 歐洲牙科衛生師聯合會
EDHF
Participant 參與者
Ellen Bol-van den Hil 艾倫·波爾-范登希爾
European Dental Students' Association 歐洲牙科學生協會
EDSA
Participant 參與者
Daniella Timus 丹妮拉·提姆斯
European Federation of Conservative Dentistry 歐洲保守牙科聯合會
EFCD
Participant 參與者
Laura Ceballos 蘿拉·塞巴洛斯
European Orthodontic Society 歐洲矯正學會
EOS
No answer 未回應
No representative 無代表
European Prosthodontic Association 歐洲義齒修復學會
EPA
Participant 參與者
Phophi Kamposiora 福菲·坎波西奧拉
European Society of Endodontology 歐洲牙髓病學會
ESE
Participant 參與者
Lise Lotte Kirkevang 莉絲·洛特·柯克凡
Platform for Better Oral Health in Europe 歐洲口腔健康促進平台
PBOHE
Participant 參與者
Kenneth Eaton 肯尼斯·伊頓
Institution Acronym Answer ^("a ") Representative
Association for Dental Education in Europe ADEE No answer No representative
Council of European Chief Dental Officers CECDO Participant Ken Eaton/ Paula Vassallo
Council of European Dentists CED Participant Paulo Melo
European Association of Dental Public Health EADPH Participant Paula Vassallo
European Dental Hygienists Federation EDHF Participant Ellen Bol-van den Hil
European Dental Students' Association EDSA Participant Daniella Timus
European Federation of Conservative Dentistry EFCD Participant Laura Ceballos
European Orthodontic Society EOS No answer No representative
European Prosthodontic Association EPA Participant Phophi Kamposiora
European Society of Endodontology ESE Participant Lise Lotte Kirkevang
Platform for Better Oral Health in Europe PBOHE Participant Kenneth Eaton| Institution | Acronym | Answer ${ }^{\text {a }}$ | Representative |
| :--- | :--- | :--- | :--- |
| Association for Dental Education in Europe | ADEE | No answer | No representative |
| Council of European Chief Dental Officers | CECDO | Participant | Ken Eaton/ Paula Vassallo |
| Council of European Dentists | CED | Participant | Paulo Melo |
| European Association of Dental Public Health | EADPH | Participant | Paula Vassallo |
| European Dental Hygienists Federation | EDHF | Participant | Ellen Bol-van den Hil |
| European Dental Students' Association | EDSA | Participant | Daniella Timus |
| European Federation of Conservative Dentistry | EFCD | Participant | Laura Ceballos |
| European Orthodontic Society | EOS | No answer | No representative |
| European Prosthodontic Association | EPA | Participant | Phophi Kamposiora |
| European Society of Endodontology | ESE | Participant | Lise Lotte Kirkevang |
| Platform for Better Oral Health in Europe | PBOHE | Participant | Kenneth Eaton |
ªMessages sent 20 March 2019; reminder sent June 18. ª訊息發送於 2019 年 3 月 20 日;提醒信於 6 月 18 日寄出。
TABLE 1B Key stakeholders contacted and participants 表 1B 主要利害關係人聯繫與參與者名單
3.2.4 | Relevance of outcomes 3.2.4 | 結果相關性
A narrative review paper was commissioned for this guideline (Loos & Needleman, 2020) to evaluate the possible outcome measures utilized to evaluate the efficacy of periodontal therapy in relation to true patient-centred outcomes like tooth retention/loss. The authors found that the commonly reported outcome variable with the best demonstrated predictive potential for tooth loss was the reduction in periodontal probing pocket depth (PPD). Therefore, for this guideline, PPD reduction was used as primary outcome for those systematic reviews not addressing periodontal regeneration, and where tooth survival data were not reported. When reviewing regenerative interventions, gains in clinical attachment were used as the primary outcome measure. To avoid introducing bias by including possibly spurious findings of studies with very short follow-up, a minimal follow-up period of six months was requested for all reviews. 本臨床指引委託撰寫了一篇敘述性回顧論文(Loos & Needleman, 2020),旨在評估用於衡量牙周治療效果的可能結果指標,特別是與患者真正關切的結果(如牙齒保留/喪失)相關的指標。作者發現,在常見報告的結果變量中,最能有效預測牙齒喪失的是牙周探測囊袋深度(PPD)的減少。因此,在本指引中,對於那些未涉及牙周再生且未報告牙齒存活數據的系統性回顧,將 PPD 減少作為主要結果指標。在評估再生性介入措施時,則以臨床附著增益作為主要結果指標。為避免納入追蹤期過短研究可能產生的虛假結果而造成偏差,所有回顧研究均要求至少六個月的最低追蹤期。
3.2.5 | Search strategy 3.2.5 | 文獻檢索策略
All SRs utilized a comprehensive search strategy of at least two different databases, supplemented by a hand search of periodontal journals and the reference lists of included studies. 所有系統性回顧均採用至少兩種不同數據庫的全面檢索策略,並輔以手工檢索牙周病學期刊及納入研究的參考文獻列表。
In all SRs, the electronic and manual search, as well as the data extraction, was done in parallel by two different investigators. 在所有系統性回顧中,電子與人工檢索以及數據提取均由兩位不同的研究人員同步進行。
3.2.6 | Quality assessment of included studies 3.2.6 | 納入研究之品質評估
In all SRs, the risk of bias of controlled clinical trials was assessed using the Cochrane risk of bias tool (https://methods.cochrane.org/ bias/resources/rob-2-revised-cochrane-risk-bias-tool-randomized 所有系統性回顧中,對照臨床試驗的偏誤風險皆採用 Cochrane 偏誤風險工具進行評估( https://methods.cochrane.org/ bias/resources/rob-2-revised-cochrane-risk-bias-tool-randomized
-trials). For observational studies, the Newcastle-Ottawa Scale was used http://www.ohri.ca/programs/clinical_epidemiology/oxford. asp. -trials)。觀察性研究則採用紐卡斯爾-渥太華量表 http://www.ohri.ca/programs/clinical_epidemiology/oxford. asp。
3.2.7 | Data synthesis 3.2.7 | 資料綜合
Where applicable, the available evidence was summarized by means of meta-analysis, or other tools aimed for pooling data (network meta-analysis, Bayesian network meta-analysis). 在適用的情況下,可用的證據透過統合分析或其他旨在彙整資料的工具(網絡統合分析、貝葉斯網絡統合分析)進行總結。
3.3 | From evidence to recommendation: structured consensus process 3.3 | 從證據到建議:結構化共識流程
The structured consensus development conference was held during the XVI European Workshop in Periodontology in La Granja de San Ildefonso Segovia, Spain, on 10-13 November 2019. Using the 15 SRs as background information, evidence-based recommendations were formally debated by the guideline panel using the format of a structured consensus development conference, consisting of small group discussions and open plenary were the proposed recommendations were presented, voted and adopted by consensus and Murphy et al. (1998). 結構化共識發展會議於 2019 年 11 月 10 日至 13 日在西班牙塞哥維亞的 La Granja de San Ildefonso 舉行的第十六屆歐洲牙周病學研討會期間召開。以 15 份系統性回顧作為背景資訊,指南小組採用結構化共識發展會議的形式正式討論了基於證據的建議,該會議包括小組討論和公開全體會議,在會議中提出的建議經過展示、投票並以共識方式通過,參考 Murphy 等人(1998 年)的方法。
Guideline International Network (GIN) International Guidelines Library ^("a "){ }^{\text {a }} Guideline International Network (GIN) 國際指南資料庫 ^("a "){ }^{\text {a }}
Comprehensive periodontal therapy: a statement by the American Academy of Periodontology. American Academy of Periodontology. NGC:008726 (2011) 全面性牙周治療:美國牙周病學會聲明。美國牙周病學會。NGC:008726 (2011)
8 years old, recommendations not based on systematic evaluation of evidence, not applicable 8 年歷史,建議非基於系統性證據評估,不適用
DG PARO S3 guideline (Register Number 083-029)Adjuvant systemic administration of antibiotics for subgingival instrumentation in the context of systematic periodontitis treatment (2018) DG PARO S3 指南(註冊號 083-029)系統性牙周炎治療中輔助性全身抗生素給藥用於齦下器械治療 (2018)
Very recent, high methodological standard, very similar outcome measures - relevant 非常近期、高方法學標準、非常相似的結果測量——相關
HealthPartners Dental Group and Clinics guidelines for the diagnosis and treatment of periodontal diseases. HealthPartners Dental Group. NGC:008848 (2011) 健康夥伴牙科集團與診所的牙周疾病診斷與治療指南。健康夥伴牙科集團。NGC:008848 (2011)
8 years old, unclear methodology, not applicable 8 年歷史,方法學不明確,不適用
Health Partners Dental Group and Clinics Caries Guideline 健康夥伴牙科集團與診所齲齒治療指南
Not applicable 不適用
The National Institute for Health and Clinical Excellence (NICE) ^("b "){ }^{\text {b }} 英國國家健康與臨床卓越研究院(NICE) ^("b "){ }^{\text {b }}
No thematically relevant hits 無相關主題結果
Not applicable 不適用
National Guideline Clearinghouse (Agency for Healthcare Research and Quality) ^("c "){ }^{\text {c }} 國家臨床指引資料庫(醫療照護研究與品質局) ^("c "){ }^{\text {c }}
No thematically relevant hits 無相關主題結果
Not applicable 不適用
Canadian Health Technology Assessment (CADTH) ^("d "){ }^{\text {d }} 加拿大醫療技術評估機構(CADTH) ^("d "){ }^{\text {d }}
Periodontal Regenerative Procedures for Patients with Periodontal Disease: A Review of Clinical Effectiveness (2010) 牙周疾病患者之牙周再生治療程序:臨床療效回顧(2010 年)
9-year-old review article, not applicable 9 年回顧文獻,不適用
Treatment of Periodontal Disease: Guidelines and Impact (2010) 牙周病治療:指南與影響(2010 年)
9-year-old review article, not applicable 9 年回顧文獻,不適用
Dental Scaling and Root Planing for Periodontal Health: A Review of the Clinical Effectiveness, Costeffectiveness, and Guidelines (2016) 牙周健康之牙結石刮除與根面整平術:臨床效益、成本效益與指南回顧(2016 年)
Dental Cleaning and Polishing for Oral Health: A Review of the Clinical Effectiveness, Cost-effectiveness and Guidelines (2013) 牙齒清潔與拋光對口腔健康的臨床效果、成本效益及指南回顧(2013 年)
European Federation of Periodontology (EFP) ^(e){ }^{\mathrm{e}} 歐洲牙周病學聯合會(EFP) ^(e){ }^{\mathrm{e}}
No thematically relevant hits 無相關主題結果
Not applicable 不適用
American Academy of Periodontology (AAP) ^("f "){ }^{\text {f }} 美國牙周病學會 (AAP) ^("f "){ }^{\text {f }}
The American Journal of Cardiology and Journal of Periodontology Editors' Consensus: Periodontitis and Atherosclerotic Vascular Disease (2009) 《美國心臟病學雜誌》與《牙周病學雜誌》編輯共識:牙周炎與動脈粥樣硬化血管疾病(2009 年)
Unclear methodology, 10 year-old consensusbased article, only limited clinically applicably recommendations, not applicable 方法學不明確,基於 10 年前共識的文章,僅提供有限臨床應用建議,不適用
Comprehensive Periodontal Therapy: A Statement by the American Academy of Periodontology (2011) 全面性牙周治療:美國牙周病學會聲明(2011 年)
Unclear methodology (follow-up, outcome variables, recommendations, guideline group), almost a decade old, not applicable 方法學不明確(追蹤方式、結果變數、建議事項、指南制定小組),年代已近十年,不適用
Academy Statements on Gingival Curettage (2002), Local Delivery (2006), Risk Assessment (2008), Efficacy of Lasers (2011) 學會關於牙齦刮治術(2002 年)、局部給藥(2006 年)、風險評估(2008 年)、雷射療效(2011 年)之聲明
Unclear methodology, 10-year-old consensus-based article, only limited clinically applicably recommendations, not applicable 方法學不明確,基於十年舊共識之文獻,僅提供有限臨床適用建議,不適用
American Dental Association (ADA) ^("g "){ }^{\text {g }} 美國牙醫協會 (ADA) ^("g "){ }^{\text {g }}
Nonsurgical Treatment of Chronic Periodontitis Guideline (2015) 慢性牙周炎非手術治療指南 (2015)
Outcome variable CAL (not PPD), no minimal follow-up-not applicable 結果變數為臨床附著喪失(CAL) (非牙周囊袋深度 PPD),無最低追蹤要求-不適用
Database Identified, potentially relevant guidelines Critical appraisal
Guideline International Network (GIN) International Guidelines Library ^("a ") Comprehensive periodontal therapy: a statement by the American Academy of Periodontology. American Academy of Periodontology. NGC:008726 (2011) 8 years old, recommendations not based on systematic evaluation of evidence, not applicable
DG PARO S3 guideline (Register Number 083-029)Adjuvant systemic administration of antibiotics for subgingival instrumentation in the context of systematic periodontitis treatment (2018) Very recent, high methodological standard, very similar outcome measures - relevant
HealthPartners Dental Group and Clinics guidelines for the diagnosis and treatment of periodontal diseases. HealthPartners Dental Group. NGC:008848 (2011) 8 years old, unclear methodology, not applicable
www.Guidelinecentral.com "Dentistry" category Health Partners Dental Group and Clinics Caries Guideline Not applicable
The National Institute for Health and Clinical Excellence (NICE) ^("b ") No thematically relevant hits Not applicable
National Guideline Clearinghouse (Agency for Healthcare Research and Quality) ^("c ") No thematically relevant hits Not applicable
Canadian Health Technology Assessment (CADTH) ^("d ") Periodontal Regenerative Procedures for Patients with Periodontal Disease: A Review of Clinical Effectiveness (2010) 9-year-old review article, not applicable
Treatment of Periodontal Disease: Guidelines and Impact (2010) 9-year-old review article, not applicable
Dental Scaling and Root Planing for Periodontal Health: A Review of the Clinical Effectiveness, Costeffectiveness, and Guidelines (2016) Unclear methodology (follow-up, outcome variables, recommendations, guideline group), not applicable
Dental Cleaning and Polishing for Oral Health: A Review of the Clinical Effectiveness, Cost-effectiveness and Guidelines (2013) Unclear methodology (follow-up, outcome variables, recommendations, guideline group), not applicable
European Federation of Periodontology (EFP) ^(e) No thematically relevant hits Not applicable
American Academy of Periodontology (AAP) ^("f ") The American Journal of Cardiology and Journal of Periodontology Editors' Consensus: Periodontitis and Atherosclerotic Vascular Disease (2009) Unclear methodology, 10 year-old consensusbased article, only limited clinically applicably recommendations, not applicable
Comprehensive Periodontal Therapy: A Statement by the American Academy of Periodontology (2011) Unclear methodology (follow-up, outcome variables, recommendations, guideline group), almost a decade old, not applicable
Academy Statements on Gingival Curettage (2002), Local Delivery (2006), Risk Assessment (2008), Efficacy of Lasers (2011) Unclear methodology, 10-year-old consensus-based article, only limited clinically applicably recommendations, not applicable
American Dental Association (ADA) ^("g ") Nonsurgical Treatment of Chronic Periodontitis Guideline (2015) Outcome variable CAL (not PPD), no minimal follow-up-not applicable| Database | Identified, potentially relevant guidelines | Critical appraisal |
| :--- | :--- | :--- |
| Guideline International Network (GIN) International Guidelines Library ${ }^{\text {a }}$ | Comprehensive periodontal therapy: a statement by the American Academy of Periodontology. American Academy of Periodontology. NGC:008726 (2011) | 8 years old, recommendations not based on systematic evaluation of evidence, not applicable |
| | DG PARO S3 guideline (Register Number 083-029)Adjuvant systemic administration of antibiotics for subgingival instrumentation in the context of systematic periodontitis treatment (2018) | Very recent, high methodological standard, very similar outcome measures - relevant |
| | HealthPartners Dental Group and Clinics guidelines for the diagnosis and treatment of periodontal diseases. HealthPartners Dental Group. NGC:008848 (2011) | 8 years old, unclear methodology, not applicable |
| www.Guidelinecentral.com "Dentistry" category | Health Partners Dental Group and Clinics Caries Guideline | Not applicable |
| The National Institute for Health and Clinical Excellence (NICE) ${ }^{\text {b }}$ | No thematically relevant hits | Not applicable |
| National Guideline Clearinghouse (Agency for Healthcare Research and Quality) ${ }^{\text {c }}$ | No thematically relevant hits | Not applicable |
| Canadian Health Technology Assessment (CADTH) ${ }^{\text {d }}$ | Periodontal Regenerative Procedures for Patients with Periodontal Disease: A Review of Clinical Effectiveness (2010) | 9-year-old review article, not applicable |
| | Treatment of Periodontal Disease: Guidelines and Impact (2010) | 9-year-old review article, not applicable |
| | Dental Scaling and Root Planing for Periodontal Health: A Review of the Clinical Effectiveness, Costeffectiveness, and Guidelines (2016) | Unclear methodology (follow-up, outcome variables, recommendations, guideline group), not applicable |
| | Dental Cleaning and Polishing for Oral Health: A Review of the Clinical Effectiveness, Cost-effectiveness and Guidelines (2013) | Unclear methodology (follow-up, outcome variables, recommendations, guideline group), not applicable |
| European Federation of Periodontology (EFP) ${ }^{\mathrm{e}}$ | No thematically relevant hits | Not applicable |
| American Academy of Periodontology (AAP) ${ }^{\text {f }}$ | The American Journal of Cardiology and Journal of Periodontology Editors' Consensus: Periodontitis and Atherosclerotic Vascular Disease (2009) | Unclear methodology, 10 year-old consensusbased article, only limited clinically applicably recommendations, not applicable |
| | Comprehensive Periodontal Therapy: A Statement by the American Academy of Periodontology (2011) | Unclear methodology (follow-up, outcome variables, recommendations, guideline group), almost a decade old, not applicable |
| | Academy Statements on Gingival Curettage (2002), Local Delivery (2006), Risk Assessment (2008), Efficacy of Lasers (2011) | Unclear methodology, 10-year-old consensus-based article, only limited clinically applicably recommendations, not applicable |
| American Dental Association (ADA) ${ }^{\text {g }}$ | Nonsurgical Treatment of Chronic Periodontitis Guideline (2015) | Outcome variable CAL (not PPD), no minimal follow-up-not applicable |
The consensus process was conducted as follows: 共識流程如下進行:
3.3.1 | Plenary 1 3.3.1 | 第一次全體會議
Introduction to guideline methodology (presentation, discussion) by the independent guideline methodologist (I.K.). 由獨立指南方法學家(I.K.)介紹指南方法學(演示與討論)。
3.3.2 | Working group Phase 1 3.3.2 | 第一階段工作小組
Peer evaluation of declarations of interest and management of conflicts. 同儕審查利益聲明與利益衝突管理
Presentation of the evidence (SR results) by group chairs and methodology consultants. 由小組主席與方法學顧問呈現證據(系統性文獻回顧結果)
Invitation of all members of the working group to reflect critically on the quality of available evidence by group chairs, considering GRADE criteria. 小組主席邀請全體工作組成員依據 GRADE 標準,對現有證據品質進行批判性反思
Structured group discussion: 結構化小組討論:
development of draft recommendation and their grading, considering GRADE-criteria. 考量 GRADE 標準,制定草案建議及其分級。
development of draft background texts, considering GRADE criteria. 考量 GRADE 標準,撰寫草案背景文本。
invitation to comment draft recommendations and background text to suggest reasonable amendments by group chairs. 由小組主席邀請對草案建議和背景文本提出評論,以建議合理修正。
collection and merging of amendments by group chairs. 由各小組主席收集並合併修正意見。
initial voting within the working group on recommendations and guideline text to be presented as group result in the plenary. 工作小組內部針對建議事項和指南文本進行初步投票,以作為全體會議中的小組成果呈現。
3.3.3 | Plenary 2 3.3.3 | 全體會議第二場
Presentation of working group results (draft recommendations and background text) by working group chairs. 由工作小組主席呈現工作成果(草案建議事項與背景文本)。
Invitation to formulate questions, statements and reasonable amendments of the plenary by the independent guideline methodologist/facilitator. 由獨立指南方法學家/協調員邀請提出問題、聲明及全體會議的合理修正案。
Answering of questions by working group chairpersons. 由工作小組主席回答問題。
Collection and merging of amendments by independent moderator. 由獨立調解員收集並整合修正案。
Preliminary vote on all suggestions provided by the working groups and all reasonable amendments. 對工作小組提出的所有建議及合理修正案進行初步表決。
Assessment of the strength of consensus. 評估共識強度。
Opening debate, where no consensus was reached or reasonable need for discussion was identified. 開啟辯論,在未達成共識或存在合理討論需求的情況下。
Formulation of tasks to be solved within the working groups. 制定工作小組需解決的任務。
3.3.4 | Working group Phase 2 3.3.4 | 第二階段工作小組
Discussion of tasks and potential amendments raised by the plenary. 全體會議中對任務及潛在修正案的討論。
Formulation of reasonable and justifiable amendments, considering the GRADE framework. 考量 GRADE 框架,制定合理且具正當性的修正案。
Initial voting within the working group on recommendations and guideline text for plenary. 工作小組內部針對全體會議的建議與指南文本進行初步表決。
3.3.5 | Plenary 3 3.3.5 | 全體會議 3
Presentation of working group results by working group chairpersons. 由工作小組主席進行工作小組成果報告。
Invitation to formulate questions, statements and reasonable amendments of the plenary by the independent moderator. 由獨立主持人邀請全體成員提出問題、聲明及合理修正案。
Collection and merging of amendments by independent moderator. 由獨立主持人收集並整合修正案。
Preliminary vote. 進行初步表決。
Assessment of the strength of consensus. 評估共識強度
Opening debate, where no consensus was reached or reasonable need for discussion was identified. 開啟辯論,在未達成共識或存在合理討論需求時
Formulation of reasonable alternatives. 制定合理替代方案
Final vote of each recommendation. 每項建議的最終表決
3.4 | Definitions: rating the quality of evidence, grading the strength of recommendations and determining the strength of consensus 3.4 | 定義:證據品質評級、建議強度分級與共識強度判定
For all recommendations and statements, this guideline makes transparent. 本指南對於所有建議與聲明皆保持透明化
the underlying quality of evidence, reflecting the degree of certainty/uncertainty of the evidence and robustness of study results 基礎證據品質,反映證據確定性/不確定性程度及研究結果的穩健性
the grade of the recommendation, reflecting criteria of considered judgement the strength of consensus, indicating the degree of agreement within the guideline panel and thus reflecting the need of implementation 建議等級,反映經過審慎判斷的標準;共識強度,顯示指南小組內部的同意程度,從而反映實施的必要性
3.4.1 | Quality of Evidence 3.4.1 | 證據品質
The quality of evidence was assessed using a recommended rating scheme (Balshem et al., 2011; Schunemann, Zhang, Oxman, & Expert Evidence in Guidelines, 2019). 證據品質評估採用推薦評分方案(Balshem 等人,2011 年;Schunemann、張、Oxman 與指南專家證據,2019 年)。
3.4.2 | Strength of Recommendations 3.4.2 | 建議強度
The grading of the recommendations used the grading scheme (Table 4) by the German Association of the Scientific Medical Societies (AWMF) and Standing Guidelines Commission (2012), taking into account not only the quality of evidence, but also considered judgement, guided by the following criteria: 建議等級的評定採用德國科學醫學學會協會(AWMF)與常設指南委員會(2012 年)制定的分級方案(表 4),不僅考量證據品質,同時依據以下標準進行判斷:
relevance of outcomes and quality of evidence for each relevant outcome 各相關結果的重要性與證據品質
consistency of study results 研究結果的一致性
directness regarding applicability of the evidence to the target population/PICO specifics 證據對於目標族群/PICO 特定情況的適用性直接程度
precision of effect estimates regarding confidence intervals 效果估計的精確度(關於信賴區間)
TABLE 3 PICOS questions addressed by each Systematic Review 表 3 各系統性文獻回顧所探討的 PICOS 問題
Reference 參考文獻
Systematic review title 系統性文獻回顧標題
Final PICOS (as written in manuscripts) 最終 PICOS(如手稿所述)
Suvan et al. (2019) Suvan 等人(2019 年)
Subgingival Instrumentation for Treatment of Periodontitis. A Systematic Review. 牙周炎治療之齦下器械刮治。系統性文獻回顧。
#1. In patients with periodontitis, what is the efficacy of subgingival instrumentation performed with hand or sonic/ultrasonic instruments in comparison with supragingival instrumentation or prophylaxis in terms of clinical and patient reported outcomes?
#2. In patients with periodontitis, what is the efficacy of nonsurgical subgingival instrumentation performed with sonic/ultrasonic instruments compared to subgingival instrumentation performed with hand instruments or compared to the subgingival instrumentation performed with a combination of hand and sonic/ultrasonic instruments in terms of clinical and patient-reported outcomes?
#3. In patients with periodontitis, what is the efficacy of full mouth delivery protocols (within 24 hr ) in comparison with quadrant or sextant wise delivery of subgingival mechanical instrumentation in terms of clinical and patient-reported outcomes?
#1. In patients with periodontitis, what is the efficacy of subgingival instrumentation performed with hand or sonic/ultrasonic instruments in comparison with supragingival instrumentation or prophylaxis in terms of clinical and patient reported outcomes?
#2. In patients with periodontitis, what is the efficacy of nonsurgical subgingival instrumentation performed with sonic/ultrasonic instruments compared to subgingival instrumentation performed with hand instruments or compared to the subgingival instrumentation performed with a combination of hand and sonic/ultrasonic instruments in terms of clinical and patient-reported outcomes?
#3. In patients with periodontitis, what is the efficacy of full mouth delivery protocols (within 24 hr ) in comparison with quadrant or sextant wise delivery of subgingival mechanical instrumentation in terms of clinical and patient-reported outcomes?| #1. In patients with periodontitis, what is the efficacy of subgingival instrumentation performed with hand or sonic/ultrasonic instruments in comparison with supragingival instrumentation or prophylaxis in terms of clinical and patient reported outcomes? |
| :--- |
| #2. In patients with periodontitis, what is the efficacy of nonsurgical subgingival instrumentation performed with sonic/ultrasonic instruments compared to subgingival instrumentation performed with hand instruments or compared to the subgingival instrumentation performed with a combination of hand and sonic/ultrasonic instruments in terms of clinical and patient-reported outcomes? |
| #3. In patients with periodontitis, what is the efficacy of full mouth delivery protocols (within 24 hr ) in comparison with quadrant or sextant wise delivery of subgingival mechanical instrumentation in terms of clinical and patient-reported outcomes? |
Salvi et al. (2019) Salvi 等人(2019 年)
Adjunctive laser or antimicrobial photodynamic therapy to non-surgical mechanical instrumentation in patients with untreated periodontitis. A systematic review and meta-analysis. 針對未經治療牙周炎患者,在非手術機械性器械治療基礎上輔助使用雷射或抗菌光動力療法的系統性文獻回顧與統合分析。
#1. In patients with untreated periodontitis, does laser application provide adjunctive effects to non-surgical mechanical instrumentation alone?
#2. In patients with untreated periodontitis, does application of a PTD provide adjunctive effects to non-surgical mechanical instrumentation alone?
#1. In patients with untreated periodontitis, does laser application provide adjunctive effects to non-surgical mechanical instrumentation alone?
#2. In patients with untreated periodontitis, does application of a PTD provide adjunctive effects to non-surgical mechanical instrumentation alone?| #1. In patients with untreated periodontitis, does laser application provide adjunctive effects to non-surgical mechanical instrumentation alone? |
| :--- |
| #2. In patients with untreated periodontitis, does application of a PTD provide adjunctive effects to non-surgical mechanical instrumentation alone? |
Donos et al. (2019) Donos 等人(2019 年)
The adjunctive use of host modulators in non-surgical periodontal therapy. A systematic review of randomized, placebo-controlled clinical studies 在非手術性牙周治療中輔助使用宿主調節劑。隨機安慰劑對照臨床研究的系統性回顧
In patients with periodontitis, what is the efficacy of adding host modulating agents instead of placebo to NSPT in terms of probing pocket depth (PPD) reduction? 對於牙周炎患者,在非手術性牙周治療中添加宿主調節劑相較於安慰劑,在探測牙周囊袋深度(PPD)減少方面的效果如何?
Sanz-Sanchez et al. (2020) Sanz-Sanchez 等人(2020)
Efficacy of access flaps compared to subgingival debridement or to different access flap approaches in the treatment of periodontitis. A systematic review and meta-analysis. 治療牙周炎時,進入瓣手術相較於牙齦下刮治或不同進入瓣手術方式的效果比較。系統性回顧與統合分析。
#1. In patients with periodontitis (population), how effective are access flaps (intervention) as compared to subgingival debridement (comparison) in attaining PD reduction (primary outcome)?
#2. In patients with periodontitis (population), does the type of access flaps (intervention and control) impact PD reduction (primary outcome)?
#1. In patients with periodontitis (population), how effective are access flaps (intervention) as compared to subgingival debridement (comparison) in attaining PD reduction (primary outcome)?
#2. In patients with periodontitis (population), does the type of access flaps (intervention and control) impact PD reduction (primary outcome)?| #1. In patients with periodontitis (population), how effective are access flaps (intervention) as compared to subgingival debridement (comparison) in attaining PD reduction (primary outcome)? |
| :--- |
| #2. In patients with periodontitis (population), does the type of access flaps (intervention and control) impact PD reduction (primary outcome)? |
Polak et al. (2020) Polak 等人(2020 年)
The Efficacy of Pocket Elimination/Reduction Surgery Vs. Access Flap: A Systematic Review 囊袋消除/縮減手術與翻瓣手術的療效比較:系統性文獻回顧
In adult patients with periodontitis after initial non-surgical cause-related therapy and residual PPD of 5 mm or more, what is the efficacy of pocket elimination/reduction surgery in comparison with access flap surgery? 對於已完成初期非手術性病因治療且殘留牙周囊袋深度達 5 毫米或以上的成年牙周炎患者,囊袋消除/縮減手術與翻瓣手術相比的療效為何?
Teughels et al. (2020) Teughels 等人 (2020)
Adjunctive effect of systemic antimicrobials in periodontitis therapy. A systematic review and meta-analysis. 全身性抗生素輔助治療牙周炎之效果:系統性文獻回顧與統合分析
In patients with periodontitis, which is the efficacy of adjunctive systemic antimicrobials, in comparison with subgingival debridement plus a placebo, in terms of probing pocket depth (PPD) reduction, in randomized clinical trials with at least 6 months of follow-up. 針對牙周炎患者,在隨機臨床試驗中追蹤至少 6 個月後,相較於齦下刮治配合安慰劑治療,輔助性全身抗生素治療在探測牙周囊袋深度(PPD)減少方面的療效評估
Herrera et al. (2020) Herrera 等人 (2020)
Adjunctive effect of locally delivered antimicrobials in periodontitis therapy. A systematic review and meta-analysis. 牙周炎治療中局部投予抗菌藥物的輔助效果。系統性文獻回顧與統合分析。
In adult patients with periodontitis, which is the efficacy of adjunctive locally delivered antimicrobials, in comparison with subgingival debridement alone or plus a placebo, in terms of probing pocket depth (PPD) reduction, in randomized clinical trials with at least 6 months of follow-up. 針對成年牙周炎患者,在隨機臨床試驗中至少 6 個月的追蹤期間,比較局部投予抗菌藥物作為輔助治療與僅進行牙齦下刮治或加上安慰劑,在探測牙周囊袋深度(PPD)減少方面的療效。
Nibali et al. (2019) Nibali 等人(2019 年)
Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis 再生性手術與翻瓣手術治療骨內牙周缺損之比較:系統性文獻回顧與統合分析
#1. Does regenerative surgery of intraosseous defects provide additional clinical benefits measured as Probing Pocket Depth (PPD) reduction, Clinical Attachment Level (CAL) gain, Recession (Rec) and Bone Gain (BG) in periodontitis patients compared with access flap?
#2. Is there a difference among regenerative procedures in terms of clinical and radiographic gains in intrabony defects?
#1. Does regenerative surgery of intraosseous defects provide additional clinical benefits measured as Probing Pocket Depth (PPD) reduction, Clinical Attachment Level (CAL) gain, Recession (Rec) and Bone Gain (BG) in periodontitis patients compared with access flap?
#2. Is there a difference among regenerative procedures in terms of clinical and radiographic gains in intrabony defects?| #1. Does regenerative surgery of intraosseous defects provide additional clinical benefits measured as Probing Pocket Depth (PPD) reduction, Clinical Attachment Level (CAL) gain, Recession (Rec) and Bone Gain (BG) in periodontitis patients compared with access flap? |
| :--- |
| #2. Is there a difference among regenerative procedures in terms of clinical and radiographic gains in intrabony defects? |
Jepsen et al. (2019) Jepsen 等人 (2019)
Regenerative surgical treatment of furcation defects: A systematic review and Bayesian network meta-analysis of randomized clinical trials 分叉缺損的再生手術治療:隨機臨床試驗之系統性回顧與貝氏網絡統合分析
#1. What is the efficacy of regenerative periodontal surgery in terms of tooth loss, furcation conversion and closure, horizontal clinical attachment level (HCAL) and bone level (HBL) gain as well as other periodontal parameters in teeth affected by periodontitis-related furcation defects, at least 12 months after surgery?
#2. NM: to establish a ranking in efficacy of the treatment options and to identify the best surgical technique.
#1. What is the efficacy of regenerative periodontal surgery in terms of tooth loss, furcation conversion and closure, horizontal clinical attachment level (HCAL) and bone level (HBL) gain as well as other periodontal parameters in teeth affected by periodontitis-related furcation defects, at least 12 months after surgery?
#2. NM: to establish a ranking in efficacy of the treatment options and to identify the best surgical technique.| #1. What is the efficacy of regenerative periodontal surgery in terms of tooth loss, furcation conversion and closure, horizontal clinical attachment level (HCAL) and bone level (HBL) gain as well as other periodontal parameters in teeth affected by periodontitis-related furcation defects, at least 12 months after surgery? |
| :--- |
| #2. NM: to establish a ranking in efficacy of the treatment options and to identify the best surgical technique. |
Reference Systematic review title Final PICOS (as written in manuscripts)
Suvan et al. (2019) Subgingival Instrumentation for Treatment of Periodontitis. A Systematic Review. "#1. In patients with periodontitis, what is the efficacy of subgingival instrumentation performed with hand or sonic/ultrasonic instruments in comparison with supragingival instrumentation or prophylaxis in terms of clinical and patient reported outcomes?
#2. In patients with periodontitis, what is the efficacy of nonsurgical subgingival instrumentation performed with sonic/ultrasonic instruments compared to subgingival instrumentation performed with hand instruments or compared to the subgingival instrumentation performed with a combination of hand and sonic/ultrasonic instruments in terms of clinical and patient-reported outcomes?
#3. In patients with periodontitis, what is the efficacy of full mouth delivery protocols (within 24 hr ) in comparison with quadrant or sextant wise delivery of subgingival mechanical instrumentation in terms of clinical and patient-reported outcomes?"
Salvi et al. (2019) Adjunctive laser or antimicrobial photodynamic therapy to non-surgical mechanical instrumentation in patients with untreated periodontitis. A systematic review and meta-analysis. "#1. In patients with untreated periodontitis, does laser application provide adjunctive effects to non-surgical mechanical instrumentation alone?
#2. In patients with untreated periodontitis, does application of a PTD provide adjunctive effects to non-surgical mechanical instrumentation alone?"
Donos et al. (2019) The adjunctive use of host modulators in non-surgical periodontal therapy. A systematic review of randomized, placebo-controlled clinical studies In patients with periodontitis, what is the efficacy of adding host modulating agents instead of placebo to NSPT in terms of probing pocket depth (PPD) reduction?
Sanz-Sanchez et al. (2020) Efficacy of access flaps compared to subgingival debridement or to different access flap approaches in the treatment of periodontitis. A systematic review and meta-analysis. "#1. In patients with periodontitis (population), how effective are access flaps (intervention) as compared to subgingival debridement (comparison) in attaining PD reduction (primary outcome)?
#2. In patients with periodontitis (population), does the type of access flaps (intervention and control) impact PD reduction (primary outcome)?"
Polak et al. (2020) The Efficacy of Pocket Elimination/Reduction Surgery Vs. Access Flap: A Systematic Review In adult patients with periodontitis after initial non-surgical cause-related therapy and residual PPD of 5 mm or more, what is the efficacy of pocket elimination/reduction surgery in comparison with access flap surgery?
Teughels et al. (2020) Adjunctive effect of systemic antimicrobials in periodontitis therapy. A systematic review and meta-analysis. In patients with periodontitis, which is the efficacy of adjunctive systemic antimicrobials, in comparison with subgingival debridement plus a placebo, in terms of probing pocket depth (PPD) reduction, in randomized clinical trials with at least 6 months of follow-up.
Herrera et al. (2020) Adjunctive effect of locally delivered antimicrobials in periodontitis therapy. A systematic review and meta-analysis. In adult patients with periodontitis, which is the efficacy of adjunctive locally delivered antimicrobials, in comparison with subgingival debridement alone or plus a placebo, in terms of probing pocket depth (PPD) reduction, in randomized clinical trials with at least 6 months of follow-up.
Nibali et al. (2019) Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis "#1. Does regenerative surgery of intraosseous defects provide additional clinical benefits measured as Probing Pocket Depth (PPD) reduction, Clinical Attachment Level (CAL) gain, Recession (Rec) and Bone Gain (BG) in periodontitis patients compared with access flap?
#2. Is there a difference among regenerative procedures in terms of clinical and radiographic gains in intrabony defects?"
Jepsen et al. (2019) Regenerative surgical treatment of furcation defects: A systematic review and Bayesian network meta-analysis of randomized clinical trials "#1. What is the efficacy of regenerative periodontal surgery in terms of tooth loss, furcation conversion and closure, horizontal clinical attachment level (HCAL) and bone level (HBL) gain as well as other periodontal parameters in teeth affected by periodontitis-related furcation defects, at least 12 months after surgery?
#2. NM: to establish a ranking in efficacy of the treatment options and to identify the best surgical technique."| Reference | Systematic review title | Final PICOS (as written in manuscripts) |
| :--- | :--- | :--- |
| Suvan et al. (2019) | Subgingival Instrumentation for Treatment of Periodontitis. A Systematic Review. | #1. In patients with periodontitis, what is the efficacy of subgingival instrumentation performed with hand or sonic/ultrasonic instruments in comparison with supragingival instrumentation or prophylaxis in terms of clinical and patient reported outcomes? <br> #2. In patients with periodontitis, what is the efficacy of nonsurgical subgingival instrumentation performed with sonic/ultrasonic instruments compared to subgingival instrumentation performed with hand instruments or compared to the subgingival instrumentation performed with a combination of hand and sonic/ultrasonic instruments in terms of clinical and patient-reported outcomes? <br> #3. In patients with periodontitis, what is the efficacy of full mouth delivery protocols (within 24 hr ) in comparison with quadrant or sextant wise delivery of subgingival mechanical instrumentation in terms of clinical and patient-reported outcomes? |
| Salvi et al. (2019) | Adjunctive laser or antimicrobial photodynamic therapy to non-surgical mechanical instrumentation in patients with untreated periodontitis. A systematic review and meta-analysis. | #1. In patients with untreated periodontitis, does laser application provide adjunctive effects to non-surgical mechanical instrumentation alone? <br> #2. In patients with untreated periodontitis, does application of a PTD provide adjunctive effects to non-surgical mechanical instrumentation alone? |
| Donos et al. (2019) | The adjunctive use of host modulators in non-surgical periodontal therapy. A systematic review of randomized, placebo-controlled clinical studies | In patients with periodontitis, what is the efficacy of adding host modulating agents instead of placebo to NSPT in terms of probing pocket depth (PPD) reduction? |
| Sanz-Sanchez et al. (2020) | Efficacy of access flaps compared to subgingival debridement or to different access flap approaches in the treatment of periodontitis. A systematic review and meta-analysis. | #1. In patients with periodontitis (population), how effective are access flaps (intervention) as compared to subgingival debridement (comparison) in attaining PD reduction (primary outcome)? <br> #2. In patients with periodontitis (population), does the type of access flaps (intervention and control) impact PD reduction (primary outcome)? |
| Polak et al. (2020) | The Efficacy of Pocket Elimination/Reduction Surgery Vs. Access Flap: A Systematic Review | In adult patients with periodontitis after initial non-surgical cause-related therapy and residual PPD of 5 mm or more, what is the efficacy of pocket elimination/reduction surgery in comparison with access flap surgery? |
| Teughels et al. (2020) | Adjunctive effect of systemic antimicrobials in periodontitis therapy. A systematic review and meta-analysis. | In patients with periodontitis, which is the efficacy of adjunctive systemic antimicrobials, in comparison with subgingival debridement plus a placebo, in terms of probing pocket depth (PPD) reduction, in randomized clinical trials with at least 6 months of follow-up. |
| Herrera et al. (2020) | Adjunctive effect of locally delivered antimicrobials in periodontitis therapy. A systematic review and meta-analysis. | In adult patients with periodontitis, which is the efficacy of adjunctive locally delivered antimicrobials, in comparison with subgingival debridement alone or plus a placebo, in terms of probing pocket depth (PPD) reduction, in randomized clinical trials with at least 6 months of follow-up. |
| Nibali et al. (2019) | Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis | #1. Does regenerative surgery of intraosseous defects provide additional clinical benefits measured as Probing Pocket Depth (PPD) reduction, Clinical Attachment Level (CAL) gain, Recession (Rec) and Bone Gain (BG) in periodontitis patients compared with access flap? <br> #2. Is there a difference among regenerative procedures in terms of clinical and radiographic gains in intrabony defects? |
| Jepsen et al. (2019) | Regenerative surgical treatment of furcation defects: A systematic review and Bayesian network meta-analysis of randomized clinical trials | #1. What is the efficacy of regenerative periodontal surgery in terms of tooth loss, furcation conversion and closure, horizontal clinical attachment level (HCAL) and bone level (HBL) gain as well as other periodontal parameters in teeth affected by periodontitis-related furcation defects, at least 12 months after surgery? <br> #2. NM: to establish a ranking in efficacy of the treatment options and to identify the best surgical technique. |
TABLE 3 (Continued) 表格 3(續)
Reference 參考文獻
Systematic review title 系統性文獻回顧標題
Final PICOS (as written in manuscripts) 最終 PICOS(如原稿所述)
Dommisch et al. (2020) Dommisch 等人 (2020)
Resective surgery for the treatment of furcation involvement: A systematic review 切除性手術治療根分叉病變:系統性文獻回顧
What is the benefit of resective surgical periodontal therapy (i.e. root amputation or resection, root separation, tunnel preparation) in (I) subjects with periodontitis who have completed a cycle of non-surgical periodontal therapy and exhibit Class II and III furcation involvement (P) compared to individuals suffering from periodontitis and exhibiting class II and III furcation involvement not being treated with resective surgical periodontal therapy but were not treated at all, treated exclusively by subgingival debridement or access flap surgery (C) with respect to 1) tooth survival (primary outcome), 2) vertical probing attachment (PAL-V) gain and 3) reduction of probing pocket depth (PPD) (secondary outcomes) (O) evidenced by randomized controlled clinical trials, prospective and retrospective cohort studies and case series with at least 12 months of follow-up (survival, PAL-V, PPD) (S), respectively. 對於已完成非手術性牙周治療且出現第二類和第三類根分叉病變的牙周炎患者(I),相較於患有牙周炎並出現第二類和第三類根分叉病變但未接受切除性牙周手術治療(完全未治療、僅接受齦下刮治或翻瓣手術)(C)的患者,切除性牙周手術治療(即根截除術、根分離術、隧道預備術)在以下方面的效益為何:1) 牙齒存活率(主要結果指標)、2) 垂直探測附著增益(PAL-V)及 3) 探測牙周囊袋深度(PPD)減少(次要結果指標)(O),證據來源包括隨機對照臨床試驗、前瞻性與回溯性世代研究以及追蹤期至少 12 個月(存活率、PAL-V、PPD)的病例系列報告(S)。
Slot et al. (2020) Slot 等人 (2020)
Mechanical plaque removal of periodontal maintenance patients: A systematic review and network meta-analysis 牙周維護患者機械性牙菌斑清除:系統性回顧與網絡統合分析
#1. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Power toothbrushes as compared to manual toothbrushes?
#2. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Interdental oral hygiene devices compared to no interdental cleaning as adjunct to toothbrushing?
#3. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Different interdental cleaning devices as adjuncts to toothbrushing
#1. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Power toothbrushes as compared to manual toothbrushes?
#2. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Interdental oral hygiene devices compared to no interdental cleaning as adjunct to toothbrushing?
#3. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Different interdental cleaning devices as adjuncts to toothbrushing| #1. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Power toothbrushes as compared to manual toothbrushes? |
| :--- |
| #2. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Interdental oral hygiene devices compared to no interdental cleaning as adjunct to toothbrushing? |
| #3. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Different interdental cleaning devices as adjuncts to toothbrushing |
Carra et al. (2020) Carra 等人(2020 年)
Promoting behavioural changes to improve oral hygiene in patients with periodontal diseases: a systematic review of the literature. 促進牙周病患者口腔衛生行為改變之文獻系統性回顧
What is the efficacy of behavioural interventions aimed to promote OH in patients with periodontal diseases (gingivitis/periodontitis), in improving clinical plaque and bleeding indices? 針對牙周疾病(牙齦炎/牙周炎)患者,旨在促進口腔衛生的行為介入措施,在改善臨床牙菌斑和出血指數方面的效果如何?
Ramseier et al. (2020) Ramseier 等人(2020)
Impact of risk factor control interventions for smoking cessation and promotion of healthy lifestyles in patients with periodontitis: a systematic review 針對牙周炎患者實施戒菸及促進健康生活型態的風險因子控制介入措施之影響:系統性文獻回顧
What is the efficacy of health behaviour change interventions for smoking cessation, diabetes control, physical exercise (activity), change of diet, carbohydrate (dietary sugar) reduction and weight loss provided in patients with periodontitis?". 針對牙周炎患者實施健康行為改變介入措施(包括戒菸、糖尿病控制、體能鍛鍊(活動)、飲食改變、碳水化合物(飲食糖分)減少及減重)的效果如何?
Figuero, Roldan, et al. (2019) Figuero、Roldan 等人 (2019)
Efficacy of adjunctive therapies in patients with gingival inflammation. A systematic review and meta-analysis. 輔助療法對牙齦發炎患者的療效:系統性文獻回顧與統合分析
In systemically healthy humans with dental plaque-induced gingival inflammation (with or without attachment loss, but excluding untreated periodontitis patients), what is the efficacy of agents used adjunctively to mechanical plaque control (either self-performed or professionally delivered), as compared to mechanical plaque control combined with a negative control, in terms of changes in gingival inflammation (through gingivitis or bleeding indices)? 針對全身健康但患有牙菌斑誘發牙齦發炎的患者(無論是否伴隨附連喪失,但排除未接受治療的牙周炎患者),相較於機械性牙菌斑控制配合安慰劑對照組,輔助使用其他製劑配合機械性牙菌斑控制(無論是自行操作或專業執行)在改善牙齦發炎(透過牙齦炎或出血指數評估)方面的療效為何?
Trombelli et al. (2020) Trombelli 等人 (2020)
Efficacy of alternative or additional methods to professional mechanical plaque removal during supportive periodontal therapy. A systematic review and meta-analysis 在支持性牙周治療期間,替代或輔助專業機械性牙菌斑清除方法之療效評估。系統性文獻回顧與統合分析
#1. What is the efficacy of alternative methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients?
#2. What is the efficacy of additional methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients?
#1. What is the efficacy of alternative methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients?
#2. What is the efficacy of additional methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients?| #1. What is the efficacy of alternative methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients? |
| :--- |
| #2. What is the efficacy of additional methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients? |
Reference Systematic review title Final PICOS (as written in manuscripts)
Dommisch et al. (2020) Resective surgery for the treatment of furcation involvement: A systematic review What is the benefit of resective surgical periodontal therapy (i.e. root amputation or resection, root separation, tunnel preparation) in (I) subjects with periodontitis who have completed a cycle of non-surgical periodontal therapy and exhibit Class II and III furcation involvement (P) compared to individuals suffering from periodontitis and exhibiting class II and III furcation involvement not being treated with resective surgical periodontal therapy but were not treated at all, treated exclusively by subgingival debridement or access flap surgery (C) with respect to 1) tooth survival (primary outcome), 2) vertical probing attachment (PAL-V) gain and 3) reduction of probing pocket depth (PPD) (secondary outcomes) (O) evidenced by randomized controlled clinical trials, prospective and retrospective cohort studies and case series with at least 12 months of follow-up (survival, PAL-V, PPD) (S), respectively.
Slot et al. (2020) Mechanical plaque removal of periodontal maintenance patients: A systematic review and network meta-analysis "#1. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Power toothbrushes as compared to manual toothbrushes?
#2. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Interdental oral hygiene devices compared to no interdental cleaning as adjunct to toothbrushing?
#3. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Different interdental cleaning devices as adjuncts to toothbrushing"
Carra et al. (2020) Promoting behavioural changes to improve oral hygiene in patients with periodontal diseases: a systematic review of the literature. What is the efficacy of behavioural interventions aimed to promote OH in patients with periodontal diseases (gingivitis/periodontitis), in improving clinical plaque and bleeding indices?
Ramseier et al. (2020) Impact of risk factor control interventions for smoking cessation and promotion of healthy lifestyles in patients with periodontitis: a systematic review What is the efficacy of health behaviour change interventions for smoking cessation, diabetes control, physical exercise (activity), change of diet, carbohydrate (dietary sugar) reduction and weight loss provided in patients with periodontitis?".
Figuero, Roldan, et al. (2019) Efficacy of adjunctive therapies in patients with gingival inflammation. A systematic review and meta-analysis. In systemically healthy humans with dental plaque-induced gingival inflammation (with or without attachment loss, but excluding untreated periodontitis patients), what is the efficacy of agents used adjunctively to mechanical plaque control (either self-performed or professionally delivered), as compared to mechanical plaque control combined with a negative control, in terms of changes in gingival inflammation (through gingivitis or bleeding indices)?
Trombelli et al. (2020) Efficacy of alternative or additional methods to professional mechanical plaque removal during supportive periodontal therapy. A systematic review and meta-analysis "#1. What is the efficacy of alternative methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients?
#2. What is the efficacy of additional methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients?"| Reference | Systematic review title | Final PICOS (as written in manuscripts) |
| :--- | :--- | :--- |
| Dommisch et al. (2020) | Resective surgery for the treatment of furcation involvement: A systematic review | What is the benefit of resective surgical periodontal therapy (i.e. root amputation or resection, root separation, tunnel preparation) in (I) subjects with periodontitis who have completed a cycle of non-surgical periodontal therapy and exhibit Class II and III furcation involvement (P) compared to individuals suffering from periodontitis and exhibiting class II and III furcation involvement not being treated with resective surgical periodontal therapy but were not treated at all, treated exclusively by subgingival debridement or access flap surgery (C) with respect to 1) tooth survival (primary outcome), 2) vertical probing attachment (PAL-V) gain and 3) reduction of probing pocket depth (PPD) (secondary outcomes) (O) evidenced by randomized controlled clinical trials, prospective and retrospective cohort studies and case series with at least 12 months of follow-up (survival, PAL-V, PPD) (S), respectively. |
| Slot et al. (2020) | Mechanical plaque removal of periodontal maintenance patients: A systematic review and network meta-analysis | #1. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Power toothbrushes as compared to manual toothbrushes? <br> #2. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Interdental oral hygiene devices compared to no interdental cleaning as adjunct to toothbrushing? <br> #3. In periodontal maintenance patients, what is the effect on plaque removal and parameters of periodontal health of the following: Different interdental cleaning devices as adjuncts to toothbrushing |
| Carra et al. (2020) | Promoting behavioural changes to improve oral hygiene in patients with periodontal diseases: a systematic review of the literature. | What is the efficacy of behavioural interventions aimed to promote OH in patients with periodontal diseases (gingivitis/periodontitis), in improving clinical plaque and bleeding indices? |
| Ramseier et al. (2020) | Impact of risk factor control interventions for smoking cessation and promotion of healthy lifestyles in patients with periodontitis: a systematic review | What is the efficacy of health behaviour change interventions for smoking cessation, diabetes control, physical exercise (activity), change of diet, carbohydrate (dietary sugar) reduction and weight loss provided in patients with periodontitis?". |
| Figuero, Roldan, et al. (2019) | Efficacy of adjunctive therapies in patients with gingival inflammation. A systematic review and meta-analysis. | In systemically healthy humans with dental plaque-induced gingival inflammation (with or without attachment loss, but excluding untreated periodontitis patients), what is the efficacy of agents used adjunctively to mechanical plaque control (either self-performed or professionally delivered), as compared to mechanical plaque control combined with a negative control, in terms of changes in gingival inflammation (through gingivitis or bleeding indices)? |
| Trombelli et al. (2020) | Efficacy of alternative or additional methods to professional mechanical plaque removal during supportive periodontal therapy. A systematic review and meta-analysis | #1. What is the efficacy of alternative methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients? <br> #2. What is the efficacy of additional methods to professional mechanical plaque removal (PMPR) on progression of attachment loss during supportive periodontal therapy (SPT) in periodontitis patients? |
We recommend (uarr uarr)//(\uparrow \uparrow) / We recommend not to ( darr darr\downarrow \downarrow ) 我們建議 (uarr uarr)//(\uparrow \uparrow) / 我們建議不要 ( darr darr\downarrow \downarrow )
B
Recommendation 建議
We suggest to ( uarr\uparrow )/ We suggest not to ( darr\downarrow ) 我們建議( uarr\uparrow )/我們不建議( darr\downarrow )
0
Open recommendation 開放性建議
May be considered ( harr\leftrightarrow ) 可考慮( harr\leftrightarrow )
Grade of recommendation grade ^("a ") Description Syntax
A Strong recommendation We recommend (uarr uarr)// We recommend not to ( darr darr )
B Recommendation We suggest to ( uarr )/ We suggest not to ( darr )
0 Open recommendation May be considered ( harr )| Grade of recommendation grade ${ }^{\text {a }}$ | Description | Syntax |
| :--- | :--- | :--- |
| A | Strong recommendation | We recommend $(\uparrow \uparrow) /$ We recommend not to ( $\downarrow \downarrow$ ) |
| B | Recommendation | We suggest to ( $\uparrow$ )/ We suggest not to ( $\downarrow$ ) |
| 0 | Open recommendation | May be considered ( $\leftrightarrow$ ) |
^("a "){ }^{\text {a }} If the group felt that evidence was not clear enough to support a recommendation, Statements were formulated, including the need (or not) of additional research. ^("a "){ }^{\text {a }} 若小組認為證據不足以支持建議時,將制定聲明,包括是否需要進一步研究。
TABLE 4 Strength of recommendations: grading scheme (German Association of the Scientific Medical Societies (AWMF) and Standing Guidelines Commission, 2012) 表 4 建議強度分級方案(德國科學醫學學會協會(AWMF)與常設指南委員會,2012 年)
The grading of the quality of evidence and the strength of a recommendation may therefore differ in justified cases. 因此,在合理的情況下,證據品質的評級和建議強度可能會有所不同。
3.4.3 | Strength of consensus 3.4.3 | 共識強度
The consensus determination process followed the recommendations by the German Association of the Scientific Medical Societies (AWMF) and Standing Guidelines Commission (2012). In case, consensus could not be reached, different points of view were documented in the guideline text. See Table 5. 共識確定過程遵循德國科學醫學學會協會(AWMF)和常設指南委員會(2012 年)的建議。若無法達成共識,則會在指南文本中記錄不同的觀點。詳見表 5。
3.5 | Editorial independence 3.5 | 編輯獨立性
3.5.1 | Funding of the guideline 3.5.1 | 臨床指引資金來源
The development of this guideline and its subsequent publication were financed entirely by internal funds of the European Federation of Periodontology, without any support from industry or other organizations. 本臨床指引的制定與後續出版完全由歐洲牙周病學聯合會內部資金資助,未接受任何產業或其他組織的支援。
3.5.2 | Declaration of interests and management of potential conflicts 3.5.2 | 利益聲明與潛在利益衝突管理
All members of the guideline panel declared secondary interests using the standardized form provided by the International Committee of Medical Journal Editors (ICMJE) (International Committee of Medical Editors). 本指南小組所有成員均使用國際醫學期刊編輯委員會(ICMJE)提供的標準化表格申報次要利益關係。
Management of conflict of interests (Cols) was discussed in the working groups, following the principles provided by the Guidelines International Network (Schunemann et al., 2015). According to these principles, panel members with relevant, potential Col abstained from voting on guideline statements and recommendations within the consensus process. 利益衝突管理遵循國際指南網絡(Schunemann 等人,2015 年)提供的原則,在工作小組中進行討論。根據這些原則,具有相關潛在利益衝突的小組成員在共識過程中對指南聲明和建議的投票採取迴避態度。
3.6 | Peer review 3.6 | 同儕審查
All 15 systematic reviews, and the position paper on outcome variables commissioned for this guideline, underwent a multistep peer review process. First, the draft documents were evaluated by members of the EFP Workshop Committee and the methodological consultants using a custom-made appraisal tool to assess (a) the methodological quality of the SRs using the AMSTAR 2 checklist (Shea et al., 2017), and (b) whether all PICO(S) questions were addressed as planned. Detailed feedback was then provided for the SR 為本指南委託進行的 15 篇系統性文獻回顧及結果變量立場論文,均經過多階段同儕審查程序。首先由 EFP 工作坊委員會成員和方法學顧問使用自製評估工具對草案文件進行評審,評估內容包括:(a)使用 AMSTAR 2 檢查表(Shea 等人,2017 年)評估系統性回顧的方法學品質,(b)確認所有 PICO(S)問題是否按計劃處理。隨後針對系統性回顧提供詳細反饋意見。
authors. Subsequently, all 15 systematic reviews and the position paper underwent the regular editorial peer review process defined by the Journal of Clinical Periodontology. 作者群。隨後,所有 15 篇系統性文獻回顧與立場文件均依照《臨床牙周病學期刊》規定的標準編輯同儕審查程序進行審核。
The guideline text was drafted by the chairs of the working groups, in close cooperation with the methodological consultants, and circulated in the guideline group before the workshop. The methodological quality was formally assessed by an outside consultant using the AGREE framework. The guideline was subsequently peer-reviewed for its publication in the Journal of Clinical Periodontology following the standard evaluation process of this scientific journal. 本指南文本由各工作小組主席與方法學顧問密切合作起草,並於研討會前在指南小組內傳閱徵求意見。方法學品質由外部顧問採用 AGREE 框架進行正式評估。本指南後續依照該科學期刊的標準評審流程,通過《臨床牙周病學期刊》的同儕審查後發表。
3.7 | Implementation and dissemination plan 3.7 | 實施與推廣計劃
For this guideline, a multistage dissemination and implementation strategy will be actioned by the EFP, supported by a communication campaign. 歐洲牙周病學聯盟(EFP)將透過傳播活動支持,採取多階段推廣與實施策略來落實本指南。
This will include the following: 這將包含以下內容:
Publication of the guideline and the underlying systematic reviews and position paper as an Open Access special issue of the Journal of Clinical Periodontology 將該指南及相關系統性回顧與立場文件以開放取閱形式發表於《臨床牙周病學期刊》特刊
Local uptake from national societies, either by Commentary, Adoption, or Adaptation (Schunemann et al., 2017) 由各國學會進行在地化採納,方式包括評論、直接採用或調整適用(Schunemann 等人,2017 年)
Generation of educational material for dental professionals and patients, dissemination via the EFP member societies 製作牙科專業人員與患者的教育材料,並透過 EFP 會員學會進行推廣
Dissemination via educational programmes on dental conferences 透過牙科會議的教育計畫進行推廣
Dissemination via EFP through European stakeholders via National Societies, members of EFP 透過歐洲牙周病學基金會(EFP)的歐洲利益相關者,經由各國學會及 EFP 會員進行推廣
Long-term evaluation of the successful implementation of the guideline by poll of EFP members. 透過 EFP 會員調查,長期評估該指南的成功實施情況
The timeline of the guideline development process is detailed in Table 6. 指南制定流程的時間表詳見表 6。
3.8 | Validity and update process 3.8 | 有效性與更新流程
The guideline is valid until 2025. However, the EFP, represented by the members of the Organizing Committee, will continuously assess current developments in the field. In case of major changes of circumstances, for example new relevant evidence, they will trigger an update of the guideline to potentially amend the recommendations. It is planned to update the current guideline regularly on demand in form of a living guideline. 本指南有效期至 2025 年。然而,歐洲牙周病學會(EFP)將透過組織委員會成員持續評估該領域的最新發展。若出現重大情況變化(例如新的相關證據),將啟動指南更新程序以可能修訂建議內容。計劃以「動態指南」形式根據需求定期更新現行指南。
4 | PERIODONTAL DIAGNOSIS AND CLASSIFICATION 4 | 牙周診斷與分類
Periodontal diagnosis has been followed according to the classification scheme defined in the 2017 World Workshop on the 牙周診斷係依據 2017 年世界研討會所定義的分類方案進行
TABLE 5 Strength of consensus: determination scheme (German Association of the Scientific Medical Societies (AWMF) and Standing Guidelines Commission, 2012) 表 5 共識強度:判定方案(德國科學醫學學會協會(AWMF)與常設準則委員會,2012 年)
Unanimous consensus 全體一致共識
Agreement of 100% of participants 100%參與者同意
Strong consensus 強烈共識
Agreement of > 95% of participants 超過 95%參與者同意
Consensus 共識
Agreement of 75%-95% of participants 75%-95%參與者同意
Simple majority 簡單多數
Agreement of 50%-74% of participants 50%-74%參與者達成共識
No consensus 未達成共識
Agreement of < 50% of participants 少於 50%參與者達成共識
Unanimous consensus Agreement of 100% of participants
Strong consensus Agreement of > 95% of participants
Consensus Agreement of 75%-95% of participants
Simple majority Agreement of 50%-74% of participants
No consensus Agreement of < 50% of participants| Unanimous consensus | Agreement of 100% of participants |
| :--- | :--- |
| Strong consensus | Agreement of > 95% of participants |
| Consensus | Agreement of 75%-95% of participants |
| Simple majority | Agreement of 50%-74% of participants |
| No consensus | Agreement of < 50% of participants |
Classification of Periodontal and Peri-Implant Diseases and Conditions (Caton et al., 2018; Chapple et al., 2018; Jepsen et al., 2018; Papapanou et al., 2018). 牙周及植體周圍疾病與狀況分類(Caton 等人,2018;Chapple 等人,2018;Jepsen 等人,2018;Papapanou 等人,2018)
According to this classification: 根據此分類:
A case of clinical periodontal health is defined by the absence of inflammation [measured as presence of bleeding on probing (BOP) at less than 10% sites] and the absence of attachment and bone loss arising from previous periodontitis. 臨床牙周健康的定義是沒有發炎[以探測出血(BOP)少於 10%的位點為測量標準],且沒有因先前牙周炎導致的附連喪失和骨骼流失。
A gingivitis case is defined by the presence of gingival inflammation, as assessed by BOP at >= 10%\geq 10 \% sites and absence of detectable attachment loss due to previous periodontitis. Localized gingivitis is defined as 10%-30%10 \%-30 \% bleeding sites, while generalized gingivitis is defined as >30% bleeding sites 牙齦炎的定義是存在牙齦發炎,以 BOP 在 >= 10%\geq 10 \% 位點為評估標準,且沒有可檢測到因先前牙周炎導致的附連喪失。局部性牙齦炎定義為 10%-30%10 \%-30 \% 出血位點,而廣泛性牙齦炎則定義為超過 30%的出血位點。
A periodontitis case is defined by the loss of periodontal tissue support, which is commonly assessed by radiographic bone loss or interproximal loss of clinical attachment measured by probing. Other meaningful descriptions of periodontitis include the number and proportions of teeth with probing pocket depth over certain thresholds (commonly > 4mm>4 \mathrm{~mm} with BOP and >= 6mm\geq 6 \mathrm{~mm} ), the number of teeth lost due to periodontitis, the number of teeth with intrabony lesions and the number of teeth with furcation lesions. 牙周炎的定義是牙周組織支持的喪失,通常以放射線檢查顯示的骨骼流失或探測測量的臨床附連近端喪失來評估。其他對牙周炎有意義的描述包括:探測袋深度超過特定閾值(通常為 > 4mm>4 \mathrm{~mm} 伴隨 BOP 和 >= 6mm\geq 6 \mathrm{~mm} )的牙齒數量和比例、因牙周炎喪失的牙齒數量、具有骨內病變的牙齒數量,以及具有分叉病變的牙齒數量。
An individual case of periodontitis should be further characterized using a matrix that describes the stage and grade of the disease. Stage is largely dependent upon the severity of disease at presentation, as well as on the anticipated complexity of case management, and further includes a description of extent and distribution of the disease in the dentition. Grade provides supplemental information about biological features of the disease including a history-based analysis of the rate of periodontitis progression; assessment of the risk for further progression; analysis of possible poor outcomes of treatment; and assessment of the risk that the disease or its treatment may negatively affect the general health of the patient. The staging, which is dependent on the severity of the disease and the anticipated complexity of case management, should be the basis for the patient’s treatment plan based on the scientific evidence of the different therapeutic interventions. The grade, however, since it provides supplemental information on the patient’s risk factors and rate of progression, should be the basis for individual planning of care (Tables 7 and 8) (Papapanou et al., 2018; Tonetti, Greenwell, & Kornman, 2018). 針對個別的牙周炎病例,應進一步使用描述疾病分期與分級的矩陣來進行表徵。分期主要取決於就診時疾病的嚴重程度,以及預期的病例管理複雜性,並進一步包含對疾病在齒列中範圍與分布的描述。分級則提供有關疾病生物學特徵的補充資訊,包括基於病史的牙周炎進展速率分析、進一步惡化風險的評估、治療可能不良結果的分析,以及評估疾病或其治療可能對患者整體健康產生負面影響的風險。基於疾病嚴重程度和預期病例管理複雜性的分期,應成為患者治療計劃的基礎,並根據不同治療干預措施的科學證據來制定。 然而,由於分級提供了患者風險因素和疾病進展速度的補充資訊,應作為個別治療計畫的基礎(表 7 和表 8)(Papapanou 等人,2018;Tonetti、Greenwell 和 Kornman,2018)。
TABLE 6 Timeline of the guideline development process 表 6 臨床指引制定流程時程表
Time point 時間點
Action 行動
April 2018 2018 年 4 月
Decision by European Federation of Periodontology (EFP) General Assembly to develop comprehensive treatment guidelines for periodontitis 歐洲牙周病學聯盟(EFP)大會決議制定牙周炎全面治療指南
May-September 2018 2018 年 5 月至 9 月
EFP Workshop Committee assesses merits and disadvantages of various established methodologies and their applicability to the field 歐洲牙周病學基金會工作坊委員會評估各種既定方法的優缺點及其在該領域的適用性
September 2018 2018 年 9 月
EFP Workshop Committee decides on/ invites (a) topics covered by proposed guideline, (b) working groups and chairs, (c) systematic reviewers, and (d) outcomes measures 歐洲牙周病學基金會工作坊委員會決定/邀請:(a)擬議指南涵蓋的主題,(b)工作小組及主席,(c)系統性文獻回顧人員,以及(d)結果衡量指標
Submission of PICO(S) questions by systematic reviewers to group chairs for internal alignment
Decision on consensus group, invitation of stakeholders
Submission of PICO(S) questions by systematic reviewers to group chairs for internal alignment
Decision on consensus group, invitation of stakeholders| Submission of PICO(S) questions by systematic reviewers to group chairs for internal alignment |
| :--- |
| Decision on consensus group, invitation of stakeholders |
21 January 2019 2019 年 1 月 21 日
Organizing and Advisor Committee meeting. Decision on PICO(S)\mathrm{PICO}(\mathrm{S}) and information sent to reviewers 籌備暨顧問委員會會議。決定 PICO(S)\mathrm{PICO}(\mathrm{S}) 並將相關資訊發送給審查人員
March-June 2019 2019 年 3 月至 6 月
Submission of Systematic reviews by reviewers, initial assessment by workshop committee 審查人員提交系統性文獻回顧,由工作坊委員會進行初步評估
June-October 2019 2019 年 6 月至 10 月
Peer review and revision process, Journal of Clinical Periodontology 同儕審查與修訂流程,《臨床牙周病學期刊》
September 2019 2019 年 9 月
Submission of declarations of interest by all delegates 所有與會者提交利益聲明
Before workshop 工作坊前
Electronic circulation of reviews and guideline draft 電子傳閱審查報告與指南草案
10-13 November 2019 2019 年 11 月 10-13 日
Workshop in La Granja with moderated formalized consensus process 於拉格蘭哈舉行工作坊,採用調節式正式共識流程
December 2019January 2020 2019 年 12 月至 2020 年 1 月
Formal stakeholder consultation, finalization of guideline method report and background text 進行正式利益相關者諮詢,完成指南方法報告與背景文本定稿
April 2020 2020 年 4 月
Publication of guideline and underlying Systematic Reviews in the Journal of Clinical Periodontology 臨床牙周病學期刊發表治療指南及相關系統性文獻回顧
Time point Action
April 2018 Decision by European Federation of Periodontology (EFP) General Assembly to develop comprehensive treatment guidelines for periodontitis
May-September 2018 EFP Workshop Committee assesses merits and disadvantages of various established methodologies and their applicability to the field
September 2018 EFP Workshop Committee decides on/ invites (a) topics covered by proposed guideline, (b) working groups and chairs, (c) systematic reviewers, and (d) outcomes measures
End of year 2018 "Submission of PICO(S) questions by systematic reviewers to group chairs for internal alignment
Decision on consensus group, invitation of stakeholders"
21 January 2019 Organizing and Advisor Committee meeting. Decision on PICO(S) and information sent to reviewers
March-June 2019 Submission of Systematic reviews by reviewers, initial assessment by workshop committee
June-October 2019 Peer review and revision process, Journal of Clinical Periodontology
September 2019 Submission of declarations of interest by all delegates
Before workshop Electronic circulation of reviews and guideline draft
10-13 November 2019 Workshop in La Granja with moderated formalized consensus process
December 2019January 2020 Formal stakeholder consultation, finalization of guideline method report and background text
April 2020 Publication of guideline and underlying Systematic Reviews in the Journal of Clinical Periodontology| Time point | Action |
| :--- | :--- |
| April 2018 | Decision by European Federation of Periodontology (EFP) General Assembly to develop comprehensive treatment guidelines for periodontitis |
| May-September 2018 | EFP Workshop Committee assesses merits and disadvantages of various established methodologies and their applicability to the field |
| September 2018 | EFP Workshop Committee decides on/ invites (a) topics covered by proposed guideline, (b) working groups and chairs, (c) systematic reviewers, and (d) outcomes measures |
| End of year 2018 | Submission of PICO(S) questions by systematic reviewers to group chairs for internal alignment <br> Decision on consensus group, invitation of stakeholders |
| 21 January 2019 | Organizing and Advisor Committee meeting. Decision on $\mathrm{PICO}(\mathrm{S})$ and information sent to reviewers |
| March-June 2019 | Submission of Systematic reviews by reviewers, initial assessment by workshop committee |
| June-October 2019 | Peer review and revision process, Journal of Clinical Periodontology |
| September 2019 | Submission of declarations of interest by all delegates |
| Before workshop | Electronic circulation of reviews and guideline draft |
| 10-13 November 2019 | Workshop in La Granja with moderated formalized consensus process |
| December 2019January 2020 | Formal stakeholder consultation, finalization of guideline method report and background text |
| April 2020 | Publication of guideline and underlying Systematic Reviews in the Journal of Clinical Periodontology |
After the completion of periodontal therapy, a stable periodontitis patient has been defined by gingival health on a reduced periodontium (bleeding on probing in < 10%<10 \% of the sites; shallow probing depths of 4 mm or less and no 4 mm sites with bleeding on probing). When, after the completion of periodontal treatment, these criteria are met but bleeding on probing is present at > 10%>10 \% of sites, then the patient is diagnosed as a stable periodontitis patient with gingival inflammation. Sites with persistent probing depths >= 4mm\geq 4 \mathrm{~mm} which exhibit BOP are likely to be unstable and require further treatment. It should be recognized that successfully treated and stable periodontitis patients will remain at increased risk of recurrent periodontitis, and hence if gingival inflammation is present adequate measures for inflammation control should be implemented to prevent recurrent periodontitis. 牙周治療完成後,穩定的牙周炎患者定義為:在縮減的牙周組織上呈現牙齦健康狀態(探診出血部位比例為 < 10%<10 \% ;探測深度不超過 4 毫米且無探診出血的 4 毫米部位)。若治療完成後符合上述標準,但仍有 > 10%>10 \% 比例的探診出血部位,則診斷為「伴有牙齦發炎的穩定型牙周炎患者」。持續存在 >= 4mm\geq 4 \mathrm{~mm} 探測深度且伴隨探診出血的部位可能處於不穩定狀態,需進一步治療。需注意的是,即使成功治療的穩定型牙周炎患者,其牙周炎復發風險仍較高,因此若出現牙齦發炎症狀,應採取適當的發炎控制措施以預防復發。
TABLE 7 Periodontitis stage. Adapted from Tonetti et al. (2018) 表 7 牙周炎分期(改編自 Tonetti 等人 2018 年研究)
Periodontitis stage 牙周炎分期
Stage I 第一期
Stage II 第二期
Stage III 第三期
Stage IV 第四期
Severity 嚴重程度
Interdental CAL at site of greatest loss 最大缺損處的鄰間牙周附連喪失
1 to 2 mm 1 至 2 毫米
3 to 4 mm 3 至 4 毫米
>= 5mm\geq 5 \mathrm{~mm}
>= 5mm\geq 5 \mathrm{~mm}
Radiographic bone loss 放射線影像骨骼流失
Coronal third (<15%) 冠部三分之一(<15%)
Coronal third (15% to 33%) 冠部三分之一(15% 至 33%)
Extending to middle or apical third of the root 延伸至牙根中段或根尖三分之一處
Extending to middle or apical third of the root 延伸至牙根中段或根尖三分之一處
Tooth loss 牙齒缺失
No tooth loss due to periodontitis 無因牙周炎導致牙齒缺失
Tooth loss due to periodontitis of <= 4\leq 4 teeth 因牙周炎導致的牙齒缺失,共 <= 4\leq 4 顆
Tooth loss due to periodontitis of >= 5\geq 5 teeth 因牙周炎導致的牙齒缺失,共 >= 5\geq 5 顆
Vertical bone loss >= 3mm
Furcation involvement Class II or III
Moderate ridge defect| Vertical bone loss $\geq 3 \mathrm{~mm}$ |
| :--- |
| Furcation involvement Class II or III |
| Moderate ridge defect |
For each stage, describe extent as localized (<30% of teeth involved), generalized, or molar/incisor pattern 對於每個階段,將範圍描述為局部性(涉及牙齒少於 30%)、廣泛性,或臼齒/門齒型態
Periodontitis stage Stage I Stage II Stage III Stage IV
Severity Interdental CAL at site of greatest loss 1 to 2 mm 3 to 4 mm >= 5mm >= 5mm
Radiographic bone loss Coronal third (<15%) Coronal third (15% to 33%) Extending to middle or apical third of the root Extending to middle or apical third of the root
Tooth loss No tooth loss due to periodontitis Tooth loss due to periodontitis of <= 4 teeth Tooth loss due to periodontitis of >= 5 teeth
Complexity In addition to stage II complexity: In addition to stage III complexity:
Maximum probing depth <= 4mm Maximum probing depth <= 5mm Probing depth >= 6mm Need for complex rehabilitation due to:
Local Mostly horizontal bone loss Mostly horizontal bone loss "Vertical bone loss >= 3mm
Furcation involvement Class II or III
Moderate ridge defect" "Masticatory dysfunction
Secondary occlusal trauma (tooth mobility degree >= 2 )
Severe ridge defect
Bite collapse, drifting, flaring
Less than 20 remaining teeth (10 opposing pairs)"
Extent and distribution Add to stage as descriptor For each stage, describe extent as localized (<30% of teeth involved), generalized, or molar/incisor pattern | Periodontitis stage | | Stage I | Stage II | Stage III | Stage IV |
| :--- | :--- | :--- | :--- | :--- | :--- |
| Severity | Interdental CAL at site of greatest loss | 1 to 2 mm | 3 to 4 mm | $\geq 5 \mathrm{~mm}$ | $\geq 5 \mathrm{~mm}$ |
| | Radiographic bone loss | Coronal third (<15%) | Coronal third (15% to 33%) | Extending to middle or apical third of the root | Extending to middle or apical third of the root |
| | Tooth loss | No tooth loss due to periodontitis | | Tooth loss due to periodontitis of $\leq 4$ teeth | Tooth loss due to periodontitis of $\geq 5$ teeth |
| Complexity | | | | In addition to stage II complexity: | In addition to stage III complexity: |
| | | Maximum probing depth $\leq 4 \mathrm{~mm}$ | Maximum probing depth $\leq 5 \mathrm{~mm}$ | Probing depth $\geq 6 \mathrm{~mm}$ | Need for complex rehabilitation due to: |
| | Local | Mostly horizontal bone loss | Mostly horizontal bone loss | Vertical bone loss $\geq 3 \mathrm{~mm}$ <br> Furcation involvement Class II or III <br> Moderate ridge defect | Masticatory dysfunction <br> Secondary occlusal trauma (tooth mobility degree $\geq 2$ ) <br> Severe ridge defect <br> Bite collapse, drifting, flaring <br> Less than 20 remaining teeth (10 opposing pairs) |
| Extent and distribution | Add to stage as descriptor | For each stage, describe extent as localized (<30% of teeth involved), generalized, or molar/incisor pattern | | | |
Note: The initial Stage should be determined using CAL; if not available then RBL should be used. Information on tooth loss that can be attributed primarily to periodontitis - if available - may modify stage definition. This is the case even in the absence of complexity factors. Complexity factors may shift the Stage to a higher level, for example furcation II or III would shift to either Stage III or IV irrespective of the CAL. The distinction between Stage III and Stage IV is primarily based on complexity factors. For example, a high level of tooth mobility and/or posterior bite collapse would indicate a Stage IV diagnosis. For any given case only some, not all, complexity factors may be present, however, in general it only takes 1 complexity factor to shift the diagnosis to a higher Stage. It should be emphasized that these case definitions are guidelines that should be applied using sound clinical judgment to arrive at the most appropriate clinical diagnosis. 註:初始階段應使用臨床附著喪失(CAL)來判定;若無法取得則應使用放射線骨喪失(RBL)。若可取得主要歸因於牙周炎的牙齒喪失資訊,可能需調整階段定義。即使缺乏複雜性因素,此情況仍適用。複雜性因素可能使階段提升至更高層級,例如分叉病變 II 或 III 級將使階段提升至 III 或 IV 期,不論 CAL 數值為何。III 期與 IV 期之間的區分主要基於複雜性因素。舉例來說,高度牙齒動搖和/或後牙咬合崩潰將顯示為 IV 期診斷。對於任何特定病例,可能僅存在部分而非所有複雜性因素,然而一般而言,僅需 1 項複雜性因素即可將診斷提升至更高階段。必須強調這些病例定義是指引準則,應運用合理的臨床判斷以達成最適切的臨床診斷。
For post-treatment patients CAL and RBL are still the primary stage determinants. If a stage shifting complexity factor(s) were eliminated by treatment, the stage should not retrogress to a lower stage since the original stage complexity factor should always be considered in maintenance phase management. 對於治療後的患者,臨床附著喪失(CAL)和放射線骨質流失(RBL)仍是分期的主要判定依據。若治療已消除導致分期複雜化的因素,則不應將分期回溯至較低階段,因在維護期管理中仍需考量原始分期的複雜性因素。
Abbreviations: CAL, clinical attachment loss; RBL, radiographic bone loss. 縮寫說明:CAL,臨床附著喪失;RBL,放射線骨質流失。
4.1 | Clinical pathway for a diagnosis of periodontitis 4.1 | 牙周炎診斷臨床路徑
A proposed algorithm has been used by the EFP to assist clinicians with this periodontal diagnosis process when examining a new patient (Tonetti & Sanz, 2019). It consists of four sequential steps: 歐洲牙周病學會(EFP)採用一套建議演算法(Tonetti & Sanz, 2019),協助臨床醫師為新患者進行牙周診斷流程。該流程包含四個連續步驟:
Identifying a patient suspected of having periodontitis 疑似牙周炎患者的識別
Confirming the diagnosis of periodontitis 牙周炎診斷的確認
Staging the periodontitis case 牙周炎病例的分期
Grading the periodontitis case 牙周炎病例的分級
4.2 | Differential Diagnosis 4.2 | 鑑別診斷
Periodontitis should be differentiated from the following clinical conditions (not an exhaustive list of conditions and diseases): 牙周炎應與以下臨床狀況進行區分(非完整列舉所有狀況與疾病):
Gingivitis (Chapple et al., 2018) 牙齦炎(Chapple 等人,2018 年)
Vertical root fracture (Jepsen et al., 2018) 牙根縱裂(Jepsen 等人,2018 年)
Cervical decay (Jepsen et al., 2018) 牙頸部齲齒(Jepsen 等人,2018 年)
Cemental tears (Jepsen et al., 2018) 牙骨質撕裂(Jepsen 等人,2018 年)
Periodontal abscess (Herrera et al., 2018) 牙周膿腫(Herrera 等人,2018 年)
Necrotizing periodontal diseases (Herrera et al., 2018) 壞死性牙周疾病(Herrera 等人,2018 年)
4.3 | Sequence for the treatment of periodontitis stages I, II and III 4.3 | 第一、二、三期牙周炎治療順序
Patients, once diagnosed, should be treated according to a pre-established stepwise approach to therapy that, depending on the disease stage, should be incremental, each including different interventions. 患者一旦確診後,應根據預先制定的階段性治療方案進行治療,該方案會依據疾病階段逐步加強,每個階段包含不同的介入措施。
An essential prerequisite to therapy is to inform the patient of the diagnosis, including causes of the condition, risk factors, treatment 治療的基本前提是向患者說明診斷結果,包括病症成因、風險因素及治療方式
TABLE 8 Periodontitis grade. Adapted from Papapanou et al. (2018) 表 8 牙周炎分級。改編自 Papapanou 等人(2018)
Periodontitis grade 牙周炎分級
Grade A: Slow rate of progression A 級:進展速度緩慢
Grade B: Moderate rate of progression B 級:進展速度中等
Grade C: Rapid rate of progression C 級:進展速度快速
Primary criteria 主要標準
Direct evidence of progression 進展的直接證據
Longitudinal data (radiographic bone loss or CAL) 縱向數據(放射線骨骼流失或 CAL)
Evidence of no loss over 5 years 5 年內無流失的證據
< 2mm<2 \mathrm{~mm} over 5 years 超過 5 年
>= 2mm\geq 2 \mathrm{~mm} over 5 years 超過 5 年
Indirect evidence of progression 進展的間接證據
% bone loss/age 骨骼流失/年齡
<0.25 《Sanz 2020 - 第一至三期牙周炎治療—EFP S3 級臨床實踐指南》
0.25 to 1.0 0.25 至 1.0
>1.0
Case phenotype 病例表型
Heavy biofilm deposits with low levels of destruction 大量生物膜沉積伴隨輕微破壞
Destruction commensurate with biofilm deposits 破壞程度與生物膜沉積相符
Destruction exceeds expectation given biofilm deposits; specific clinical patterns suggestive of periods of rapid progression and/or early onset disease (e.g., molar/incisor pattern; lack of expected response to standard bacterial control therapies) 破壞程度超出生物膜沉積預期;特定臨床模式顯示快速進展期和/或早發性疾病(例如臼齒/門齒模式;對標準細菌控制療法缺乏預期反應)
Normoglycemic / no diagnosis of diabetes 血糖正常 / 無糖尿病診斷
HbA1c <7.0% in patients with diabetes 糖尿病患者 HbA1c <7.0%
HbA1c >= 7.0%\geq 7.0 \% in patients with diabetes 糖尿病患者的 HbA1c >= 7.0%\geq 7.0 \%
Periodontitis grade Grade A: Slow rate of progression Grade B: Moderate rate of progression Grade C: Rapid rate of progression
Primary criteria Direct evidence of progression Longitudinal data (radiographic bone loss or CAL) Evidence of no loss over 5 years < 2mm over 5 years >= 2mm over 5 years
Indirect evidence of progression % bone loss/age <0.25 0.25 to 1.0 >1.0
Case phenotype Heavy biofilm deposits with low levels of destruction Destruction commensurate with biofilm deposits Destruction exceeds expectation given biofilm deposits; specific clinical patterns suggestive of periods of rapid progression and/or early onset disease (e.g., molar/incisor pattern; lack of expected response to standard bacterial control therapies)
Grade modifiers Risk factors Smoking Non-smoker Smoker <10 cigarettes/day Smoker >= 10 cigarettes/day
Diabetes Normoglycemic / no diagnosis of diabetes HbA1c <7.0% in patients with diabetes HbA1c >= 7.0% in patients with diabetes| Periodontitis grade | | | Grade A: Slow rate of progression | Grade B: Moderate rate of progression | Grade C: Rapid rate of progression |
| :--- | :--- | :--- | :--- | :--- | :--- |
| Primary criteria | Direct evidence of progression | Longitudinal data (radiographic bone loss or CAL) | Evidence of no loss over 5 years | $<2 \mathrm{~mm}$ over 5 years | $\geq 2 \mathrm{~mm}$ over 5 years |
| | Indirect evidence of progression | % bone loss/age | <0.25 | 0.25 to 1.0 | >1.0 |
| | | Case phenotype | Heavy biofilm deposits with low levels of destruction | Destruction commensurate with biofilm deposits | Destruction exceeds expectation given biofilm deposits; specific clinical patterns suggestive of periods of rapid progression and/or early onset disease (e.g., molar/incisor pattern; lack of expected response to standard bacterial control therapies) |
| Grade modifiers | Risk factors | Smoking | Non-smoker | Smoker <10 cigarettes/day | Smoker $\geq 10$ cigarettes/day |
| | | Diabetes | Normoglycemic / no diagnosis of diabetes | HbA1c <7.0% in patients with diabetes | HbA1c $\geq 7.0 \%$ in patients with diabetes |
Grade should be used as an indicator of the rate of periodontitis progression. The primary criteria are either direct or indirect evidence of progression. Whenever available, direct evidence is used; in its absence indirect estimation is made using bone loss as a function of age at the most affected tooth or case presentation (radiographic bone loss expressed as percentage of root length divided by the age of the subject, RBL/age). Clinicians should initially assume Grade B disease and seek specific evidence to shift towards grade A or C , if available. Once grade is established based on evidence of progression, it can be modified based on the presence of risk factors. CAL, clinical attachment loss; HbA1c, glycated hemoglobin A1c; RBL, radiographic bone loss. 應將分級作為牙周炎進展速率的指標。主要判斷標準為直接或間接的疾病進展證據。若有直接證據則優先採用;若無直接證據,則以最嚴重牙齒或病例呈現的年齡相關骨骼流失情況進行間接估算(放射線檢查顯示的骨骼流失程度以牙根長度百分比除以患者年齡表示,即 RBL/年齡)。臨床醫師應先假設為 B 級疾病,若有具體證據則可調整為 A 級或 C 級。一旦根據進展證據確立分級後,可再依據風險因素的存在與否進行調整。CAL:臨床附著喪失;HbA1c:糖化血色素 A1c;RBL:放射線檢查骨骼流失。
alternatives and expected risks and benefits including the option of no treatment. This discussion should be followed by agreement on a personalized care plan. The plan might need to be modified during the treatment journey, depending on patient preferences, clinical findings and changes to overall health. 替代方案及預期風險與效益(包含不治療的選項)。討論後應就個人化照護計畫達成共識。該計畫可能需在治療過程中根據患者偏好、臨床發現及整體健康狀況變化進行調整。
The first step in therapy is aimed at guiding behaviour change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions: 治療的第一步旨在透過激勵患者成功清除牙齦上牙菌斑和控制風險因素來引導行為改變,可能包括以下介入措施:
Supragingival dental biofilm control 牙齦上牙菌斑控制
Interventions to improve the effectiveness of oral hygiene [motivation, instructions (oral hygiene instructions, OHI )] 提升口腔衛生有效性的介入措施[動機激發、指導(口腔衛生指導,OHI)]
Adjunctive therapies for gingival inflammation 針對牙齦發炎的輔助療法
Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as well as possible plaque-retentive factors that impair oral hygiene practices. 專業機械性牙菌斑清除(PMPR),包含旨在清除牙齦上菌斑與牙結石,以及可能妨礙口腔衛生習慣的菌斑滯留因子的專業處置。
Risk factor control, which includes all the health behavioural change interventions eliminating/mitigating the recognized risk factors for periodontitis onset and progression (smoking cessation, improved metabolic control of diabetes, and perhaps physical exercise, dietary counselling and weight loss). 風險因子控制,包含所有能消除/減緩牙周炎發生與進展之已知風險因子的健康行為改變介入措施(戒菸、改善糖尿病代謝控制,以及可能的體能鍛鍊、飲食諮詢與減重)。
This first step of therapy should be implemented in all periodontitis patients, irrespective of the stage of their disease, and should be re-evaluated frequently in order to 此治療第一階段應適用於所有牙周炎患者,無論其疾病分期為何,且需頻繁重新評估以
Continue to build motivation and adherence, or explore other alternatives to overcome the barriers 持續建立動機與遵從性,或探索其他替代方案來克服障礙
Develop skills in dental biofilm removal and modify as required 培養牙菌斑清除技能並視需要調整
Allow for the appropriate response of the ensuing steps of therapy 為後續治療步驟的適當反應預留空間
The second step of therapy (cause-related therapy) is aimed at controlling (reducing/eliminating) the subgingival biofilm and calculus (subgingival instrumentation). In addition to this, the following interventions may be included: 治療的第二階段(病因相關治療)旨在控制(減少/消除)牙齦下菌斑和牙結石(牙齦下器械處理)。除此之外,可能還包括以下介入措施:
Use of adjunctive physical or chemical agents 使用輔助性物理或化學藥劑
Use of adjunctive host-modulating agents (local or systemic) 使用輔助性宿主調節劑(局部或全身)
Use of adjunctive subgingival locally delivered antimicrobials 使用輔助性牙齦下局部投藥抗菌劑
Use of adjunctive systemic antimicrobials 使用輔助性全身抗菌劑
This second step of therapy should be used for all periodontitis patients, irrespective of their disease stage, only in teeth with loss of periodontal support and/or periodontal pocket formation*. 此治療第二步驟應適用於所有牙周炎患者,不論其疾病階段為何,僅適用於有牙周支持組織喪失及/或牙周囊袋形成*的牙齒。
*In specific clinical situations, such as in the presence of deep probing depths, first and second steps of therapy could be delivered simultaneously (such as for preventing periodontal abscess development). 在特定臨床情況下,例如存在深層探測深度時,治療的第一和第二階段可同時進行(例如為預防牙周膿腫形成)。
The individual response to the second step of therapy should be assessed once the periodontal tissues have healed (periodontal re-evaluation). If the endpoints of therapy (no periodontal pockets > 4mm>4 \mathrm{~mm} with bleeding on probing or no deep periodontal pockets [ >= 6mm][\geq 6 \mathrm{~mm}] ) have not been achieved, the third step of therapy should 當牙周組織癒合後(牙周再評估),應評估患者對第二階段治療的個別反應。若未達到治療終點(無探測出血的牙周囊袋 > 4mm>4 \mathrm{~mm} 或無深層牙周囊袋 [ >= 6mm][\geq 6 \mathrm{~mm}] ),則應考慮
be considered. If the treatment has been successful in achieving the endpoints of therapy, patients should be placed in a supportive periodontal care (SPC) programme. 進行第三階段治療。若治療已成功達成終點目標,患者應進入支持性牙周照護(SPC)計畫。
3. The third step of therapy is aimed at treating those areas of the dentition non-responding adequately to the second step of therapy (presence of pockets >= 4mm\geq 4 \mathrm{~mm} with bleeding on probing or presence of deep periodontal pockets [ >= 6mm\geq 6 \mathrm{~mm} ]), with the purpose of gaining further access to subgingival instrumentation, or aiming at regenerating or resecting those lesions that add complexity in the management of periodontitis (intra-bony and furcation lesions). 3. 第三階段治療旨在處理對第二階段治療反應不佳的齒列區域(存在探測出血的牙周囊袋 >= 4mm\geq 4 \mathrm{~mm} 或深層牙周囊袋[ >= 6mm\geq 6 \mathrm{~mm} ]),目的在於進一步進行齦下器械處理,或針對增加牙周炎治療複雜度的病灶(骨內缺損和分叉病灶)進行再生或切除治療。
It may include the following interventions: 可能包含以下介入措施:
Repeated subgingival instrumentation with or without adjunctive therapies 重複進行牙齦下刮治,可搭配輔助療法或單獨施行
Access flap periodontal surgery 牙周翻瓣手術
Resective periodontal surgery 牙周切除性手術
Regenerative periodontal surgery 牙周再生手術
When there is indication for surgical interventions, these should be subject to an additional patient consent and specific evaluation of risk factors or medical contra-indications should be considered. 當有手術介入的適應症時,應取得患者額外同意,並特別評估風險因素或醫療禁忌症。
The individual response to the third step of therapy should be re-assessed (periodontal re-evaluation) and ideally the endpoints of therapy should be achieved, and patients should be placed in supportive periodontal care, although these endpoints of therapy may not be achievable in all teeth in severe Stage III periodontitis patients. 應重新評估患者對第三階段治療的個體反應(牙周再評估),理想情況下應達成治療終點,並將患者納入支持性牙周照護,儘管在嚴重的第三期牙周炎患者中,並非所有牙齒都能達到這些治療終點。
4. Supportive periodontal care is aimed at maintaining periodontal stability in all treated periodontitis patients combining preventive and therapeutic interventions defined in the first and second steps of therapy, depending on the gingival and periodontal status of the patient’s dentition. This step should be rendered at regular intervals according to the patient’s needs, and in any of these recall visits, any patient may need re-treatment if recurrent disease is detected, and in these situations, a proper diagnosis and treatment plan should be reinstituted. In addition, compliance with the recommended oral hygiene regimens and healthy lifestyles are part of supportive periodontal care. 4. 支持性牙周照護旨在透過結合治療第一階段與第二階段所定義的預防性和治療性介入措施,根據患者牙列的牙齦與牙周狀況,維持所有接受治療的牙周炎患者的牙周穩定性。此階段應根據患者需求定期進行,在每次回診檢查中,若發現疾病復發,任何患者都可能需要重新治療,此時應重新制定適當的診斷與治療計畫。此外,遵守建議的口腔衛生習慣與健康生活方式也是支持性牙周照護的一部分。
In any of the steps of therapy, tooth extraction may be considered if the affected teeth are considered with a hopeless prognosis. 在治療的任何階段,若受影響牙齒被判定預後不良,可考慮進行拔牙。
The first part of this document was prepared by the steering group with the help of the methodology consultants, and it was carefully examined by the experts participating in the consensus and was voted upon in the initial plenary session to form the basis for the specific recommendations. 本文件的第一部分由指導小組在方法學顧問的協助下完成,並經參與共識的專家仔細審查,在首次全體會議中進行表決,形成具體建議的基礎。
Strength of consensus strong consensus (0% of the group abstained due to potential Col). 共識強度:強烈共識(0%的成員因潛在利益衝突而棄權)。
5 | CLINICAL RECOMMENDATIONS: FIRST STEP OF THERAPY 5 | 臨床建議:治療第一階段
The first step of therapy is aimed at providing the periodontitis patient with the adequate preventive and health promotion tools to facilitate his/her compliance with the prescribed therapy and the 治療第一階段旨在為牙周炎患者提供適當的預防和健康促進工具,以促進其對處方治療的配合度與
assurance of adequate outcomes. This step not only includes the implementation of patient’s motivation and behavioural changes to achieve adequate self-performed oral hygiene practices, but also the control of local and systemic modifiable risk factors that significantly influence this disease. Although this first step of therapy is insufficient to treat a periodontitis patient, it represents the foundation for optimal treatment response and long-term stable outcomes. 確保達到足夠的治療效果。此步驟不僅包括實施患者的動機與行為改變以達成適當的自我口腔衛生習慣,還需控制會顯著影響此疾病的局部與全身可調節風險因子。雖然這第一階段的治療不足以完全治癒牙周炎患者,但它代表著獲得最佳治療反應與長期穩定療效的基礎。
This first step includes not only the educational and preventive interventions aimed to control gingival inflammation but also thevprofessional mechanical removal of the supragingival plaque and calculus, together with the elimination local retentive factors. 這第一階段不僅包括旨在控制牙齦發炎的教育與預防性介入措施,還包含專業機械式去除齦上牙菌斑與牙結石,同時消除局部滯留因子。
5.1 | Intervention: Supragingival dental biofilm control (by the patient) 5.1 | 介入措施:齦上牙菌斑控制(由患者執行)
R.1.1 | What are the adequate oral hygiene practices of periodontitis patients in the different steps of periodontitis therapy? R.1.1 | 在牙周炎治療的不同階段中,患者應遵循哪些適當的口腔衛生習慣?
We recommend that the same guidance on oral hygiene practices to control gingival inflammation is enforced throughout all the steps of periodontal therapy including supportive periodontal care. 我們建議在牙周治療的所有階段,包括支持性牙周照護,都應實施相同的口腔衛生指導以控制牙齦發炎。
Supporting literature Van der Weijden and Slot (2015) 支持文獻 Van der Weijden 和 Slot (2015)
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 建議等級 Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Strong consensus [3.8% of the group abstained due to potential conflict of interest (Col)] 共識強度 強烈共識 [3.8%的成員因潛在利益衝突(Col)而棄權]
Background 背景
Intervention 介入措施
Supragingival dental biofilm control can be achieved by mechanical and chemical means. Mechanical plaque control is mainly performed by tooth brushing, either with manual or powered toothbrushes or with supplemental interdental cleaning using dental floss, interdental brushes, oral irrigators, wood sticks, etc. As adjuncts to mechanical plaque control, antiseptic agents, delivered in different formats, such as dentifrices and mouth rinses have been recommended. Furthermore, other agents aimed to reduce gingival inflammation have also been used adjunctively to mechanical biofilm control, such as probiotics, anti-inflammatory agents and antioxidant micronutrients. 齒齦上牙菌斑控制可透過機械與化學方式達成。機械式牙菌斑控制主要透過刷牙進行,可使用手動或電動牙刷,並輔以牙線、齒間刷、口腔沖洗器、木棒等進行齒間清潔。作為機械式牙菌斑控制的輔助手段,建議使用不同劑型的抗菌劑,如牙膏與漱口水。此外,其他旨在減少牙齦發炎的輔助劑也常與機械式生物膜控制併用,例如益生菌、消炎藥及抗氧化微量營養素。
Available evidence 現有證據
Even though oral hygiene interventions and other preventive measurements for gingivitis control were not specifically addressed in the systematic reviews prepared for this Workshop to Develop Guidelines for the treatment of periodontitis, evidence can be drawn from the XI European Workshop in Periodontology (2014) (Chapple et al., 2015) and the systematic review on oral hygiene practices for the prevention and treatment of gingivitis (Van der Weijden & Slot, 2015). This available evidence supports the following: 儘管本次制定牙周炎治療指南的研討會所準備的系統性文獻回顧中,並未特別針對控制牙齦炎的口腔衛生介入措施與其他預防性措施進行探討,但可參考第十一屆歐洲牙周病學研討會(2014 年)(Chapple 等人,2015 年)以及關於預防和治療牙齦炎的口腔衛生實踐之系統性文獻回顧(Van der Weijden & Slot,2015 年)所提出的證據。這些現有證據支持以下結論:
Professional oral hygiene instructions (OHI) should be provided to reduce plaque and gingivitis. Re-enforcement of OHI may provide additional benefits. 應提供專業口腔衛生指導(OHI)以減少牙菌斑和牙齦炎。加強口腔衛生指導可能帶來額外益處。
Manual or power tooth brushing are recommended as a primary means of reducing plaque and gingivitis. The benefits of tooth brushing out-weigh any potential risks. 建議以手動或電動牙刷作為減少牙菌斑和牙齦炎的主要方式。刷牙所帶來的好處遠超過任何潛在風險。
When gingival inflammation is present, inter-dental cleaning, preferably with interdental brushes (IDBs) should be professionally taught to patients. Clinicians may suggest other inter-dental cleaning devices/methods when the use of IDBs is not appropriate. 當牙齦出現發炎時,應由專業人員教導患者使用牙間刷(IDBs)進行齒縫清潔。若牙間刷不適用時,臨床醫師可建議其他齒縫清潔工具或方法。
R.1.2 | Are additional strategies in motivation useful? R.1.2 | 額外的激勵策略是否有助益?
We recommend emphasizing the importance of oral hygiene and engaging the periodontitis patient in behavioural change for oral hygiene improvement. 我們建議強調口腔衛生的重要性,並促使牙周炎患者改變行為以改善口腔衛生。
Supporting literature Carra et al. (2020) 支持文獻 Carra 等人(2020 年)
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 推薦等級 A 級 - uarr uarr\uparrow \uparrow
Strength of consensus Strong consensus (1.3% of the group abstained due to potential Col) 共識強度 強烈共識(1.3%的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Oral hygiene instructions (OHI) and patient motivation in oral hygiene practices should be an integral part of the patient management during all stages of periodontal treatment (Tonetti et al., 2015). Different behavioural interventions, as well as communication and educational methods, have been proposed to improve and maintain the patient’s plaque control over time (Sanz & Meyle, 2010). See additional information in the next section on “Methods of motivation.” 口腔衛生指導(OHI)與患者口腔衛生習慣的動機激勵,應作為牙周治療所有階段中患者管理的重要組成部分(Tonetti 等人,2015 年)。為持續改善並維持患者的牙菌斑控制,已提出多種行為介入措施,以及溝通與教育方法(Sanz & Meyle,2010 年)。更多資訊請參閱下一節「動機激勵方法」。
R.1.3 | Are psychological methods for motivation effective to improve the patient’s compliance in oral hygiene practices? R.1.3 | 心理激勵方法是否能有效提升患者對口腔衛生習慣的合規性?
Evidence-based statement (1.3) 實證聲明(1.3)
To improve patient’s behaviour towards compliance with oral hygiene practices, psychological methods such as motivational interviewing or cognitive behavioural therapy have not shown a significant impact. 為提升患者對口腔衛生習慣的配合度,採用動機式訪談或認知行為治療等心理學方法並未顯示顯著效果。
Supporting literature Carra et al. (2020) 支持文獻 Carra 等人(2020)
Quality of evidence Five randomized clinical trials (RCTs) (1716 subjects) with duration >= 6\geq 6 months in untreated periodontitis patients [(4 RCTs with high and 1 RCT with low risk of bias (RoB)] 證據品質 針對未治療牙周炎患者進行的五項隨機臨床試驗(RCTs)(1716 名受試者),研究期間 >= 6\geq 6 個月[(4 項 RCTs 具高偏誤風險,1 項 RCT 具低偏誤風險(RoB)]
Grade of recommendation Statement-unclear, additional research needed 建議等級 聲明不明確,需進一步研究
Evidence-based statement (1.3) 實證聲明 (1.3)
Strength of consensus Strong consensus (1.3% of the group abstained due to potential Col) 共識強度 強烈共識 (1.3%的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Several different psychological interventions based on social cognitive theories, behavioural principles and motivational interviewing (MI) have been applied to improve OHI adherence in patients with periodontal diseases. The available evidence has not demonstrated that these psychological interventions based on cognitive constructs and motivational interviewing principles provided by oral health professionals have improved the patient’s oral hygiene performance as measured by the reduction of plaque and bleeding scores over time. 基於社會認知理論、行為原則和動機式訪談(MI)的多種心理介入措施,已被應用於改善牙周病患者的口腔衛生指導遵從性。現有證據尚未證明,由口腔健康專業人員提供的這些基於認知建構和動機式訪談原則的心理介入,能隨著時間推移透過降低菌斑指數和出血指數來改善患者的口腔衛生表現。
Available evidence 現有證據
The evidence includes two RCTs on MI (199 patients) and three RCTs on psychological interventions based on social cognitive theories and feedback (1,517 patients). 證據包含兩項關於動機式訪談的隨機對照試驗(199 名患者)和三項基於社會認知理論與回饋的心理介入隨機對照試驗(1,517 名患者)。
Risk of bias 偏誤風險
The overall body of evidence was assessed at high risk of bias (four RCTs high and one RCT low). 整體證據品質評估為高偏誤風險(四項隨機對照試驗為高風險,一項為低風險)。
Consistency 一致性
The majority of the studies found no significant additional benefit implementing psychological interventions in conjunction with OHI . 多數研究發現,在口腔衛生指導之外實施心理介入並未帶來顯著額外效益。
Clinical relevance and effect size 臨床相關性與效應量
The reported effect size was not considered clinically relevant. 所報告的效應量未被認為具有臨床相關性。
Balance of benefit and harm 效益與風險的平衡
Benefit and harm were not reported, and due to the fact that different health professionals were involved to provide interventions, no conclusion could be drawn. 未報告效益與風險,且由於由不同醫療專業人員提供介入措施,因此無法得出結論。
Economic considerations 經濟考量
These studies did not assess a cost-benefit evaluation in spite of the expected additional cost related to the psychological intervention. 儘管心理介入預期會增加額外成本,但這些研究並未進行成本效益評估。
Patient preferences 病患偏好
No proper information was available to assess this issue. 缺乏足夠資訊來評估此議題。
Applicability 適用性
A psychological approach needs special training to be effectively performed. 心理學方法需要特殊訓練才能有效執行。
Adjunctive therapies for gingival inflammation have been considered within the adjunctive therapies to subgingival debridement, and therefore, they have been evaluated within the second step of therapy. 牙齦發炎的輔助療法已被納入次齦下刮治的輔助治療中,因此這些療法已在治療的第二階段進行評估。
R1.4 | What is the efficacy of supragingival professional mechanical plaque removal (PMPR) and control of retentive factors in periodontitis therapy? R1.4 | 在牙周炎治療中,專業性機械式牙菌斑清除(PMPR)與滯留因子控制的療效為何?
We recommend supragingival professional mechanical plaque removal (PMPR) and control of retentive factors, as part of the first step of therapy. 我們建議將專業性機械式牙菌斑清除(PMPR)與滯留因子控制作為治療第一階段的一部分。
Supporting literature Needleman, Nibali, and Di Iorio (2015); Trombelli, Franceschetti, and Farina (2015) 支持文獻 Needleman、Nibali 和 Di Iorio(2015);Trombelli、Franceschetti 和 Farina(2015)
Strength of consensus Unanimous consensus (0% of the group abstained due to potential Col) 共識強度 全體一致共識(0%小組成員因潛在利益衝突棄權)
Expert consensus-based recommendation (1.4)
We recommend supragingival professional mechanical plaque removal (PMPR) and control of retentive factors, as part of the first step of therapy.
Supporting literature Needleman, Nibali, and Di Iorio (2015); Trombelli, Franceschetti, and Farina (2015)
Grade of recommendation Grade A- uarr uarr
Strength of consensus Unanimous consensus (0% of the group abstained due to potential Col)| Expert consensus-based recommendation (1.4) |
| :--- |
| We recommend supragingival professional mechanical plaque removal (PMPR) and control of retentive factors, as part of the first step of therapy. |
| Supporting literature Needleman, Nibali, and Di Iorio (2015); Trombelli, Franceschetti, and Farina (2015) |
| Grade of recommendation Grade A- $\uparrow \uparrow$ |
| Strength of consensus Unanimous consensus (0% of the group abstained due to potential Col) |
Background 背景
Intervention 介入措施
The removal of the supragingival dental biofilm and calcified deposits (calculus) (here identified under the term “professional mechanical plaque removal” (PMPR) is considered an essential component in the primary (Chapple et al., 2018) and secondary (Sanz et al., 2015) prevention of periodontitis as well as within the basic treatment of plaque-induced periodontal diseases (van der Weijden & Slot, 2011). Since the presence of retentive factors, either associated with the tooth anatomy or more frequently, due to inadequate restorative margins, are often associated with gingival inflammation and/or periodontal attachment loss, they should be prevented/eliminated to reduce their impact on periodontal health. 清除牙齦上的牙菌斑和鈣化沉積物(牙結石)(此處以「專業機械性牙菌斑清除術」(PMPR)一詞指稱),被視為牙周病初級(Chapple 等人,2018 年)與次級預防(Sanz 等人,2015 年)的關鍵要素,同時也是牙菌斑誘發牙周疾病基礎治療的重要環節(van der Weijden & Slot,2011 年)。由於滯留因素(無論是與牙齒解剖結構相關,或更常見於修復體邊緣不當)常導致牙齦發炎及/或牙周附連喪失,應予以預防或消除以降低其對牙周健康的影響。
Available evidence 現有證據
Even though these interventions were not specifically addressed in the systematic reviews prepared for this Workshop to develop guidelines for the treatment of periodontitis, indirect evidence can be found in the 2014 European Workshop on Prevention, in which the role of PMPR was addressed both in primary prevention (Needleman et al., 2015) or in supportive periodontal care (SPC) (Trombelli et al., 2015). Some additional evidence can be found to support both procedures, as part of periodontitis therapy. A split-mouth RCT, with a follow-up of 450 days in 25 subjects, concluded that the performance of supragingival debridement, before 儘管這些介入措施並未在本次為制定牙周炎治療指南而籌備的系統性回顧中特別提及,但我們可從 2014 年歐洲預防研討會中找到間接證據,該研討會同時探討了專業機械牙菌斑清除(PMPR)在初級預防(Needleman 等人,2015 年)與支持性牙周照護(SPC)(Trombelli 等人,2015 年)中所扮演的角色。另有部分證據支持將這兩項程序作為牙周炎治療的組成部分。一項針對 25 名受試者進行 450 天追蹤的分口隨機對照試驗得出結論:在進行
subgingival debridement, decreased subgingival treatment needs and maintained the periodontal stability over time (Gomes, Romagna, Rossi, Corvello, & Angst, 2014). In addition, supragingival debridement may induce beneficial changes in the subgingival microbiota (Ximénez-Fyvie et al., 2000). Moreover, it has been established that retentive factors may increase the risk of worsening the periodontal condition (Broadbent, Williams, Thomson, & Williams, 2006; Demarco et al., 2013; Lang, Kiel, & Anderhalden, 1983). 牙齦下清創、降低牙齦下治療需求並長期維持牙周穩定性(Gomes, Romagna, Rossi, Corvello, & Angst, 2014)。此外,牙齦上清創可能誘導牙齦下微生物群產生有益變化(Ximénez-Fyvie et al., 2000)。再者,已有研究證實滯留因子可能增加牙周狀況惡化的風險(Broadbent, Williams, Thomson, & Williams, 2006; Demarco et al., 2013; Lang, Kiel, & Anderhalden, 1983)。
5.4 | Intervention: Risk factor control 5.4 | 介入措施:風險因子控制
R1.5 | What is the efficacy of risk factor control in periodontitis therapy? R1.5 | 牙周炎治療中風險因子控制的成效為何?
Evidence-based recommendation (1.5) 實證基礎建議 (1.5)
We recommend risk factor control interventions in periodontitis patients, as part of the first step of therapy. 我們建議將風險因子控制介入措施納入牙周炎患者的治療第一步驟。
Supporting literature Ramseier et al. (2020) 參考文獻 Ramseier et al. (2020)
Quality of evidence 25 clinical studies 證據品質 25 項臨床研究
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 建議等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Strong consensus (1.3% of the group abstained due to potential Col) 共識強度 強烈共識(1.3%的成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
Smoking and diabetes are two proven risk factors in the etiopathogenesis of periodontitis (Papapanou et al., 2018), and therefore, their control should be an integral component in the treatment of these patients. Interventions for risk factor control have aimed to educate and advice patients for behavioural change aimed to reduce them and in specific cases to refer them for adequate medical therapy. Other relevant factors associated with healthy lifestyles (stress reduction, dietary counselling, weight loss or increased physical activities) may also be part of the overall strategy for reducing patient’s risk factors. 吸菸與糖尿病是牙周炎發病機制中已證實的兩大風險因子(Papapanou et al., 2018),因此控制這些風險因子應成為此類患者治療的重要組成部分。針對風險因子控制的介入措施,旨在透過教育與建議促使患者改變行為以降低風險,並在特定情況下轉介患者接受適當的醫療處置。其他與健康生活方式相關的因素(如壓力管理、飲食諮詢、減重或增加體能活動)亦可納入降低患者風險因子的整體策略。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), the authors have identified 13 relevant guidelines for interventions for tobacco smoking cessation, promotion of diabetes control, physical exercise (activity), change of diet, carbohydrate (dietary sugar reduction) and weight loss. In addition, 25 clinical studies were found that assess the impact of (some of) these interventions in gingivitis/periodontitis patients. 在系統性文獻回顧中(Ramseier et al., 2020),作者共識別出 13 項相關臨床指引,內容涵蓋戒菸介入、糖尿病控制促進、體能鍛鍊(活動)、飲食調整、碳水化合物控制(減少飲食糖分攝取)及減重措施。此外,研究發現 25 項臨床試驗評估了(部分)這些介入措施對牙齦炎/牙周炎患者的影響。
Risk of bias 偏誤風險
It is explained specifically for each intervention. 針對每項介入措施皆有具體說明。
Consistency 一致性
The heterogeneity in study design precludes more consistent findings, but adequate consistency may be found for studies on smoking cessation and diabetes control. 研究設計的異質性導致難以獲得較一致的結果,但在戒菸與糖尿病控制的研究中可發現足夠的一致性。
Clinical relevance and effect size 臨床相關性與效應量
No meta-analysis was performed; effect sizes can be found in the individual studies. 未進行統合分析;效應量可於各項研究中查閱。
Balance of benefit and harm 利益與風險的平衡
In addition to periodontal benefits, all the tested interventions represent a relevant beneficial health impact. 除了牙周方面的益處外,所有測試的干預措施都代表著相關的健康效益。
Economic considerations 經濟考量
The various studies do not indicate a cost-benefit evaluation. However, it cannot be discarded an additional cost related to the psychological intervention. However, the systemic health benefits that can be obtained from these interventions, if they are successful, would represent reduced cost of healthcare services in different comorbidities. 各項研究並未顯示成本效益評估。然而,心理介入相關的額外成本不可忽視。不過,若這些干預措施成功實施,其所帶來的全身健康效益將可降低多種共病症的醫療服務成本。
Patient preferences 病患偏好
Interventions are heterogeneous, but the potential systemic health benefits may favour preference for them. 治療方式各異,但潛在的全身健康益處可能使其更受青睞。
Applicability 適用性
Demonstrated with studies testing large groups from the general population; the practicality of routine use is still to be demonstrated. 已透過針對一般大群體的研究驗證;但常規使用的實用性仍有待證實。
R1.6 | What is the efficacy of tobacco smoking cessation interventions in periodontitis therapy? R1.6 | 在牙周炎治療中,戒菸介入措施的效果如何?
Evidence-based recommendation (1.6) 實證基礎建議 (1.6)
We recommend tobacco smoking cessation interventions to be implemented in patients undergoing periodontitis therapy. 我們建議在進行牙周炎治療的患者中實施戒菸介入措施。
Supporting literature Ramseier et al. (2020) 參考文獻 Ramseier et al. (2020)
Quality of evidence Six prospective studies with, at least, 6-month follow-up 證據品質 六項前瞻性研究,至少追蹤六個月
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 建議等級 A 級建議 uarr uarr\uparrow \uparrow
Strength of consensus Unanimous consensus (1.2% of the group abstained due to potential Col) 共識強度 全體一致共識(1.2%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
Periodontitis patients may benefit from smoking cessation interventions to improve periodontal treatment outcomes and the maintenance of periodontal stability. Interventions consist of brief counselling and may include patient referral for advanced counselling and pharmacotherapy. 牙周炎患者可透過戒菸介入措施改善牙周治療效果並維持牙周穩定性。介入措施包含簡短諮詢,並可能包含轉介患者接受進階諮詢與藥物治療。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), six prospective studies of 6- to 24-month duration and performed at university setting were identified. Different interventions were tested (smoking cessation counselling, 5 A’s [ask, advise, assess, assist, and arrange], cognitive behavioural therapy [CBT], motivational interview, brief interventions, 系統性文獻回顧(Ramseier 等人,2020 年)中確認了六項在大學環境進行、為期 6 至 24 個月的前瞻性研究。測試了不同介入措施(戒菸諮詢、5A 法[詢問、建議、評估、協助與安排]、認知行為治療[CBT]、動機式訪談、簡短介入措施)。
nicotine replacement therapies). In three of the studies, the intervention was programmed in parallel with non-surgical periodontal therapy (NSPT) and followed by SPC, in one study SPC patients were included and, in another, patients in NSPT and in SPC were compared; in one study, it was unclear. The success of smoking cessation was considered as moderate ( 4%-30%4 \%-30 \% after 1-2 years), except in one study. Two studies demonstrated benefits in periodontal outcomes, when comparing former smokers to smokers and oscillators. 尼古丁替代療法)。在三項研究中,干預措施與非手術性牙周治療(NSPT)同步進行,並後續接受支持性牙周照護(SPC);其中一項研究納入了 SPC 患者,另一項則比較了 NSPT 與 SPC 患者;還有一項研究情況不明。除一項研究外,戒菸成功率被認為中等(1-2 年後 4%-30%4 \%-30 \% )。兩項研究顯示,當比較已戒菸者與持續吸菸及搖擺不定者時,牙周治療結果有所改善。
Additional factors have been discussed in the overall evaluation of risk factor control. 在風險因子控制的整體評估中,已討論了其他相關因素。
R1.7 | What is the efficacy of promotion of diabetes control interventions in periodontitis therapy? R1.7 | 促進糖尿病控制介入措施對牙周炎治療有何成效?
Evidence-based recommendation (1.7) 實證建議(1.7)
We recommend diabetes control interventions in patients undergoing periodontitis therapy. 我們建議在進行牙周炎治療的患者中實施糖尿病控制措施。
Supporting literature Ramseier et al. (2020) 支持文獻 Ramseier 等人 (2020)
Quality of evidence Two 6-month RCTs 證據品質 兩項為期 6 個月的隨機對照試驗
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 推薦等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 共識(0%的組員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Periodontitis patients may benefit from diabetes control interventions to improve periodontal treatment outcomes and the maintenance of periodontal stability. These interventions consist of patient education as well as brief dietary counselling and, in situations of hyperglycaemia, the patient’s referral for glycaemic control. 牙周炎患者可透過糖尿病控制介入措施來改善牙周治療效果及維持牙周穩定性。這些介入措施包含病患衛教、簡短飲食諮詢,以及在出現高血糖狀況時轉介患者進行血糖控制。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), two studies on the impact of diabetes control interventions in periodontitis patients were identified, two of them 6-month RCTs, all of them performed at university settings. Periodontal interventions were not clearly defined. Different interventions were tested, including individual lifestyle counselling, dietary changes and oral health education. Some improvements were observed in the intervention groups, in terms of periodontal outcomes. 在系統性文獻回顧(Ramseier 等人,2020 年)中,共發現兩篇關於糖尿病控制介入對牙周炎患者影響的研究,其中兩項為期 6 個月的隨機對照試驗,所有研究皆在大學環境中進行。牙周介入措施未明確定義。測試了多種介入方式,包括個人生活方式諮詢、飲食改變和口腔健康教育。在介入組中觀察到牙周狀況的某些改善。
Additional factors have been discussed in the overall evaluation of risk factor control. 在風險因素控制的整體評估中,還討論了其他因素。
R1.8 | What is the efficacy of increasing physical exercise (activity) in periodontitis therapy? R1.8 | 增加體能鍛煉(活動)在牙周炎治療中的效果如何?
Evidence-based recommendation (1.8) 實證建議(1.8)
We do not know whether interventions aimed to increasing the physical exercise (activity) have a positive impact in periodontitis therapy. 我們尚不清楚旨在增加體能鍛鍊(活動)的干預措施是否對牙周炎治療有正面影響。
Evidence-based recommendation (1.8) 實證基礎建議 (1.8)
Supporting literature Ramseier et al. (2020) 支持文獻 Ramseier 等人 (2020)
Quality of evidence One 12-week RCT, one 12-week prospective study 證據品質 一項 12 週隨機對照試驗,一項 12 週前瞻性研究
Grade of recommendation Grade 0-Statement: unclear, additional research needed 建議等級 等級 0-聲明:尚不明確,需進一步研究
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 共識(0%的組員因潛在利益衝突而棄權)
Evidence-based recommendation (1.8)
Supporting literature Ramseier et al. (2020)
Quality of evidence One 12-week RCT, one 12-week prospective study
Grade of recommendation Grade 0-Statement: unclear, additional research needed
Strength of consensus Consensus (0% of the group abstained due to potential Col)| Evidence-based recommendation (1.8) |
| :--- |
| Supporting literature Ramseier et al. (2020) |
| Quality of evidence One 12-week RCT, one 12-week prospective study |
| Grade of recommendation Grade 0-Statement: unclear, additional research needed |
| Strength of consensus Consensus (0% of the group abstained due to potential Col) |
Background 背景
Intervention 介入措施
Overall evidence from the medical literature suggests that the promotion of physical exercise (activity) interventions may improve both treatment and the long-term management of chronic non-communicable diseases. In periodontitis patients, the promotion may consist of patient education and counselling tailored to the patients’ age and general health. 根據醫學文獻的整體證據顯示,推廣運動(活動)介入措施可能有助於改善慢性非傳染性疾病的治療與長期管理。對於牙周炎患者,這項推廣可包含根據患者年齡與整體健康狀況量身訂做的衛教與諮詢。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), two 12-week studies on the impact of physical exercise (activity) interventions in periodontitis patients were identified, one RCT (testing education with comprehensive yogic interventions followed by yoga exercises) and one prospective study (with briefing followed by physical exercises; the control group was a dietary intervention), performed at university settings. Periodontal interventions were not clearly defined, although in the yoga study, standard therapy was delivered (by not described) in periodontitis patients, while no periodontal therapy was provided in the second study. Both studies reported improved periodontal parameters, including bleeding scores and probing depth changes, after 12 weeks (although in the yoga study also, the influence on psychological stress could not be discarded). 在系統性文獻回顧(Ramseier 等人,2020 年)中,確定了兩項為期 12 週關於運動(活動)介入對牙周炎患者影響的研究,一項為隨機對照試驗(測試綜合瑜伽介入教育後進行瑜伽練習),另一項為前瞻性研究(進行簡報後實施體能鍛鍊;對照組採用飲食介入),這些研究均在大學環境中進行。雖然瑜伽研究中對牙周炎患者實施了標準治療(但未具體描述),而第二項研究則未提供牙周治療,但牙周介入措施並未明確定義。兩項研究均報告在 12 週後改善了牙周參數,包括出血指數和探測深度變化(儘管在瑜伽研究中,心理壓力的影響也無法排除)。
Additional factors have been discussed in the overall evaluation of risk factor control. 在風險因子控制的整體評估中,已討論了其他因素。
R1.9 | What is the efficacy of dietary counselling in periodontitis therapy? R1.9 | 飲食諮詢在牙周炎治療中的效果如何?
Evidence-based recommendation (1.9) 實證基礎建議(1.9)
We do not know whether dietary counselling may have a positive impact in periodontitis therapy. 我們不確定飲食諮詢是否對牙周炎治療有正面影響。
Supporting literature Ramseier et al. (2020) 支持文獻 Ramseier 等人 (2020)
Quality of evidence Three RCTs, four prospective studies 證據品質 三項隨機對照試驗、四項前瞻性研究
Grade of recommendation Grade 0-Statement: unclear, additional research needed 推薦等級 0 級聲明:尚不明確,需進一步研究
Strength of consensus Consensus ( 0%0 \% of the group abstained due to potential Col) 共識強度 共識( 0%0 \% 的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Periodontitis patients may benefit from dietary counselling interventions to improve periodontal treatment outcomes and the maintenance of periodontal stability. These interventions may consist of patient education including brief dietary advices and in specific cases patient’s referral to a nutrition specialist. 牙周炎患者可受益於飲食諮詢介入措施,以改善牙周治療效果並維持牙周穩定性。這些介入措施可能包括患者教育(含簡短飲食建議),以及在特定情況下將患者轉介至營養專科醫師。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), seven studies on the impact of dietary counselling (mainly addressing lower fat intake, less free sugars and salt intake, increase in fruit and vegetable intake) in periodontitis (with or without other comorbidities) patients were identified: three RCTs ( 6 months, 8 weeks, 4 weeks) and four prospective studies ( 12 months, 24 weeks, 12 weeks, 4 weeks), performed at hospital and university settings. Periodontal interventions were not clearly defined, although in the 6-month RCT, periodontal treatment was part of the protocol. Some studies showed significant improvements in periodontal parameters, but the RCT with the longest follow-up was not able to identify significant benefits (Zare Javid, Seal, Heasman, & Moynihan, 2014). 在系統性文獻回顧(Ramseier 等人,2020 年)中,共識別出七項關於飲食諮詢(主要針對降低脂肪攝取、減少游離糖與鹽分攝取、增加蔬果攝取)對牙周炎患者(無論是否合併其他共病症)影響的研究:包含三項隨機對照試驗(6 個月、8 週、4 週)與四項前瞻性研究(12 個月、24 週、12 週、4 週),這些研究均在醫院與大學環境中進行。雖然在為期 6 個月的隨機對照試驗中,牙周治療被納入研究方案,但多數研究的牙周介入措施並未明確定義。部分研究顯示牙周參數有顯著改善,但追蹤期最長的隨機對照試驗卻未能證實顯著效益(Zare Javid, Seal, Heasman, & Moynihan, 2014 年)。
In the systematic review (Ramseier et al., 2020), two studies specifically on the impact of dietary counselling aiming at carbohydrate (free sugars) reduction in gingivitis/periodontitis patients were identified, one 4-week RCT (including also gingivitis patients) and one 24 -week prospective study. Periodontal interventions were not clearly defined. Both studies reported improved gingival indices. 在系統性文獻回顧(Ramseier 等人,2020 年)中,確認有兩項專門針對牙齦炎/牙周炎患者實施減少碳水化合物(游離糖)攝取之飲食諮詢影響的研究,其中包含一項為期 4 週的隨機對照試驗(同時納入牙齦炎患者)與一項 24 週的前瞻性研究。這些研究未明確定義牙周介入措施,但兩項研究均報告牙齦指數獲得改善。
Additional factors have been discussed in the overall evaluation of risk factor control. 在風險因子控制的整體評估中,已討論其他相關因素。
R1.10 | What is the efficacy of lifestyle modifications aiming at weight loss in periodontitis therapy? R1.10 | 減重為目標的生活方式調整在牙周炎治療中的效果為何?
Evidence-based recommendation (1.10) 實證建議(1.10)
We do not know whether interventions aimed to weight loss through lifestyle modification may have a positive impact in periodontitis therapy. 我們尚不清楚透過生活方式調整來減重的干預措施是否對牙周炎治療有正面影響。
Supporting literature Ramseier et al. (2020) 支持文獻 Ramseier 等人 (2020)
Quality of evidence Five prospective studies 證據品質 五項前瞻性研究
Grade of recommendation Grade 0-Statement: unclear, additional research needed 推薦等級 0 級-聲明:尚不明確,需要進一步研究
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Available evidence suggests that weight loss interventions may improve both the treatment and long-term outcome of chronic non-communicable diseases. In periodontitis patients, these interventions may consist of specific educational messages tailored to the patients’ age and general 現有證據顯示,減重介入措施可能改善慢性非傳染性疾病的治療與長期預後。對於牙周炎患者,這些措施可能包含根據患者年齡與整體狀況量身訂製的特定衛教訊息
health. These should be supported with positive behavioural change towards healthier diets and increase in physical activity (exercise). 健康。這些措施應輔以積極的行為改變,朝向更健康的飲食和增加體能活動(運動)。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), five prospective studies, in obese gingivitis/periodontitis patients, on the impact of weight loss interventions were identified, with different follow-ups (18 months, 12 months, 24 weeks and two studies of 12 weeks). Periodontal interventions were not clearly defined. Intensity of lifestyle modifications aiming at weight loss interventions ranged from a briefing, followed by counselling in dietary change, to an 8-week high-fibre, low-fat diet, or a weight reduction programme with diet and exercise-related lifestyle modifications. Three studies reported beneficial periodontal outcomes and, the other two, no differences. 在系統性文獻回顧(Ramseier 等人,2020 年)中,針對肥胖牙齦炎/牙周炎患者,共識別出五項關於減重介入影響的前瞻性研究,追蹤時間各不相同(18 個月、12 個月、24 週以及兩項 12 週研究)。牙周介入措施未明確定義。旨在減重的生活方式調整強度範圍廣泛,從簡報說明後進行飲食改變諮詢,到為期 8 週的高纖維低脂飲食,或結合飲食與運動相關生活調整的減重計畫。其中三項研究報告顯示對牙周狀況有益,另兩項則未見差異。
Additional factors have been discussed in the overall evaluation of risk factor control. 在風險因子控制的整體評估中,已討論了其他相關因素。
6 | CLINICAL RECOMMENDATIONS: SECOND STEP OF THERAPY 6 | 臨床治療建議:第二階段治療
The second step of therapy (also known as cause-related therapy) is aimed at the elimination (reduction) of the subgingival biofilm and calculus and may be associated with removal of root surface (cementum). The procedures aimed at these objectives have received in the scientific literature different names: subgingival debridement, subgingival scaling, root planning, etc. (Kieser, 1994). In this guideline, we have agreed to use the term “subgingival instrumentation” to all non-surgical procedures, either performed with hand (i.e. curettes) or power-driven (i.e. sonic/ultrasonic devices) instruments specifically designed to gain access to the root surfaces in the subgingival environment and to remove subgingival biofilm and calculus. This second step of therapy requires the successful implementation of the measures described in the first step of therapy. 第二階段治療(又稱病因相關治療)旨在消除(或減少)牙齦下菌斑和牙結石,並可能涉及牙根表面(牙骨質)的移除。科學文獻中對這些治療程序有不同稱呼:牙齦下清創術、牙齦下刮治術、根面平整術等(Kieser, 1994)。本指南統一採用「牙齦下器械處理」一詞,泛指所有非手術性治療程序,無論是使用手動器械(如刮治器)或動力器械(如聲波/超音波設備),這些器械專門設計用於進入牙齦下環境接觸牙根表面,並清除牙齦下菌斑和牙結石。此階段治療需在第一階段治療措施成功實施後進行。
Furthermore, subgingival instrumentation may be supplemented with the following adjunctive interventions: 此外,牙齦下器械處理可輔以下列附加介入措施:
Use of adjunctive physical or chemical agents. 使用物理或化學輔助劑。
Use of adjunctive host-modulating agents (local or systemic). 使用輔助性宿主調節劑(局部或全身性)。
Use of adjunctive subgingival locally delivered antimicrobials. 使用輔助性牙齦下局部投予抗菌劑。
Use of adjunctive systemic antimicrobials. 使用輔助性全身性抗菌劑。
R2.1 | Is subgingival instrumentation beneficial for the treatment of periodontitis? R2.1 | 牙周下刮治對於牙周炎的治療是否有益?
Evidence-based recommendation (2.1) 實證建議 (2.1)
We recommend that subgingival instrumentation be employed to treat periodontitis in order to reduce probing pocket depths, gingival inflammation and the number of diseased sites. 我們建議採用牙周下刮治來治療牙周炎,以減少探測牙周囊袋深度、牙齦發炎及病變部位的數量。
Supporting literature Suvan et al. (2019) 參考文獻 Suvan 等人 (2019)
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 建議等級 A 級- uarr uarr\uparrow \uparrow
Strength of consensus Unanimous consensus (2.6% of the group abstained due to potential Col) 共識強度 全體一致共識(2.6%小組成員因潛在利益衝突棄權)
Evidence-based recommendation (2.1)
Quality of evidence One 3-month RCT ( n=169 patients); 11 prospective studies (n=258) >= 6 months
Grade of recommendation Grade A- uarr uarr
Strength of consensus Unanimous consensus (2.6% of the group abstained due to potential Col)| Evidence-based recommendation (2.1) |
| :--- |
| Quality of evidence One 3-month RCT ( $n=169$ patients); 11 prospective studies $(n=258) \geq 6$ months |
| Grade of recommendation Grade A- $\uparrow \uparrow$ |
| Strength of consensus Unanimous consensus (2.6% of the group abstained due to potential Col) |
Background 背景
Intervention 介入措施
Subgingival instrumentation aims at reducing soft tissue inflammation by removing hard and soft deposits from the tooth surface. The endpoint of treatment is pocket closure, defined by probing pocket depth (PPD) <= 4mm\leq 4 \mathrm{~mm} and absence of bleeding on probing (BOP). 牙齦下器械治療旨在透過清除牙齒表面的硬質和軟質沉積物,來減輕軟組織的發炎情況。治療的終點目標是達到牙周囊袋閉合,其定義為探測囊袋深度(PPD) <= 4mm\leq 4 \mathrm{~mm} 且探測時無出血(BOP)。
Available evidence 現有證據
One RCT on 169 patients with 3-month outcomes addressed the PICOS question. Further 11 prospective studies ( n=258n=258 ) with a follow-up of >= 6\geq 6 months which considered baseline measures and post-treatment reductions in probing pocket depth (primary outcome) and bleeding on probing and percentage of closed pockets (secondary outcomes) were analysed. 一項針對 169 名患者進行 3 個月追蹤的隨機對照試驗探討了 PICOS 問題。另外分析了 11 項前瞻性研究( n=258n=258 ),追蹤期為 >= 6\geq 6 個月,這些研究考量了基準測量值以及治療後探測牙周囊袋深度(主要結果)的減少,以及探測出血和閉合囊袋百分比(次要結果)。
Risk of bias 偏差風險
Study quality assessment identified a low risk of bias in all but one study, which had a high risk of bias. 研究品質評估顯示,除一項具有高偏差風險的研究外,其餘研究皆為低偏差風險。
Consistency 一致性
Evidence was consistent across all 11 studies that were included in the pre- and post-treatment analysis and was therefore considered strong. Patient-reported outcomes were inconsistently reported and adverse events, when reported, were rare. No indications of publication bias were observed but heterogeneity was high. 在所有 11 項納入治療前後分析的研究中,證據呈現一致性,因此被認為具有強度。患者自述結果的報告不一致,而當有報告不良事件時,其發生率相當低。未觀察到出版偏誤的跡象,但異質性偏高。
Clinical relevance and effect size 臨床相關性與效應量
The evidence suggested a mean reduction of PPD of 1.7 mm at 6//86 / 8 months, a mean proportion of closed pockets of 74%74 \% and a mean reduction of BOP of 63%. Deeper sites ( > 6mm>6 \mathrm{~mm} ) demonstrated a greater mean PPD reduction of 2.6 mm . 證據顯示平均牙周囊袋探測深度(PPD)在 6//86 / 8 個月時減少 1.7 毫米,平均閉合囊袋比例達 74%74 \% ,且平均出血指數(BOP)降低 63%。較深部位( > 6mm>6 \mathrm{~mm} )顯示更大的平均 PPD 減少量,達 2.6 毫米。
Balance of benefits and harm 效益與風險的平衡
An overall consideration of the benefit versus harm of subgingival instrumentation supports the strength of the recommendation. 全面考量牙齦下器械治療的利弊後,支持此建議的強度。
Ethical considerations 倫理考量
Evaluation of the efficacy of subgingival debridement is ethically challenging as it would entail comparison with no subgingival intervention. Due to the lack of relevant RCTs, prospective studies were included and their data analysed. 評估牙齦下清創術的療效在倫理上具有挑戰性,因為這需要與未進行牙齦下介入的情況進行比較。由於缺乏相關隨機對照試驗,因此納入前瞻性研究並分析其數據。
Applicability 適用性
The majority of studies were conducted in well-controlled research environments and included specifically selected populations, that is those with no systemic disease. While results from studies involving populations with systemic diseases were not included in the systematic review, there is a consensus that subgingival instrumentation is efficacious in these groups (Sanz et al., 2018, 2019), but the magnitude of the effect requires further study. 大多數研究都是在控制良好的研究環境中進行,並納入了特定篩選的族群,即那些沒有全身性疾病的患者。雖然系統性回顧並未包含涉及全身性疾病族群的研究結果,但專家共識認為,牙齦下器械治療對這些族群同樣有效(Sanz 等人,2018、2019 年),但其效果程度仍需進一步研究。
The evidence presented illustrates “efficacy” rather than “effectiveness”; therefore, generalizability to general dental practice settings is unclear. 現有證據顯示的是「療效」而非「實際效果」;因此,能否推廣至一般牙科臨床實務尚不明確。
R2.2 | Are treatment outcomes of subgingival instrumentation better after use of hand, powered (sonic/ ultrasonic) instruments or a combination thereof? R2.2 | 使用手動器械、動力(聲波/超聲波)器械或兩者結合後,牙齦下器械治療的療效是否更佳?
Evidence-based recommendation (2.2) 實證建議(2.2)
We recommend that subgingival periodontal instrumentation is performed with hand or powered (sonic/ultrasonic) instruments, either alone or in combination. 我們建議使用手動或動力(聲波/超音波)器械進行牙周下刮治,可單獨使用或合併使用。
Supporting literature Suvan et al. (2019) 支持文獻 Suvan 等人(2019)
Quality of evidence Four RCTs (n=132)(n=132) with a follow-up of >= 6\geq 6 months. 證據品質 四項隨機對照試驗 (n=132)(n=132) ,追蹤期為 >= 6\geq 6 個月。
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 推薦等級 A 級 uarr uarr\uparrow \uparrow
Strength of consensus Unanimous consensus (6.2% of the group abstained due to potential Col) 共識強度 全體一致共識(6.2%的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Numerous types of instruments are available to perform subgingival instrumentation. 有多種器械可用於執行牙齦下刮治。
Available evidence 現有證據
Four RCTs ( n=132n=132 ) with a low overall risk of bias were included. Findings were evaluated at 6//86 / 8 months for PPD reduction (primary outcome) and clinical attachment level (CAL) gain (secondary outcome). 共納入四項隨機對照試驗( n=132n=132 ),整體偏誤風險較低。研究結果於 6//86 / 8 個月時評估牙周囊袋深度(PPD)減少(主要結果指標)及臨床附連水平(CAL)增益(次要結果指標)。
Risk of bias 偏誤風險
Study quality assessment identified all four studies to be at low risk of bias. 研究品質評估確認所有四項研究皆屬低偏誤風險。
Consistency 一致性
The evidence demonstrated that outcomes of treatment were not dependent on the type of instrument employed. The evidence was considered strong and consistent. No indications of publication bias were observed but heterogeneity was high. 證據顯示治療結果與所使用的器械類型無關。此證據被認為具有強力且一致性。未觀察到出版偏誤的跡象,但異質性很高。
Clinical relevance 臨床相關性
No clinically or statistically significant differences were observed between the different types of instruments. 不同類型器械之間未觀察到具有臨床或統計學顯著差異。
Balance of benefits and harm 效益與風險的平衡
The use of all types of instruments is technique-sensitive and therefore requires specific training. Patient-reported outcomes and adverse events were inconsistently reported. If present, no obvious differences between hand and powered instruments in terms of post-operative sensitivity were noted. 所有類型器械的使用都對操作技術敏感,因此需要進行專門培訓。患者報告的結果和不良事件報告不一致。如果有報告,手動器械和動力器械在術後敏感度方面沒有明顯差異。
Ethical considerations 倫理考量
There is a potential ethical dilemma in that patient preference may conflict with the clinician’s preference in terms of type of instrument. Patient autonomy should be respected. 存在潛在的倫理困境,因為患者偏好可能在器械類型方面與臨床醫師偏好產生衝突。應尊重患者的自主權。
Economic considerations 經濟考量
Cost-effectiveness has not been evaluated in these studies. Furthermore, there is no evidence that the use of one type of instrument is superior in terms of requisite treatment time. 這些研究並未評估成本效益。此外,沒有證據顯示使用某一種類型的器械在所需治療時間方面具有優勢。
Applicability 適用性
The majority of studies were conducted in well-controlled research environments, in specifically selected populations and under local anaesthetic. Clinicians should be aware that new instrument choices (i.e. mini instruments) were not evaluated in the available studies. The choice of instrument should be based upon the experience/skills and preference of the operator together with patient preference. 大多數研究是在嚴格控制的研究環境中進行的,對象為特定篩選人群且採用局部麻醉。臨床醫師應注意,現有研究並未評估新型器械選擇(如迷你器械)。器械選擇應基於操作者的經驗/技術與偏好,同時考量患者偏好。
R2.3 | Are treatment outcomes of subgingival R2.3 | 牙齦下治療的結果是否
instrumentation better when delivered quadrant-wise over multiple visits or as a full mouth procedure (within 24 hr)) ? 在多次就診時分象限進行治療,或是在 24 小時內完成全口治療,哪種方式能提供更好的器械操作效果?
Evidence-based recommendation (2.3) 實證基礎建議(2.3)
We suggest that subgingival periodontal instrumentation can be performed with either traditional quadrant-wise or full mouth delivery within 24 hr . 我們建議,牙周器械的牙齦下治療可以採用傳統的分象限方式,或在 24 小時內完成全口治療。
Supporting literature Suvan et al. (2019) 參考文獻 Suvan 等人(2019)
Quality of evidence Eight RCTs (n=212)(n=212) with a follow-up of >= 6\geq 6 months. 證據品質 八項隨機對照試驗 (n=212)(n=212) ,追蹤期為 >= 6\geq 6 個月。
Grade of recommendation Grade B- uarr\uparrow 建議等級 B-級 uarr\uparrow
Strength of consensus Strong consensus (3.8% of the group abstained due to potential Col) 共識強度 強烈共識(3.8%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入治療
Subgingival instrumentation has traditionally been delivered during multiple sessions (e.g. quadrant-wise). As an alternative, full-mouth protocols have been suggested. Full-mouth protocols included single stage and two-stage therapy within 24 hr ; however, protocols including antiseptics (full-mouth disinfection) were not included in this analysis. 傳統上,牙齦下器械治療會分多次進行(例如按象限處理)。作為替代方案,也有人提出全口治療方案。全口治療方案包括在 24 小時內完成的單階段和兩階段治療;然而,本分析並未納入包含抗菌劑(全口消毒)的治療方案。
Available evidence 現有證據
Eight RCTs (n=212)(n=212) with a follow-up of >= 6\geq 6 months were included demonstrating a low risk of bias. Outcome measures reported were PPD reduction (primary outcome), CAL gain, BOP reduction and pocket closure (secondary outcomes). 共納入 8 項隨機對照試驗 (n=212)(n=212) ,追蹤期為 >= 6\geq 6 個月,顯示偏見風險較低。報告的結果指標包括牙周袋探測深度(PPD)減少(主要結果)、臨床附著水平(CAL)增加、出血指數(BOP)降低及牙周袋閉合(次要結果)。
Risk of bias 偏誤風險
Study quality assessment identified all eight studies at low risk of bias. 研究品質評估顯示所有八項研究皆屬低偏誤風險。
Consistency 一致性
The evidence suggested that outcomes of treatment were not dependent on the type of delivery (protocol) employed. The evidence was considered strong and consistent. No indications of publication bias were observed, and heterogeneity was low. The results confirm the findings of a recent Cochrane systematic review (Eberhard, Jepsen, Jervoe-Storm, Needleman, & Worthington, 2015). 證據顯示治療結果與採用的實施方式(方案)無關。該證據被認為具有強度且一致。未觀察到出版偏誤跡象,異質性亦低。此結果驗證了近期 Cochrane 系統性文獻回顧(Eberhard, Jepsen, Jervoe-Storm, Needleman & Worthington, 2015)的研究發現。
Clinical relevance 臨床相關性
No substantial differences were observed between the two treatment modalities. 兩種治療方式之間未觀察到顯著差異。
Balance of benefits and harm 效益與風險的平衡
Clinicians should be aware that there is evidence of systemic implications (e.g. acute systemic inflammatory response) with full-mouth protocols. Thus, such an approach should always include careful consideration of the general health status of the patient. 臨床醫師應注意,全口治療方案有證據顯示可能引發全身性影響(例如急性全身性發炎反應)。因此,採用此類治療方式時,必須謹慎評估患者的整體健康狀況。
Ethical considerations 倫理考量
There is a potential ethical dilemma in that patient preference may conflict with the clinician’s recommendation in terms of mode of treatment delivery. Patient autonomy should be respected. 在治療方式的選擇上,患者偏好可能與臨床醫師的建議產生衝突,這存在潛在的倫理困境。應尊重患者的自主權。
Legal considerations 法律考量
Potential adverse systemic effects of full-mouth treatment protocols in certain risk patients should be considered. 對於特定風險病患,全口治療方案可能產生的全身性不良影響應納入考量。
Economic considerations 經濟效益評估
Limited evidence on the cost-effectiveness of different modes of delivery is available. 目前關於不同治療方式成本效益的證據仍有限。
Patient preferences 病患偏好
Patient-reported outcomes were inconsistently reported, and there is no evidence supporting one approach over the other. Reports of increased discomfort and side effects, evident in studies on fullmouth disinfection, were not included in the present analysis. 患者報告的結果並不一致,且沒有證據支持某一種方法優於另一種。關於全口消毒研究中明顯增加的不適感和副作用報告,並未納入本次分析。
Applicability 適用性
The majority of studies were conducted in well-controlled environments, included specifically selected populations and were undertaken in a number of different continents. 大多數研究是在控制良好的環境中進行,納入了特定選擇的人群,並在多個不同大洲展開。
6.2 | Intervention: Use of adjunctive physical agents to subgingival instrumentation 6.2 | 介入治療:使用輔助物理劑進行齦下器械治療
R2.4 | Are treatment outcomes with adjunctive application of laser superior to non-surgical subgingival instrumentation alone? R2.4 | 輔助性雷射治療的療效是否優於單純非手術性牙齦下器械治療?
Evidence-based recommendation (2.4) 實證基礎建議 (2.4)
We suggest not to use lasers as adjuncts to subgingival instrumentation. 我們建議不要使用雷射作為牙齦下器械的輔助治療。
Supporting literature Salvi et al. (2019) 支持文獻 Salvi 等人 (2019)
Quality of evidence Two RCTs ( n=46n=46, wavelengths 2,780nm2,780 \mathrm{~nm} and 2,940nm2,940 \mathrm{~nm} ) and 3 RCTs ( n=101n=101, wavelength range 810-980nm810-980 \mathrm{~nm} ) with single laser application reporting 6-month outcomes. Two RCTs reported mean PPD changes. 證據品質 兩項隨機對照試驗( n=46n=46 ,波長 2,780nm2,780 \mathrm{~nm} 和 2,940nm2,940 \mathrm{~nm} )和三項隨機對照試驗( n=101n=101 ,波長範圍 810-980nm810-980 \mathrm{~nm} )報告了單次雷射應用的 6 個月結果。兩項隨機對照試驗報告了平均牙周袋探測深度變化。
Grade of recommendation Grade B- darr\downarrow 推薦等級 B 級 darr\downarrow
Strength of consensus Simple majority (3.8% of the group abstained due to potential Col) 共識強度 簡單多數(3.8%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入治療
Lasers offer the potential to improve outcomes of subgingival root surface treatment protocols when used as adjuncts to traditional root surface instrumentation. Depending upon the wavelength and settings employed, some lasers can ablate subgingival calculus and exert antimicrobial effects. The evidence reported to inform the current guidelines has grouped lasers into two main wavelength categories: lasers with a wavelength range of 2,7802,940nm2,940 \mathrm{~nm} and lasers with a wavelength range of 810-980 nm. 雷射作為傳統根面器械治療的輔助工具,具有改善牙齦下根面治療效果的潛力。根據使用的波長與參數設定,某些雷射能清除牙齦下牙結石並發揮抗菌作用。本次指南所依據的證據將雷射分為兩大波長類別:波長範圍 2,780 2,940nm2,940 \mathrm{~nm} 的雷射,以及波長範圍 810-980 奈米的雷射。
Available evidence 現有證據
Evidence was available from five RCTs (total n=147n=147 ) with a followup of >= 6\geq 6 months and a single laser application. Only RCTs reporting mean PPD changes were considered and this recommendation is made in the light of this approach to the systematic review. 證據來自五項隨機對照試驗(總計 n=147n=147 ),追蹤期為 >= 6\geq 6 個月且僅進行單次雷射治療。僅考量報告平均牙周囊袋深度變化的隨機對照試驗,此建議是基於此系統性文獻回顧方法所提出。
Risk of bias 偏差風險
The majority of studies displayed unclear risk of bias. 多數研究顯示出不明確的偏差風險。
Consistency 一致性
Studies differed in terms of laser type, tip diameter, wavelength, mode of periodontal treatment, number of treated sites, population and several possible combinations of these parameters. 各項研究在雷射類型、探頭直徑、波長、牙周治療方式、治療部位數量、受試族群以及這些參數的多種可能組合方面存在差異。
Clinical relevance and effect size 臨床相關性與效應量
There is insufficient evidence to recommend adjunctive application of lasers to subgingival instrumentation. 目前證據不足以支持在牙齦下器械治療中輔助使用雷射。
Balance of benefits and harm 效益與風險的平衡
The majority of the studies did not report on potential harm/adverse effects. 多數研究並未報告潛在風險/不良反應
Economic considerations 經濟考量
Additional costs associated with adjunctive laser therapy may not be justified. 輔助性雷射治療的額外成本可能不具合理性
Patient preferences 病患偏好
Patient-reported outcomes were rarely reported. 病患自述結果鮮少被報告
Applicability 適用性
The majority of studies were conducted in university settings, included specifically selected populations and were undertaken in a number of different countries. 多數研究於大學環境中進行,納入特定篩選族群,並在數個不同國家執行
R2.5 | Are treatment outcomes with adjunctive antimicrobial photodynamic therapy (aPDT) superior to non-surgical subgingival instrumentation alone? R2.5 | 輔助性抗菌光動力療法(aPDT)的治療效果是否優於單純的非手術性齦下器械治療?
Evidence-based recommendation (2.5) 實證建議(2.5)
We suggest not to use adjunctive a PDT at wavelength ranges of either 660-670nm660-670 \mathrm{~nm} or 800-900nm800-900 \mathrm{~nm} in patients with periodontitis. 我們建議不要對牙周炎患者使用波長範圍為 660-670nm660-670 \mathrm{~nm} 或 800-900nm800-900 \mathrm{~nm} 的輔助性 aPDT 治療。
Supporting literature Salvi et al. (2019) 參考文獻 Salvi 等人(2019)
Quality of evidence Five RCTs ( n=121n=121, wavelength range 660670 nm and wavelength range 800-900nm800-900 \mathrm{~nm} ) with single aPDT application reporting 6-month outcomes. Three RCTs reported mean PPD changes. 證據品質 五項隨機對照試驗( n=121n=121 ,波長範圍 660-670 奈米及波長範圍 800-900nm800-900 \mathrm{~nm} )採用單次抗菌光動力療法,報告六個月追蹤結果。其中三項試驗報告了平均牙周囊袋探測深度變化。
Grade of recommendation Grade B- darr\downarrow 建議等級 B 級 darr\downarrow
Strength of consensus Consensus (1.3% of the group abstained due to potential Col) 共識強度 共識(1.3%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入治療
Adjunctive antimicrobial photodynamic therapy (aPDT) is an approach used to improve the antimicrobial effects of traditional root surface decontamination methods. It functions by attaching a photosensitizing dye to the normally impermeable outer cell membrane of Gramnegative bacteria and then uses laser light to generate reactive oxygen species through the membrane-bound dye to locally destroy those bacteria. 輔助性抗菌光動力療法(aPDT)是一種用於增強傳統根面去汙方法抗菌效果的技術。其作用機制是將光敏染料附著於革蘭氏陰性菌通常不可滲透的外細胞膜上,再利用雷射光透過膜結合染料產生活性氧物種,從而局部消滅這些細菌。
Available evidence 現有證據
Evidence was available from five RCTs ( n=121n=121 ) with a follow-up of >= 6\geq 6 months and a single aPDT application. Only RCTs reporting mean PPD changes were included in the meta-analysis, and this recommendation is made in the light of this approach to the systematic review. 證據來自五項隨機對照試驗( n=121n=121 ),追蹤期為 >= 6\geq 6 個月且僅單次施用 aPDT。本統合分析僅納入報告平均牙周囊袋探測深度(PPD)變化的隨機對照試驗,此項建議係基於系統性文獻回顧之方法學所提出。
Risk of bias 偏誤風險
The majority of studies displayed unclear risk of bias. 多數研究顯示出不明確的偏誤風險。
Consistency 一致性
Substantial heterogeneity across the studies was identified, in terms of laser type, photosensitizer, wavelength, mode of periodontal 研究間存在顯著異質性,包括雷射類型、光敏劑、波長及牙周治療模式等方面。
treatment, number of treated sites, population and several possible combinations of these parameters. 治療、治療部位數量、族群以及這些參數的多種可能組合。
Clinical relevance and effect size 臨床相關性與效應量
No benefits were observed with the adjunctive application of aPDT. 使用輔助性 aPDT 治療並未觀察到任何益處。
Balance of benefits and harm 效益與傷害的平衡
The majority of the studies reported on adverse events with no harm associated with the adjunctive application of aPDT. 多數研究報告指出,輔助應用 aPDT 並未造成相關不良事件。
Economic considerations 經濟考量
Additional costs associated with adjunctive laser therapy may not be justified. 輔助雷射治療所增加的額外成本可能不具合理性。
Patient preferences 病患偏好
Patient-reported outcomes were rarely reported, and there is no evidence supporting one approach over the other. 患者報告的結果鮮少被記錄,且沒有證據支持某一種方法優於其他方法。
Applicability 適用性
All studies were conducted in well controlled university settings or specialist centres, included specifically selected populations and were undertaken in a number of different countries. 所有研究皆在嚴格控制的大學環境或專科醫師中心進行,納入特定篩選的族群,並在多個不同國家實施。
6.3 | Intervention: Use of adjunctive hostmodulating agents (local or systemic) to subgingival instrumentation 6.3 | 介入措施:使用輔助性宿主調節劑(局部或全身性)配合牙齦下器械治療
R2.6 | Does the adjunctive use of local statins improve the clinical outcome of subgingival instrumentation? R2.6 | 局部使用他汀類藥物作為輔助治療是否能改善牙周下刮治的臨床效果?
Evidence-based recommendation (2.6) 實證建議 (2.6)
We recommend not to use local administration of statin gels (atorvastatin, simvastatin, rosuvastatin) as adjuncts to subgingival instrumentation. 我們建議不要使用局部施用的他汀類凝膠(阿托伐他汀、辛伐他汀、羅蘇伐他汀)作為牙周下刮治的輔助治療。
Supporting literature Donos et al. (2019) 支持文獻 Donos 等人 (2019)
Quality of evidence Twelve placebo-controlled RCTs ( n=753n=753 ), for 1.2%1.2 \% atorvastatin (six RCTs, n=180n=180 ), 1.2%1.2 \% simvastatin gel ( 5 RCTs, n=118n=118 ) and 1.2%1.2 \% rosuvastatin gel (four RCTs, n=122n=122 ) 證據品質 十二項安慰劑對照隨機對照試驗( n=753n=753 ),針對 1.2%1.2 \% 阿托伐他汀(六項隨機對照試驗, n=180n=180 )、 1.2%1.2 \% 辛伐他汀凝膠(五項隨機對照試驗, n=118n=118 )以及 1.2%1.2 \% 羅蘇伐他汀凝膠(四項隨機對照試驗, n=122n=122 )
Grade of recommendation Grade A- darr darr\downarrow \downarrow 建議等級 A 級- darr darr\downarrow \downarrow
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Statins are known to have pleiotropic pharmacological effects in addition to their hypolipidemic properties. These include antioxidant and anti-inflammatory effects, the stimulation of angiogenesis, improvements in endothelial function and the positive regulation of bone formation pathways (Adam & Laufs, 2008; Mennickent, Bravo, Calvo, & Avello, 2008; Petit et al., 2019). 除了降血脂特性外,已知他汀類藥物還具有多效性藥理作用。這些作用包括抗氧化和消炎藥效果、促進血管新生、改善內皮功能以及正向調節骨骼形成途徑(Adam & Laufs, 2008; Mennickent, Bravo, Calvo, & Avello, 2008; Petit et al., 2019)。
Recent evidence suggests that statins may also attenuate periodontal inflammation, as reflected by decreases in pro-inflammatory and increases in anti-inflammatory mediators within the gingival crevicular fluid (GCF) of patients with periodontitis (Cicek Ari et al., 2016). 最新證據顯示,他汀類藥物可能還能減輕牙周發炎,這反映在牙周炎患者的齦溝液(GCF)中促炎介質減少而消炎藥介質增加(Cicek Ari et al., 2016)。
Available evidence 現有證據
Twelve placebo-controlled RCTs ( n=753n=753 ), all derived from the same research group, assessed the effect of local statin gels in adjunctive non-surgical therapy for infrabony or furcation Class II defects. PPD reduction (primary outcome) was reported at 6 and 9 months for 1.2%1.2 \% atorvastatin ( 6 RCTs, n=180n=180 ), 1.2% simvastatin gel (five RCTs, n=118n=118 ) and 1.2%1.2 \% rosuvastatin gel (four RCTs, n=122n=122 ). Meta-analysis was performed in nine RCTs ( n=607n=607 ). 十二項安慰劑對照的隨機對照試驗( n=753n=753 ),皆來自同一研究團隊,評估了局部施打 statin 凝膠作為輔助非手術治療對骨下缺損或二級分叉病變的效果。研究報告了在 6 個月和 9 個月時,使用 1.2%1.2 \% atorvastatin(6 項 RCT, n=180n=180 )、1.2% simvastatin 凝膠(5 項 RCT, n=118n=118 )以及 1.2%1.2 \% rosuvastatin 凝膠(4 項 RCT, n=122n=122 )對於牙周探測深度(主要結果指標)的改善效果。其中九項 RCT( n=607n=607 )進行了統合分析。
Risk of bias 偏誤風險
There was a moderate overall risk of bias in the studies analysed. Three of 12 studies presented with a high risk of bias in at least one domain. One study was moderately underpowered. While pharmaceutical companies provided the statins in the included studies, the level of involvement of industry in the analysis and interpretation of the results is unclear. 分析顯示這些研究存在中度整體偏誤風險。十二項研究中有三項在至少一個評估領域呈現高偏誤風險。其中一項研究統計檢定力明顯不足。雖然納入研究的 statin 藥物由製藥公司提供,但產業界對結果分析與解讀的參與程度尚不明確。
Consistency 一致性
Meta-analysis of nine RCTs where statins had been applied to a single site per patient demonstrated that adjunctive local application of 1.2% statin gels in infrabony defects led to a mean difference in PPD reduction of 1.83 mm (95% confidence interval (CI) [1.31; 2.36]) at 6 months and of 2.25 mm ( 95%Cl95 \% \mathrm{Cl} [1.88; 2.61]) at 9 months. Only one study investigated locally delivered statins in Class II furcation defects. 針對九項隨機對照試驗(每位患者單一部位施用 statin)的統合分析顯示,在骨下缺損處輔助性局部施用 1.2% statin 凝膠,6 個月時可達到 1.83 毫米(95%信賴區間[1.31; 2.36])的牙周囊袋深度(PPD)減少平均差異,9 個月時則達 2.25 毫米( 95%Cl95 \% \mathrm{Cl} [1.88; 2.61])。僅有一項研究探討局部投予 statin 於第二類分叉缺損的療效。
Clinical relevance 臨床相關性
Although the mean estimates suggested a clinically meaningful benefit from adding statin gels to subgingival instrumentation, there was a large prediction interval for PPD reduction at 6 months (-0.08mm(-0.08 \mathrm{~mm} to 3.74 mm ) and the I^(2)I^{2} (95.1%) indicating wide heterogeneity of data and therefore caution needs to be adopted when assessing the efficacy of statins. While the prediction interval at 9 months (1.163.34 mm ) improved over 6-month results, heterogeneity ( I^(2)I^{2} statistic) of 65.4%65.4 \% still indicated moderate inconsistency in results. Since the outcomes of the different statin gels were considered as one group during the meta-analysis, it is not possible to draw definitive conclusions on which statin offered higher efficacy. 雖然平均估值顯示輔助使用 statin 凝膠於齦下器械治療具有臨床顯著效益,但 6 個月時 PPD 減少的預測區間範圍較大( (-0.08mm(-0.08 \mathrm{~mm} 至 3.74 毫米)且 I^(2)I^{2} (95.1%)顯示數據存在高度異質性,因此在評估 statin 療效時需謹慎解讀。儘管 9 個月時的預測區間(1.16 至 3.34 毫米)較 6 個月結果改善,但 I^(2)I^{2} 統計量顯示的@3%仍表明結果存在中度不一致性。由於統合分析中將不同 statin 凝膠的療效視為同一組別,故無法確切判定何種 statin 具有更高療效。
Balance of benefits and harms 效益與風險平衡
All studies included in the review reported that patients tolerated local statins well, without any complications, adverse reactions/side effects or allergic symptoms. 所有納入回顧的研究皆報告患者對局部他汀類藥物耐受性良好,未出現任何併發症、不良反應/副作用或過敏症狀。
Economic considerations 經濟考量
There is an additional cost associated with the use of statins that is borne by the patient. 使用他汀類藥物會產生由患者承擔的額外費用。
Ethical and legal considerations 倫理與法律考量
The statin formulations included in the systematic review are “offlabel” and an approved formulation with appropriate good manufacturing practice quality control (Good Manufacturing Practice, GMP) and patient’s safety validation is not available. 系統性回顧中所包含的斯達汀製劑屬於「仿單標示外使用」,且目前尚無具備優良製造規範(GMP)品質管控與患者安全性驗證的核准製劑。
Applicability 適用性
The same research group published all data within the RCTs, thereby restricting the generalizability of the results, which need to be confirmed in future larger (multicentre) RCTs by independent groups, with multilevel analyses to account for potential confounding factors (e.g. medical history, smoking history). In addition, future studies will need to clarify which type of statin is more effective. 所有隨機對照試驗數據皆由同一研究團隊發表,因此限制了研究結果的普遍適用性,未來需要由獨立團隊進行更大規模(多中心)的隨機對照試驗,並採用多層次分析來排除潛在干擾因素(如病史、吸菸史)以驗證結果。此外,後續研究仍需釐清何種類型的斯達汀具有更佳療效。
R2.7 | Does the adjunctive use of probiotics improve the clinical outcome of subgingival instrumentation? R2.7 | 輔助使用益生菌是否能改善牙周袋器械治療的臨床效果?
Evidence-based recommendation (2.7) 實證基礎建議(2.7)
We suggest not to use probiotics as an adjunct to subgingival instrumentation 我們建議不要使用益生菌作為牙齦下器械治療的輔助手段
Supporting literature Donos et al. (2019) 支持文獻 Donos 等人(2019)
Quality of evidence Five placebo controlled RCTs ( n=176n=176 ) testing preparations containing L. ramnosus SP1, L. reuteri or the combination of S. oralis KJ3, S. uberis KJ2 and S. rattus JH145. 證據品質 五項安慰劑對照隨機臨床試驗( n=176n=176 )測試含有 L. ramnosus SP1、L. reuteri 或 S. oralis KJ3、S. uberis KJ2 與 S. rattus JH145 組合的製劑
Grade of recommendation Grade B- darr\downarrow 建議等級 B 級 - darr\downarrow
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 全體共識 (0%成員因潛在利益衝突棄權)
Background 背景
Intervention 治療措施
Probiotics are defined as “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host” (FAO/WHO). It has been suggested that probiotics may alter the ecology of micro-environmental niches such as periodontal pockets, and as such, they may disrupt an established dysbiosis. This may re-establish a symbiotic flora and a beneficial interaction with the host via several mechanisms including modulation of the immuneinflammatory response, regulation of antibacterial substances and exclusion of potential pathogens via nutritional and spatial competition (Gatej, Gully, Gibson, & Bartold, 2017). This guideline does not include evidence on the use of probiotics in supportive periodontal therapy. 益生菌被定義為「當攝取足夠數量時,能對宿主健康帶來益處的活微生物」(聯合國糧農組織/世界衛生組織)。研究指出,益生菌可能改變牙周囊袋等微環境生態,從而打破已形成的菌群失調狀態。這可能透過多種機制重建共生菌群與宿主的良性互動,包括調節免疫發炎反應、調控抗菌物質,以及透過營養與空間競爭排除潛在病原體(Gatej, Gully, Gibson, & Bartold, 2017)。本指南未納入關於益生菌用於牙周支持治療的證據。
Available evidence 現有證據
Five placebo-controlled RCTs ( n=176n=176 ) assessed the adjunctive effect of probiotics to subgingival instrumentation. Two studies from the same group used a preparation containing L. ramnosus SP1 ( 2xx10^(7)2 \times 10^{7} colony forming units). Two other RCTs from another research group used a preparation containing L. reuteri. One study evaluated a combination of S. oralis KJ3, S. uberis KJ2 and S. rattus 五項安慰劑對照隨機臨床試驗( n=176n=176 )評估了益生菌作為牙齦下器械治療輔助效果。其中兩項來自同一團隊的研究使用含 L. ramnosus SP1( 2xx10^(7)2 \times 10^{7} 菌落形成單位)的製劑,另兩項來自其他團隊的試驗則使用含 L. reuteri 的製劑。一項研究評估了 S. oralis KJ3、S. uberis KJ2 與 S. rattus 的組合效果。
JH145. Meta-analysis was performed on PPD reduction (primary outcome) at 6 months. JH145. 針對 6 個月時牙周袋深度(PPD)縮減(主要結果)進行了統合分析。
Risk of bias 偏誤風險
All studies had an overall low risk of bias. Two out of the five studies declared industrial sponsorship, and three received the probiotics from industry. 所有研究整體偏誤風險皆低。五項研究中有兩項聲明獲得產業贊助,三項研究使用的益生菌由業界提供。
Consistency 一致性
Meta-analysis of five RCTs demonstrated that, compared with placebo, treatment with probiotics resulted in a mean difference in PPD reduction of 0.38mm(95%Cl[-0.14;0.90])0.38 \mathrm{~mm}(95 \% \mathrm{Cl}[-0.14 ; 0.90]) at 6 months. The confidence interval and I^(2)I^{2} statistic (93.3%) suggested considerable heterogeneity for the effect of the treatment with the different formulations. 針對五項隨機對照試驗的統合分析顯示,與安慰劑相比,益生菌治療在 6 個月時可平均降低牙周探測深度 0.38mm(95%Cl[-0.14;0.90])0.38 \mathrm{~mm}(95 \% \mathrm{Cl}[-0.14 ; 0.90]) 。其信賴區間與 I^(2)I^{2} 統計量(93.3%)表明,不同配方治療效果存在顯著異質性。
Clinical relevance 臨床相關性
The mean estimated difference in PPD reduction between probiotics and placebo was not statistically significant and of limited clinical relevance (difference < 0.5mm<0.5 \mathrm{~mm} ). Moreover, two groups published four out of the five RCTs included each of them using a different probiotic formulation. Preparations containing Lactobacillus reuteri were the only ones to demonstrate improved PPD reductions. 益生菌與安慰劑在牙周探測深度降低方面的平均估計差異未達統計顯著性,且臨床相關性有限(差異 < 0.5mm<0.5 \mathrm{~mm} )。此外,其中四項隨機對照試驗由兩個研究團隊發表,各自使用不同益生菌配方。僅含羅伊氏乳桿菌的製劑顯示出較佳的牙周探測深度改善效果。
Given that probiotics embrace a broad range of micro-organisms and types of preparations, combining such data within the same me-ta-analysis poses an interpretational challenge. 考量到益生菌涵蓋廣泛的微生物種類與製劑型態,將這些數據整合至同一項統合分析中會造成詮釋上的挑戰。
Balance of benefits and harms 效益與風險的平衡
All formulations appeared to be safe and patients did not report adverse effects. 所有配方似乎都安全無虞,患者並未回報不良反應。
Economic considerations 經濟效益考量
There is an additional cost associated with the use of probiotics that is borne by the patient. 使用益生菌需由患者自行負擔額外費用。
Applicability 適用性
All studies were conducted in two countries, and no conclusions can be drawn on the effectiveness of probiotics as adjuncts to subgingival instrumentation. 所有研究僅在兩個國家進行,因此無法就益生菌作為牙齦下器械輔助治療的有效性得出結論。
R2.8 | Does the adjunctive use of systemic sub-antimicrobial dose doxycycline (SDD) to subgingival instrumentation improve clinical outcomes? R2.8 | 全身性次抗菌劑量多西環素(SDD)輔助牙齦下器械治療是否能改善臨床結果?
Evidence-based recommendation (2.8) 實證建議(2.8)
We suggest not to use systemic sub-antimicrobial dose doxycycline (SDD) as an adjunct to subgingival instrumentation. 我們建議不要將全身性次抗菌劑量多西環素(SDD)作為牙齦下器械治療的輔助療法。
Supporting literature Donos et al. (2019) 支持文獻 Donos 等人(2019 年)
Quality of evidence Eight placebo-controlled RCTs (14 publications, n=610n=610 ). Meta-analysis on PPD reduction was performed in five RCTs ( n=484n=484 ) 證據品質 八項安慰劑對照隨機對照試驗(14 篇出版物, n=610n=610 )。其中五項隨機對照試驗進行了牙周袋探測深度減少的統合分析( n=484n=484 )
Evidence-based recommendation (2.8) 實證基礎建議 (2.8)
Grade of recommendation Grade B- darr\downarrow 建議等級 B 級 - darr\downarrow
Strength of consensus Consensus (1.3% of the group abstained due to potential Col) 共識強度 共識 (1.3%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
Sub-antimicrobial dose doxycycline (up to 40 mg a day) is a systemic drug employed specifically for its anti-inflammatory as opposed to its antimicrobial properties. The formulation offers anti-collagenolytic activity, which may have utility in reducing connective tissue breakdown and augmenting healing responses following subgingival instrumentation in periodontitis patients. 次抗菌劑量多西環素(每日最多 40 毫克)是一種全身性藥物,專門用於其消炎而非抗菌的特性。該配方具有抗膠原分解活性,可能有助於減少牙周炎患者在接受牙齦下器械治療後的結締組織分解並增強癒合反應。
Available evidence 現有證據
Eight placebo-controlled RCTs (14 publications, n=610n=610 ) reported on the systemic use of a sub-antimicrobial dose doxycycline (SDD) (up to 40 mg a day) in combination with subgingival instrumentation. Meta-analysis on PPD reduction (primary outcome) at 6 months post-subgingival instrumentation was performed in five RCTs (n=484)(n=484). 八項安慰劑對照的隨機對照試驗(14 篇出版物, n=610n=610 )報告了次抗菌劑量多西環素(SDD)(每日最多 40 毫克)與牙齦下器械治療聯合使用的系統性應用。其中五項隨機對照試驗 (n=484)(n=484) 在牙齦下器械治療後 6 個月進行了關於牙周袋深度減少(主要結果)的統合分析。
Risk of bias 偏差風險
One study was considered to be at high risk of bias and the remaining studies presented some concerns in certain domains. Of the five studies included in meta-analysis, three declared industrial sponsorship, one was sponsored by the academic institution, and the fifth did not declare funding. 一項研究被認為具有高偏誤風險,其餘研究在某些領域存在一些疑慮。在納入統合分析的五項研究中,三項聲明獲得產業贊助,一項由學術機構資助,第五項則未聲明資金來源。
Consistency 一致性
The systematic review included data from eight RCTs, but metaanalysis was performed in five RCTs that stratified pockets into moderate ( 4-6mm4-6 \mathrm{~mm} ) versus deep ( >= 7mm\geq 7 \mathrm{~mm} ). The findings were consistent in all studies. The I^(2)I^{2} statistic was 0%0 \% (95% Cl [0%; 64.1%]) for both moderate and deep pockets. Two out of five RCTs included did not report a power calculation. The strict experimental protocols employed by the five studies included in the meta-analysis limits the generalizability of the outcomes. 這項系統性回顧包含八項隨機對照試驗的數據,但僅對其中五項將牙周囊袋分為中度( 4-6mm4-6 \mathrm{~mm} )與深度( >= 7mm\geq 7 \mathrm{~mm} )的試驗進行統合分析。所有研究結果均呈現一致性。無論中度或深度囊袋,其 I^(2)I^{2} 統計量均為 0%0 \% (95%信賴區間[0%;64.1%])。五項納入試驗中有兩項未報告統計檢定力計算。參與統合分析的五項研究所採用的嚴格實驗方案,限制了研究結果的普遍適用性。
Clinical relevance of outcomes and effect size 結果的臨床相關性與效應量
Additional PPD reductions reported following the use of SDD were 0.22 mm at 6 months and 0.3 mm at 9 months in moderate depth pockets. The mean prediction interval ranged from 0.06 mm to 0.38 mm at 6 months and from 0.15 mm to 0.45 mm at 9 months. At deep sites, the additional PPD reductions were more clinically relevant, with 0.68 mm mean additional PPD reductions at 6 months and 0.62 mm at 9 months. The mean prediction interval ranged from 0.34 mm to 1.02 mm at 6 months and from 0.28 mm to 0.96 mm at 9 months. Percentage of pocket closure was not reported. 使用 SDD 後報告的額外牙周囊袋深度(PPD)減少量,在中等深度囊袋中 6 個月時為 0.22 毫米,9 個月時為 0.3 毫米。6 個月時平均預測區間為 0.06 毫米至 0.38 毫米,9 個月時為 0.15 毫米至 0.45 毫米。在深層部位,額外 PPD 減少量更具臨床意義,6 個月時平均額外減少 0.68 毫米,9 個月時減少 0.62 毫米。6 個月時平均預測區間為 0.34 毫米至 1.02 毫米,9 個月時為 0.28 毫米至 0.96 毫米。未報告囊袋閉合百分比。
Balance of benefits and harm 效益與風險平衡
Most studies in the SDD category did not report any serious adverse events or patient dropouts that were directly attributed to the medication. However, it is known that doxycycline may lead to elevations in liver enzymes, which was evident for some patients in the results of one RCT included in the systematic review (Caton et al., 2000, 2001). The sustainability of the benefits or adverse events beyond the study period is unknown. SDD 類別中的多數研究未報告任何直接歸因於藥物的嚴重不良事件或患者退出情況。然而已知多西環素可能導致肝酶升高,這在系統評價中納入的一項隨機對照試驗結果中對部分患者表現明顯(Caton 等人,2000 年,2001 年)。研究期後效益或不良事件的持續性尚不明確。
Ethical considerations 倫理考量
Current health policies on antibiotic stewardship and related public health concerns surrounding increasing antibiotic resistance need to be taken into account. The systemic effects of a drug taken over a 6- to 9-month period during the initial phase of subgingival instrumentation require careful consideration when extrapolating outcomes from controlled research trials into general clinical practice. 現行關於抗生素管理的健康政策,以及因抗生素抗藥性增加所引發的公共衛生疑慮,皆需納入考量。在將控制性研究試驗結果推論至一般臨床應用時,必須審慎評估於牙周器械治療初期階段持續服用 6 至 9 個月藥物所產生的全身性影響。
Legal considerations 法律考量
SDD is not approved or available in some European countries. 部分歐洲國家尚未核准或提供 SDD 療法。
Economic considerations 經濟考量
There is a cost associated with the use of SDD that is borne by the patient. 使用 SDD(局部藥物遞送系統)會產生由患者負擔的相關費用。
Applicability 適用性
SSD is mainly effective in deep sites ( >= 7mm\geq 7 \mathrm{~mm} ), although SDD is used as a systemic rather than a site-specific treatment. The clinical significance in deep sites ( 0.68 mm at 6 months and 0.62 mm at 9 months) is small, given that re-treatment with non-surgical root debridement might yield additional PPD reductions, and local drug delivery systems may yield similar effect sizes. Moreover, the five studies that did stratify results based upon pocket depth did not present an a priori statistical plan powered to stratify results in that manner. 雖然 SDD 是作為全身性而非局部特定治療使用,但 SSD(全身性抗生素)主要對深牙周袋有效( >= 7mm\geq 7 \mathrm{~mm} )。考慮到非手術性根面平整再治療可能帶來額外的牙周探測深度(PPD)減少,且局部藥物遞送系統可能產生相似效果,深牙周袋的臨床意義(6 個月時 0.68 毫米,9 個月時 0.62 毫米)其實不大。此外,五項根據牙周袋深度分層呈現結果的研究,並未事先制定具有統計效力的分層分析計劃。
R2.9 | Does the adjunctive use of systemic/local bisphosphonates to subgingival instrumentation improve clinical outcomes? R2.9 | 在牙齦下器械治療中輔助使用全身/局部雙磷酸鹽類藥物,是否能改善臨床結果?
Evidence-based recommendation (2.9) 實證建議(2.9)
We recommend not to use locally delivered bisphosphonate (BP) gels or systemic BPs as an adjunct to subgingival instrumentation. 我們建議不要使用局部投予的雙磷酸鹽(BP)凝膠或全身性雙磷酸鹽作為牙周器械治療的輔助療法。
Supporting literature Donos et al. (2019) 支持文獻 Donos 等人(2019)
Quality of evidence Seven placebo-controlled RCTs ( n=348n=348 ), on local delivery of 1% alendronate gel (six studies) and 0.5% zolendronate gel (one study); two placebo-controlled RCTs ( n=90n=90 ) on systemic administration of BPs (alendronic acid and risedronate). 證據品質 七項安慰劑對照隨機臨床試驗( n=348n=348 ),針對 1% alendronate 凝膠局部投予(六項研究)和 0.5% zolendronate 凝膠局部投予(一項研究);兩項安慰劑對照隨機臨床試驗( n=90n=90 )針對雙磷酸鹽全身性投予(alendronic acid 和 risedronate)。
Grade of recommendation Grade A- darr darr\downarrow \downarrow 建議等級 A 級 - darr darr\downarrow \downarrow
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Bisphosphonates (BPs) are a class of antiresorptive agents that act mainly by inhibiting osteoclast activity. BPs can also directly inhibit host degradative enzymes like matrix metalloproteinases released by osteoclasts and other cells of the periodontium. There is also evidence that BPs reduce osteoblast apoptosis, thus increasing bone density as an overall therapeutic outcome. It is therefore rational to speculate that BPs may benefit the management of inflammationmediated alveolar bone resorption in periodontitis patients (Badran, Kraehenmann, Guicheux, & Soueidan, 2009). 雙磷酸鹽類藥物(BPs)是一類抗骨吸收劑,主要通過抑制破骨細胞活性發揮作用。BPs 還能直接抑制宿主降解酶,如破骨細胞和牙周組織其他細胞釋放的基質金屬蛋白酶。另有證據表明 BPs 可減少成骨細胞凋亡,從而提高骨骼密度作為整體治療效果。因此推測 BPs 可能有助於治療牙周炎患者因炎症介導的齒槽骨吸收是合理的(Badran, Kraehenmann, Guicheux, & Soueidan, 2009)。
Available evidence 現有證據
Seven placebo-controlled RCTs ( n=348n=348 ), all from the same research group, on local delivery of 1% alendronate gel (six studies) and 0.5% zolendronate gel (one study) in infrabony or furcation Class II defects were identified. 七項安慰劑對照的隨機對照試驗( n=348n=348 )均來自同一研究團隊,這些研究針對齒槽骨缺損或二級分叉病變局部施用 1%阿侖膦酸凝膠(六項研究)和 0.5%唑來膦酸凝膠(一項研究)進行評估。
A meta-analysis on PPD reduction at 6 months in five RCTs ( n=228n=228 ) using either single or multiple sites per patient in infrabony defects was undertaken. Two placebo-controlled RCTs ( n=90n=90 ) evaluated systemic administration of BPs (alendronate and risedronate). 針對五項隨機對照試驗( n=228n=228 )進行統合分析,評估齒槽骨缺損患者單一或多處病灶在 6 個月後牙周囊袋探測深度(PPD)的減少情況。另有兩項安慰劑對照試驗( n=90n=90 )評估全身性投予雙磷酸鹽類藥物(阿侖膦酸和利塞膦酸)的效果。
Risk of bias 偏誤風險
Of the nine studies included, two were at high risk of bias and seven presented some concerns in at least one of the domains of the risk of bias assessment tool. One study was underpowered. All studies on local BPs were published by the same research group. While pharmaceutical companies provided bisphosphonates for local application in the included studies, the level of involvement of industry in the analysis and interpretation of the results is unclear. 在納入的九項研究中,兩項存在高偏誤風險,七項在偏誤評估工具的至少一個領域中存有疑慮。其中一項研究樣本數不足。所有關於局部雙磷酸鹽的研究皆由同一研究團隊發表。雖然製藥公司在納入研究中提供局部應用的雙磷酸鹽藥物,但產業界對結果分析與解讀的參與程度尚不明確。
Consistency 一致性
Nine RCTs were available, two involving systemic administration of BPs. No meta-analysis was therefore undertaken for systemic BPs. Out of the seven RCTs involving local application of BPs, five were on infrabony defects (four employed 1% Alendronate gel and one study used 0.5%0.5 \% Zolendronate gel), while two were undertaken on furcation Class II defects (all using 1% Alendronate gel). A meta-analysis of five studies using single or multiple sites per patient demonstrated a significant benefit in terms of PPD reduction of 2.15 mm ( 95%Cl95 \% \mathrm{Cl} [1.75; 2.54]) after 6 months from non-surgical periodontal therapy in infrabony defects, with a low level of heterogeneity ( I^(2)=47.3%I^{2}=47.3 \% ). 共有九項隨機對照試驗可供參考,其中兩項涉及雙磷酸鹽類藥物的全身性給藥。因此未對全身性雙磷酸鹽進行統合分析。在七項涉及局部應用雙磷酸鹽的隨機對照試驗中,五項針對骨下缺損(四項使用 1%阿侖膦酸凝膠,一項研究使用 0.5%0.5 \% 唑來膦酸凝膠),另兩項則針對第二類分叉缺損(均使用 1%阿侖膦酸凝膠)。對五項採用每位患者單一或多處部位的研究進行統合分析顯示,在非手術性牙周治療後六個月,骨下缺損的探測深度(PPD)顯著減少 2.15 毫米( 95%Cl95 \% \mathrm{Cl} [1.75;2.54]),且異質性程度較低( I^(2)=47.3%I^{2}=47.3 \% )。
Clinical relevance 臨床相關性
The results of the two studies on systemic BPs were poorly comparable as they were undertaken in different populations and involved different confounding factors (e.g. smoking). 關於全身性雙磷酸鹽的兩項研究結果可比性較差,因其在不同族群中進行且涉及不同干擾因素(如吸菸)。
Although the mean estimates suggested adjunctive benefits from adjunctive use of BP gels, the combined use of studies considering single and multiple sites per patient in the meta-analysis should be taken into consideration. 雖然平均估計值顯示使用 BP 凝膠作為輔助治療具有附加效益,但在進行統合分析時,應將同時納入每位患者單一部位與多部位的研究設計納入考量。
Balance of benefits and harm 效益與風險的平衡
Both systemic and local BPs were well-tolerated in the studies reported in the systematic review and were not associated with severe adverse reactions. 根據系統性文獻回顧所報告的研究結果,無論是全身性或局部性 BP 藥物都具有良好的耐受性,且未出現嚴重不良反應。
Economic considerations 經濟效益考量
There is an additional cost associated with the use of bisphosphonates that is borne by the patient. 使用雙磷酸鹽類藥物會產生額外費用,需由患者自行負擔。
Ethical and legal considerations 倫理與法律考量
The balance of recognized potential severe risks (e.g. osteochemonecrosis of the jaws) versus benefits resulted in a consensus that systemic administration of BPs should not be recommended in the clinical management of periodontal bone loss. It is important to note that BP gel formulations are “off-label” and an approved formulation with appropriate quality control (GMP) and patient safety validation is not available. 考量到公認的潛在嚴重風險(例如顎骨骨壞死)與效益之間的平衡,專家達成共識認為在牙周骨骼流失的臨床治療中,不應建議全身性投予雙磷酸鹽類藥物。需特別注意的是,雙磷酸鹽凝膠製劑屬於「仿單標示外使用」,目前尚無具備適當品質管制(GMP)及通過病患安全驗證的核准配方。
Applicability 適用性
The same research group/centre published all data on locally delivered BPs; therefore, the generalizability of the results requires substantiating in future larger (multicentre) RCTs, with multilevel analyses accounting for potential confounding factors (e.g. medical history, smoking history). 由於所有關於局部投予雙磷酸鹽的研究數據皆由同一研究團隊/中心發表,因此研究結果的普遍適用性仍需透過未來更大規模(多中心)的隨機對照試驗加以驗證,並採用多層次分析來考量潛在干擾因素(例如用藥史、吸菸史)。
R2.10 | Does adjunctive use of systemic/local non-steroidal anti-inflammatory drugs to subgingival instrumentation improve the clinical outcomes? R2.10 | 輔助使用全身性或局部性非類固醇消炎藥於牙齦下器械治療,是否能改善臨床結果?
Evidence-based recommendation (2.10) 實證建議 (2.10)
We recommend not to use systemic or local non-steroidal anti-inflammatory drugs (NSAIDs) as an adjunct to subgingival instrumentation 我們建議不要使用全身性或局部性非類固醇消炎藥(NSAIDs)作為牙齦下器械治療的輔助療法
Supporting literature Donos et al. (2019) 參考文獻 Donos 等人(2019)
Quality of evidence Two placebo-controlled RCTs (n=88)(n=88) on local application (1% flurbiprofen toothpaste; irrigation with 200 ml buffered 0.3%0.3 \% acetylsalicylic acid); two placebo-controlled RCTs ( n=133n=133 ) on systemic applications (celecoxib, diclofenac potassium) 證據品質 兩項安慰劑對照的隨機對照試驗(使用 1%氟比洛芬牙膏局部塗抹;以 200 毫升緩衝乙醯水楊酸溶液沖洗);另兩項安慰劑對照隨機對照試驗(系統性給藥:塞來昔布、雙氯芬酸鉀)
Grade of recommendation Grade A- darr darr\downarrow \downarrow 建議等級 A 級(0#)
Strength of consensus Strong consensus (1.3% of the group abstained due to potential Col) 共識強度 強烈共識(1.3%小組成員因潛在利益衝突棄權)
Background 背景說明
Intervention 介入措施
Periodontitis is an inflammatory disease in which altered immuneinflammatory responses to a dysbiotic biofilm drives connective tissue destruction and bone loss. It is reasonable therefore that nonsteroid anti-inflammatory drugs (NSAIDs), may be effective as adjunctive periodontal therapies. 牙周炎是一種發炎性疾病,其特徵是對菌群失調的生物膜產生異常的免疫發炎反應,導致結締組織破壞與骨骼流失。因此,非類固醇消炎藥(NSAIDs)作為輔助性牙周治療可能具有療效。
Available evidence 現有證據
Two placebo-controlled RCTs (n=88)(n=88) on local application, one using 1% flurbiprofen toothpaste twice daily for 12 months and a second using subgingival daily irrigation with 200 ml buffered 0.3%0.3 \% acetylsalicylic acid, were identified. Two placebo-controlled RCTs ( n=133n=133 ) on systemic applications, one RCT using systemic celecoxib ( 200 mg daily 6 months) and another using a cyclical regime of diclofenac potassium ( 50 mg 2 -months, then 2 months off, then 2 months on), were included. All studies reported on PPD reduction at 6 months. No meta-analysis was performed due to the limited number of studies identified and their heterogeneity. 研究發現兩項關於局部用藥的安慰劑對照隨機臨床試驗( (n=88)(n=88) ),其中一項使用 1%氟比洛芬牙膏每日兩次持續 12 個月,另一項則每日以 200 毫升緩衝 0.3%0.3 \% 乙醯水楊酸進行牙齦下沖洗。另納入兩項關於全身性用藥的安慰劑對照隨機臨床試驗( n=133n=133 ),一項試驗使用全身性塞來昔布(每日 200 毫克持續 6 個月),另一項採用雙氯芬酸鉀的循環用藥方案(50 毫克用藥 2 個月後停藥 2 個月,再恢復用藥 2 個月)。所有研究均報告了 6 個月後的牙周探測深度(PPD)減少情況。由於納入研究數量有限且存在異質性,未進行統合分析。
Risk of bias 偏誤風險
Two out of four studies were considered at high risk of bias. All studies on NSAIDs either did not provide information on sample size calculation or were underpowered. All studies declared industry funding. 四項研究中有兩項被認為具有高偏誤風險。所有關於非類固醇抗炎藥的研究,要麼未提供樣本量計算的資訊,要麼統計檢定力不足。所有研究皆聲明獲得產業資助。
Consistency 一致性
It was not possible to undertake a meta-analysis of local or systemic NSAID administration as an adjunct to subgingival instrumentation because the studies were heterogeneous (not comparable) in terms of the medication employed and the modality of administration. 由於所採用的藥物和給藥方式存在異質性(無法比較),因此無法對局部或全身性非類固醇抗發炎藥(NSAID)作為牙齦下器械治療輔助進行統合分析。
Clinical relevance 臨床相關性
Local NSAIDs did not enhance the clinical outcomes of subgingival instrumentation. Systemic NSAIDs exhibited limited clinical benefits, but their heterogeneity did not permit the drawing of clinically meaningful conclusions. 局部 NSAID 並未增強牙齦下器械治療的臨床效果。全身性 NSAID 雖展現有限的臨床效益,但其異質性使得無法得出具有臨床意義的結論。
Balance of benefits and harm 效益與風險的平衡
No serious adverse events were reported. 未報告嚴重不良事件。
Ethical considerations 倫理考量
Long-term use of systemic NSAIDs carries a well-known risk of unwanted side effects, which raises concerns over their use as adjuncts to subgingival instrumentation. 長期使用全身性非類固醇抗發炎藥物(NSAIDs)具有已知的副作用風險,這引發了對其作為牙齦下器械治療輔助用藥的疑慮。
Economic considerations 經濟考量
There would be a cost to using NSAIDs which would ultimately transfer to the patient. 使用非類固醇消炎藥(NSAIDs)會產生成本,最終將轉嫁給患者。
Applicability 適用性
We do not encourage everyday clinical use of systemic NSAIDs or to conduct future studies to test these medications in their current standard formulations or dosage regimes. No meaningful conclusions could be made regarding use of local NSAIDs. Based on the current limited evidence, local NSAIDs did not provide a clinical benefit. 我們不鼓勵在日常臨床中使用全身性 NSAIDs,也不建議以現行標準配方或劑量方案進行未來研究來測試這些藥物。關於局部使用 NSAIDs 無法得出有意義的結論。根據目前有限的證據,局部 NSAIDs 並未提供臨床效益。
R2.11 | Does the adjunctive use of omega-3 polyunsaturated fatty acids (PUFA) improve the clinical outcome of subgingival instrumentation? R2.11 | 輔助使用 omega-3 多元不飽和脂肪酸(PUFA)是否能改善牙周刮治的臨床效果?
Evidence-based recommendation (2.11) 實證建議(2.11)
We recommend not to use omega-3 PUFAs as an adjunct to subgingival instrumentation. 我們不建議將 omega-3 多元不飽和脂肪酸作為牙周下器械治療的輔助療法。
Supporting literature Donos et al. (2019) 支持文獻 Donos 等人(2019)
Quality of evidence Three placebo-controlled RCTs ( n=160n=160 ) with 6-month administration of omega-3 PUFAs. 證據品質 三項安慰劑對照隨機臨床試驗( n=160n=160 )使用 omega-3 多元不飽和脂肪酸進行 6 個月治療。
Grade of recommendation Grade A- darr darr\downarrow \downarrow 推薦等級 A 級( darr darr\downarrow \downarrow )
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 共識(0%的組員因潛在利益衝突而棄權)
Evidence-based recommendation (2.11)
We recommend not to use omega-3 PUFAs as an adjunct to subgingival instrumentation.
Supporting literature Donos et al. (2019)
Quality of evidence Three placebo-controlled RCTs ( n=160 ) with 6-month administration of omega-3 PUFAs.
Grade of recommendation Grade A- darr darr
Strength of consensus Consensus (0% of the group abstained due to potential Col)| Evidence-based recommendation (2.11) |
| :--- |
| We recommend not to use omega-3 PUFAs as an adjunct to subgingival instrumentation. |
| Supporting literature Donos et al. (2019) |
| Quality of evidence Three placebo-controlled RCTs ( $n=160$ ) with 6-month administration of omega-3 PUFAs. |
| Grade of recommendation Grade A- $\downarrow \downarrow$ |
| Strength of consensus Consensus (0% of the group abstained due to potential Col) |
Background 背景
Intervention 介入措施
The recent discovery of pro-resolving lipid mediators by Serhan and colleagues [reviewed by (Serhan, 2017)], some of which are produced by the metabolism of two major omega-3 polyunsaturated fatty acids (PUFAs), namely eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA) to E- and D-resolvins, respectively, raises the potential for essential dietary PUFAs as adjunctive hostmodulating therapeutics for non-surgical periodontal treatment. However, few studies have investigated their efficacy in human trials. Serhan 及其團隊近期發現的前分解脂質介質[由(Serhan, 2017)回顧],其中部分是由兩種主要 omega-3 多元不飽和脂肪酸(PUFAs)——即二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)分別代謝為 E 型與 D 型分解素所產生,這項發現提升了必需膳食 PUFAs 作為非手術性牙周治療輔助宿主調節療法的潛力。然而,目前鮮少有人體試驗研究其療效。
Available evidence 現有證據
Three placebo-controlled RCTs (n=160)(n=160) with 6-month administration of omega-3 PUFAs. Heterogeneity in study designs precluded a meta-analysis. One RCT investigated low dose omega-3 PUFAs ( 6.25 mg eicosapentaenoic acid -EPA and 19.9 mg docosahexaenoic acid -DHA) twice daily for 6 months; a second study employed high dose omega-3 PUFAs ( 3 g ) in combination with 81 mg aspirin daily for 6 months; and a third study used 1 g omega-3 PUFAs twice daily for 6 months. All studies provided PPD reduction data at 6 months post-subgingival instrumentation. No meta-analysis was performed due to the limited number of studies identified and their heterogeneity. 三項安慰劑對照的隨機臨床試驗(RCTs) (n=160)(n=160) 進行了為期 6 個月的 omega-3 多元不飽和脂肪酸(PUFAs)給藥。研究設計的異質性使得無法進行統合分析。其中一項 RCT 調查了低劑量 omega-3 PUFAs(每日兩次,每次含 6.25 毫克二十碳五烯酸-EPA 和 19.9 毫克二十二碳六烯酸-DHA),持續 6 個月;第二項研究採用高劑量 omega-3 PUFAs(每日 3 克)並搭配 81 毫克阿斯匹靈,持續 6 個月;第三項研究則使用每日兩次、每次 1 克 omega-3 PUFAs,持續 6 個月。所有研究均提供了牙齦下器械治療後 6 個月的牙周袋探測深度(PPD)減少數據。由於所識別的研究數量有限且存在異質性,因此未進行統合分析。
Risk of bias 偏誤風險
One out of three studies was considered to be at high risk of bias. One study reported industry support, one was supported by a University, and one did not disclose the funding source. 三項研究中有一項被認為具有高偏誤風險。一項研究報告獲得產業支持,一項由大學資助,另一項則未公開資金來源。
Consistency 一致性
No meta-analysis could be performed due to the low number of available studies and study heterogeneity in terms of proposed regime and formulation. 由於現有研究數量不足,且在治療方案和製劑配方方面存在異質性,因此無法進行統合分析。
Clinical relevance 臨床相關性
Since the three RCTs used different doses and preparations of omega-3 PUFAs and one out of three studies combined omega-3 with 81 mg aspirin, it was not possible to draw clinically meaningful conclusions from the data. 由於這三項隨機對照試驗使用了不同劑量和配方的 Omega-3 多元不飽和脂肪酸,且其中一項研究還結合了 81 毫克的阿斯匹靈,因此無法從這些數據中得出具有臨床意義的結論。
Balance of benefits and harm 效益與風險的平衡
No adverse events were associated to the use of omega-3 PUFAs, and they are essentially a relatively safe dietary supplement. 使用 Omega-3 多元不飽和脂肪酸並未出現不良事件,基本上它是一種相對安全的膳食補充劑。
Economic considerations 經濟考量
There would be a cost to using omega-3 PUFAs which would ultimately transfer to the patient. 使用 Omega-3 多元不飽和脂肪酸將產生成本,最終會轉嫁給患者。
Applicability 適用性
There is insufficient data to support or refute the use of omega-3 PUFAs, either as a monotherapy or as a combined therapeutic adjunct to subgingival instrumentation. The combination of omega- 3 fatty acids and low-dose aspirin also warrants further assessment of its use as an adjunct in the management of periodontitis. 目前數據不足以支持或反駁 Omega-3 多元不飽和脂肪酸的使用,無論是作為單一療法或作為牙周器械治療的輔助聯合療法。Omega-3 脂肪酸與低劑量阿司匹林的組合療法,也需進一步評估其作為牙周炎治療輔助手段的效果。
R2.12 | Does the adjunctive use of local metformin improve the clinical outcome of subgingival instrumentation? R2.12 | 局部使用二甲雙胍作為輔助治療是否能改善牙周器械治療的臨床效果?
Evidence-based recommendation (2.12) 實證基礎建議(2.12)
We recommend not to use local administration of metformin gel as adjunct to subgingival instrumentation. 我們建議不要使用局部施用的二甲雙胍凝膠作為牙齦下器械治療的輔助療法。
Supporting literature Donos et al. (2019) 支持文獻 Donos 等人(2019)
Quality of evidence Six placebo-controlled RCTs ( n=313n=313 ) on locally delivered 1% metformin gel 證據品質 六項關於局部施用 1%二甲雙胍凝膠的安慰劑對照隨機臨床試驗( n=313n=313 )
Grade of recommendation Grade A— darr darr\downarrow \downarrow 建議等級 A 級— darr darr\downarrow \downarrow
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入治療
Metformin is a second-generation biguanide used to manage type 2 diabetes mellitus. There is evidence suggesting that metformin decreases inflammation and oxidative stress and may also have an osteogenic effect by increasing the proliferation of osteoblasts and reducing osteoclast activity (Araujo et al., 2017). It is therefore plausible that this medication may be beneficial in treating a chronic inflammatory disease like periodontitis. 二甲雙胍是一種第二代雙胍類藥物,用於治療第二型糖尿病。有證據表明,二甲雙胍能降低發炎反應和氧化壓力,並可能通過增加成骨細胞增殖和減少破骨細胞活性而具有促成骨作用(Araujo 等人,2017 年)。因此,這種藥物可能有益於治療像牙周炎這樣的慢性發炎性疾病。
Available evidence 現有證據
Six placebo-controlled RCTs ( n=313n=313 ) from the same research group investigated locally delivered 1% metformin gel as an adjunct to subgingival instrumentation. All studies reported on PPD reduction at 6 months post-subgingival instrumentation, and a meta-analysis was undertaken combining the six RCTs. 來自同一研究團隊的六項安慰劑對照隨機對照試驗( n=313n=313 )研究了局部施用 1%二甲雙胍凝膠作為牙齦下刮治輔助治療的效果。所有研究都報告了牙齦下刮治後 6 個月的牙周袋探測深度減少情況,並對這六項隨機對照試驗進行了統合分析。
Risk of bias 偏誤風險
Four out of six studies presented some concerns of risk of bias in most of the domains. All studies were published by the same research group. While pharmaceutical companies provided metformin, the level of involvement of industry in the analysis and interpretation of the results is unclear. 六項研究中有四項在大多數評估領域存在偏誤風險的疑慮。所有研究均由同一研究團隊發表。雖然製藥公司提供了二甲雙胍,但產業界在結果分析和解釋中的參與程度尚不明確。
Consistency 一致性
Meta-analysis of six studies (four considering single sites per patient and two considering multiple sites per patient) indicated that 1% metformin gel as adjunct to subgingival instrumentation led to an improved PPD reduction of 2.07mm(95%Cl[1.83;2.31])2.07 \mathrm{~mm}(95 \% \mathrm{Cl}[1.83 ; 2.31]) at 6 months. Heterogeneity between the studies was low (I^(2)=43%)\left(I^{2}=43 \%\right). 針對六項研究(四項考量每位患者的單一部位,兩項考量每位患者的多個部位)進行的統合分析顯示,1%二甲雙胍凝膠作為牙齦下器械治療的輔助,在 6 個月時能改善牙周袋深度(PPD)減少達 2.07mm(95%Cl[1.83;2.31])2.07 \mathrm{~mm}(95 \% \mathrm{Cl}[1.83 ; 2.31]) 。研究間的異質性較低 (I^(2)=43%)\left(I^{2}=43 \%\right) 。
Clinical relevance 臨床相關性
All studies reported a benefit in terms of PPD reduction when 1% metformin gel was used as an adjunct to subgingival instrumentation. However, studies using single and multiple sites per patients were combined. 所有研究均報告,當使用 1%二甲雙胍凝膠作為牙齦下器械治療的輔助時,在牙周袋深度(PPD)減少方面具有益處。然而,這些研究結合了每位患者單一部位與多個部位的數據。
Balance of benefits and harms 效益與風險的平衡
All studies included in the review reported that patients tolerated local metformin gel well, without any complications, adverse reac-tions/side-effects, or symptoms of hypersensitivity. 所有納入回顧的研究均報告患者對局部使用的二甲雙胍凝膠耐受性良好,未出現任何併發症、不良反應/副作用或過敏症狀。
Ethical and legal considerations 倫理與法律考量
The metformin formulation included in the systematic review is “offlabel” and an approved formulation with appropriate quality control (GMP) and patient safety validation is not available. 系統性回顧中所包含的二甲雙胍製劑屬於「仿單標示外使用」,目前尚無具備適當品質管控(GMP)與病患安全驗證的核准配方。
Economic considerations 經濟考量
There is an additional cost associated with the use of metformin that is borne by the patient. 使用二甲雙胍會產生由患者自行負擔的額外費用。
Applicability 適用性
The same research group published all data on local metformin; therefore, the generalizability of the results needs to be confirmed in future larger (multicentre) RCTs, with multi-level analyses accounting for potential confounding factors (e.g. medical history, smoking history). 同一個研究團隊發表了所有關於局部使用二甲雙胍的數據;因此,研究結果的普遍性需要在未來更大規模(多中心)的隨機對照試驗中進行驗證,並透過多層次分析來考量潛在的干擾因素(例如病史、吸煙史)。
6.4 | Intervention: Use of adjunctive chemical agents to subgingival instrumentation 6.4 | 介入措施:使用輔助化學藥物進行牙齦下器械治療
R2.13 | Does the adjunctive use of adjunctive chemotherapeutics (antiseptics) improve the clinical outcome of subgingival instrumentation? R2.13 | 輔助使用化學治療劑(抗菌劑)是否能改善牙齦下器械治療的臨床效果?
Adjunctive antiseptics may be considered, specifically chlorhexidine mouth rinses for a limited period of time, in periodontitis therapy, as adjuncts to mechanical debridement, in specific cases. 可考慮使用輔助性抗菌劑,特別是在特定情況下,於牙周炎治療中短期使用氯己定漱口水作為機械清創的輔助手段。
Supporting literature da Costa, Amaral, Barbirato, Leao, and Fogacci (2017) 支持文獻 da Costa、Amaral、Barbirato、Leao 和 Fogacci(2017)
Expert consensus-based recommendation (2.13) 專家共識基礎建議(2.13)
Grade of recommendation Grade 0-harr0-\leftrightarrow 建議等級 Grade 0-harr0-\leftrightarrow
Strength of consensus Consensus (6.3% of the group abstained due to potential Col) 共識強度 共識(6.3%的成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
In order to control gingival inflammation during periodontal therapy, the adjunctive use of some agents has been proposed. Chlorhexidine mouth rinses have been frequently tested in this indication and frequently used in different clinical settings. 為了控制牙周治療期間的牙齦發炎,有人建議輔助使用某些藥劑。在這個適應症中,氯己定漱口水經常被測試並廣泛應用於不同的臨床環境中。
Available evidence 現有證據
In the systematic reviews of the present European Workshop, the role of antiseptics in active periodontal therapy has not been directly addressed. However, some evidence is available based on studies on the role of chlorhexidine use after subgingival instrumentation (da Costa et al., 2017). 在本次歐洲研討會的系統性回顧中,並未直接探討抗菌劑在積極性牙周治療中的角色。然而,根據關於牙齦下器械處理後使用氯己定(chlorhexidine)的研究,已有部分證據可供參考(da Costa 等人,2017)。
In addition, other factors should be considered: 此外,還應考量其他因素:
It is unclear whether this should be a general recommendation for initial therapy. 目前尚不清楚這是否應作為初始治療的普遍建議。
It may be necessary to optimize mechanical plaque control before considering adjunctive chlorhexidine as an adjunct to subgingival instrumentation. 在考慮將氯己定作為牙齦下器械治療的輔助手段前,可能需要先優化機械性牙菌斑控制。
Specific considerations can be made when used in conjunction with full-mouth disinfection approaches and/or with systemic antimicrobials. 當與全口消毒療法及/或全身性抗生素合併使用時,可進行特殊考量。
The medical status of the patient. 患者的醫療狀況。
Adverse effects (staining) and economical costs should be considered. 應考量副作用(染色問題)與經濟成本。
6.5 | Intervention: Use of adjunctive locally administered antiseptics to subgingival instrumentation 6.5 | 介入措施:使用輔助性局部施用抗菌劑於牙齦下器械治療
R2.14 | Do adjunctive locally administered antiseptics improve the clinical outcome of subgingival instrumentation? R2.14 | 輔助性局部施用抗菌劑是否能改善牙齦下器械治療的臨床效果?
Locally administered sustained-release chlorhexidine as an adjunct to subgingival instrumentation in patients with periodontitis may be considered. 對於牙周炎患者,可考慮將局部施用的緩釋型氯己定作為牙齦下器械治療的輔助療法。
Supporting literature Herrera et al. (2020) 支持文獻 Herrera et al. (2020)
Quality of evidence Nine RCTs, 6-9 months. 718/719 patients. High risk of bias and heterogeneity among studies. 證據品質 九項隨機對照試驗,6-9 個月。718/719 名患者。研究存在高偏倚風險與異質性。
Grade of recommendation Grade 0-harr0-\leftrightarrow 推薦等級 Grade 0-harr0-\leftrightarrow
Strength of consensus Consensus (10.5% of the group abstained due to potential Col) 共識強度 共識(10.5%的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
There is insufficient evidence on the benefits of locally administered sustained-release antiseptics as an adjunct to subgingival debridement in patients with periodontitis. 目前證據不足以支持局部使用緩釋抗菌劑作為牙周炎患者牙齦下刮治輔助治療的效益。
Available evidence 現有證據
The systematic review (Herrera et al., 2020) revealed results from studies on products containing chlorhexidine (Periochip n=9n=9, Chlosite n=2n=2 ). One product (Periochip) demonstrated statistically significantly greater PPD reduction following single or multiple applications as an adjunct to subgingival debridement on short-term follow-up (6-9 months) (weighted mean difference (( WMD )=0.23)=0.23, 95%Cl95 \% \mathrm{Cl} [0.12; 0.34], p < .001p<.001 and significant heterogeneity). There are no long-term data available. No significant differences were found regarding CAL. Data on BOP were insufficient and no data on pocket closure or on number needed to treat (NNT) were provided. 系統性文獻回顧(Herrera 等人,2020 年)揭示了含氯己定產品(Periochip n=9n=9 、Chlosite n=2n=2 )的研究結果。其中一款產品(Periochip)在短期追蹤(6-9 個月)中作為齦下刮治輔助治療時,無論單次或多次應用均顯示出統計學上顯著更大的牙周囊袋深度(PPD)減少(加權平均差 (( WMD )=0.23)=0.23 , 95%Cl95 \% \mathrm{Cl} [0.12; 0.34], p < .001p<.001 且存在顯著異質性)。目前尚無長期數據可供參考。在臨床附著水平(CAL)方面未發現顯著差異。關於出血指數(BOP)的數據不足,且未提供囊袋閉合或需治療人數(NNT)的相關數據。
Risk of bias 偏誤風險
High risk of bias and heterogeneity among studies. 研究存在高偏倚風險與異質性問題。
Clinical relevance and effect size 臨床相關性與效應值
Effect size estimated for all PPD categories indicates an increased effect of about 10% in PPD reduction. 針對所有 PPD 分類估算的效應值顯示,PPD 減少效果約提升 10%。
Balance of benefit and harm 利益與風險的平衡
No increase in adverse effects or differences in patient-reported outcome measures (PROMs) were observed. 未觀察到不良反應增加或患者報告結果指標(PROMs)存在差異。
Economic considerations 經濟考量
The cost for the product and the limited availability of products in European countries need to be considered. 需考量產品成本及歐洲國家產品供應有限的問題。
6.6 | Intervention: Use of adjunctive locally administered antibiotics to subgingival instrumentation 6.6 | 介入措施:輔助性局部施用抗生素於牙周囊下器械治療
R2.15 | Do adjunctive locally administered antibiotics improve the clinical outcome of subgingival instrumentation? R2.15 | 輔助性局部施用抗生素是否能改善牙周下刮治的臨床效果?
Specific locally administered sustained-release antibiotics as an adjunct to subgingival instrumentation in patients with periodontitis may be considered. 對於牙周炎患者,可考慮在牙周下刮治時輔助使用特定局部緩釋型抗生素。
Supporting literature Herrera et al. (2020) 參考文獻 Herrera et al. (2020)
Quality of evidence PPD reduction (6-9 months): Atridox n=2n=2, 19/19 patients; Ligosan: n=3,232//236n=3,232 / 236 patients; Arestin: n=6n=6, 564//567564 / 567 patients. High risk of bias and heterogeneity in the majority of studies. 證據品質 PPD 減少(6-9 個月):Atridox n=2n=2 ,19/19 位患者;Ligosan: n=3,232//236n=3,232 / 236 位患者;Arestin: n=6n=6 , 564//567564 / 567 位患者。多數研究存在高偏見風險與異質性。
Grade of recommendation Grade 0- harr\leftrightarrow 建議等級 等級 0- harr\leftrightarrow
Strength of consensus Consensus (7.8% of the group abstained due to potential Col) 共識強度 共識(7.8%小組成員因潛在 Col 因素棄權)
Background 背景
Available evidence 現有證據
Of the products available on the European market, the systematic review (Herrera et al., 2020) revealed statistically significantly improved PPD reduction of locally applied antibiotics as an adjunct to subgingival debridement on short-term follow-up (6-9 months) for Atridox (two studies, WMD = 0.80; 95% CI [0.08; 1.52]; p = .028), Ligosan (three studies, WMD =0.52=0.52; 95% CI [0.28; 0.77]; pp < .001) and Arestin (six studies, WMD = 0.28; 95% CI [0.20; 0.36]; p < .001). No significant adjunctive long-term effect was evident. Statistically significantly improved CAL change for products used as an adjunct to subgingival debridement on short-term follow-up (6-9 months) was identified for Ligosan ( n=3n=3, WMD =0.41,95%=0.41,95 \% CI [0.06;0.75][0.06 ; 0.75]; p=.020p=.020 ) and Arestin ( n=4n=4, WMD =0.52=0.52; 95% CI [0.15; 0.88]; p=.019p=.019 ). Long-term data did not show significant improvement of CAL for any product. Data on BOP and pocket closure were insufficient. No information on NNT was provided. Estimated effect size indicates an increased effect of 10%-30% in PPD reduction. 在歐洲市場現有的產品中,系統性文獻回顧(Herrera 等人,2020 年)顯示,作為齦下刮治輔助治療的局部抗生素在短期追蹤(6-9 個月)期間,對於 Atridox(兩項研究,加權平均差=0.80;95%信賴區間[0.08;1.52];p=0.028)、Ligosan(三項研究,加權平均差 =0.52=0.52 ;95%信賴區間[0.28;0.77]; pp <0.001)和 Arestin(六項研究,加權平均差=0.28;95%信賴區間[0.20;0.36];p<0.001)具有統計學上顯著改善的牙周囊袋深度減少效果。未觀察到顯著的長期輔助效果。統計學上顯著改善的臨床附著水平變化在短期追蹤(6-9 個月)期間作為齦下刮治輔助治療的產品中,Ligosan( n=3n=3 ,加權平均差 =0.41,95%=0.41,95 \% 信賴區間 [0.06;0.75][0.06 ; 0.75] ; p=.020p=.020 )和 Arestin( n=4n=4 ,加權平均差 =0.52=0.52 ;95%信賴區間[0.15;0.88]; p=.019p=.019 )被確認。長期數據未顯示任何產品對臨床附著水平有顯著改善。關於出血指數和囊袋閉合的數據不足。未提供需治療人數相關資訊。估計效應值顯示牙周囊袋深度減少的改善效果增加 10%-30%。
Risk of bias 偏誤風險
High risk of bias and heterogeneity in the majority of studies. 大多數研究存在高風險的偏差和異質性。
Balance of benefit and harm 利益與風險的平衡
No increase in adverse effects or differences in PROMs were observed. Harm versus benefit considerations on the use of antibiotics need to be considered. 未觀察到不良反應增加或患者報告結果指標(PROMs)存在差異。需權衡使用抗生素的利弊考量。
Economic considerations 經濟考量
High economic costs and limited availability of products in European countries need to be considered. 需考量歐洲國家產品經濟成本高昂與供應有限的問題。
6.7 | Intervention: Use of adjunctive systemically administered antibiotics to subgingival instrumentation 6.7 | 介入措施:全身性抗生素輔助治療於齦下刮治的應用
R2.16 | Does adjunctive systemically administered antibiotics improve the clinical outcome of subgingival instrumentation? R2.16 | 全身性抗生素輔助治療是否能改善齦下刮治的臨床效果?
Evidence-based recommendation (2.16) 實證建議 (2.16)
A Due to concerns about patient’s health and the impact of systemic antibiotic use to public health, its routine use as adjunct to subgingival debridement in patients with periodontitis is not recommended. 考量患者健康狀況及全身性抗生素使用對公共衛生的影響,不建議將抗生素常規作為牙周炎患者進行牙齦下刮治的輔助治療。
B The adjunctive use of specific systemic antibiotics may be considered for specific patient categories (e.g. generalized periodontitis Stage III in young adults). 對於特定患者族群(例如年輕成人的廣泛性第三期牙周炎),可考慮使用特定全身性抗生素作為輔助治療。
Supporting literature Teughels et al. (2020) 參考文獻 Teughels 等人 (2020)
Quality of evidence RCTs ( n=28n=28 ) with a double-blind, placebocontrolled, parallel design. Risk of bias was low for 20 of the studies, while seven studies had a high risk. PPD reduction at 6 months; 證據品質:採用雙盲、安慰劑對照、平行設計的隨機對照試驗( n=28n=28 )。其中 20 項研究的偏誤風險較低,7 項研究則存在高風險。6 個月時的牙周袋探測深度(PPD)減少情況;
MET + AMOX: n=8,867n=8,867 patients. PPD reduction at 12 months; MET + AMOX: n=7,764n=7,764 patients, MET: n=2,259n=2,259 patients. 甲硝唑(MET)合併阿莫西林(AMOX)組: n=8,867n=8,867 名患者。12 個月時的 PPD 減少情況;MET+AMOX 組: n=7,764n=7,764 名患者,單獨 MET 組: n=2,259n=2,259 名患者。
Evidence-based recommendation (2.16) 實證建議(2.16)A Grade of recommendation Grade A- darr darr\downarrow \downarrow 建議等級 A 級 - darr darr\downarrow \downarrowB Grade of recommendation Grade 0-harr0-\leftrightarrow B 推薦等級 等級 0-harr0-\leftrightarrowA Strength of consensus Consensus ( 0%0 \% of the group abstained due to potential Col) A 共識強度 共識( 0%0 \% 的成員因潛在利益衝突而棄權)B Strength of consensus Consensus (0% of the group abstained due to potential Col) B 共識強度 共識(0% 的成員因潛在利益衝突而棄權)
Background 背景
Available evidence 現有證據
While the results from the meta-analysis (Teughels et al., 2020) revealed a statistically significantly improved outcome for systemically administrated antibiotics as an adjunct to subgingival debridement, the effect was confined to a limited group of antibiotics. A significantly improved PPD reduction at the 6-month follow-up was observed for metronidazole (MET) and amoxicillin (AMOX) n=8n=8; WMD =0.43,95%Cl=0.43,95 \% \mathrm{Cl} [0.36; 0.51]). Analysis of 12-month data revealed a significant adjunctive effect for MET + AMOX ( n=7n=7; WMD =0.54,95%Cl[0.33;0.74]=0.54,95 \% \mathrm{Cl}[0.33 ; 0.74] ) and MET ( n=2;WMD=0.26n=2 ; \mathrm{WMD}=0.26, 95%Cl[0.13;0.38])95 \% \mathrm{Cl}[0.13 ; 0.38]). The adjunctive use of MET + AMOX and MET resulted in a statistically significant additional percentage of pocket closure at 6 and 12 months. Statistically significantly greater CAL gain and BOP reduction for MET + AMOX at 6 and 12 months. The adjunctive effect of MET + AMOX on PPD reduction and CAL gain was more pronounced in initially deep than moderately deep pockets. There are no relevant data on the long-term (>12 months) effect of using systemic antibiotics as an adjunct to subgingival debridement. NNT was not assessed. 雖然統合分析結果(Teughels 等人,2020 年)顯示全身性抗生素作為齦下刮治輔助治療能顯著改善療效,但此效果僅限於特定抗生素種類。在 6 個月追蹤期觀察到,甲硝唑(MET)和阿莫西林(AMOX)能顯著增加探測牙周囊袋深度(PPD)的減少量( n=8n=8 ;加權平均差[WMD] =0.43,95%Cl=0.43,95 \% \mathrm{Cl} [0.36;0.51])。12 個月數據分析顯示 MET+AMOX( n=7n=7 ;WMD =0.54,95%Cl[0.33;0.74]=0.54,95 \% \mathrm{Cl}[0.33 ; 0.74] )與單獨使用 MET( n=2;WMD=0.26n=2 ; \mathrm{WMD}=0.26 , 95%Cl[0.13;0.38])95 \% \mathrm{Cl}[0.13 ; 0.38]) )具有顯著輔助效果。聯合使用 MET+AMOX 與 MET 能在 6 個月和 12 個月時顯著提高牙周囊袋閉合比例。MET+AMOX 組在 6 個月和 12 個月時呈現統計上顯著更高的臨床附著水平(CAL)增益與探診出血(BOP)減少率。MET+AMOX 對 PPD 減少與 CAL 增益的輔助效果在初始深牙周囊袋病例中比中度深囊袋更為明顯。目前缺乏關於全身性抗生素作為齦下刮治輔助治療的長期(>12 個月)效果數據。未進行需要治療人數(NNT)評估。
Risk of bias 偏誤風險
Low risk of bias and low heterogeneity among studies. 研究偏誤風險低且異質性低。
Consistency 一致性
High consistency of results. 結果高度一致。
Clinical relevance and effect size 臨床相關性與效應量
Effect size estimation on PPD reduction as opposed to subgingival debridement alone indicates an increased effect of about 40%-50%40 \%-50 \%. 相較於單純的牙齦下刮治,PPD 減少的效應量估計顯示效果增加約 40%-50%40 \%-50 \% 。
Balance of benefit and harm 利益與風險的平衡
While the MET + AMOX combination had the most pronounced effects on the clinical outcomes among the different types of systemic antimicrobial therapy, the regimen was also associated with the highest frequency of side effects. Global concerns regarding the overuse of antibiotics and the development of antibiotic resistance must be considered. Benefit versus harm analysis includes considerations on the overall use of antibiotics for the individual patient and public health. Systemic antibiotic regimens have shown long lasting impact on the faecal microbiome, including an increase in genes associated with antimicrobial resistance. 在不同類型的全身性抗菌治療中,MET + AMOX 組合對臨床結果的影響最為顯著,但該療法也伴隨著最高頻率的副作用。必須考量全球對於抗生素過度使用及抗藥性發展的擔憂。效益與風險分析需包含對個別患者及公共衛生整體抗生素使用的考量。全身性抗生素療法已顯示會對腸道微生物群產生長期影響,包括增加與抗菌劑抗藥性相關的基因。
Applicability 適用性
Due to concerns to patient’s health and the impact of systemic antibiotic use to public health, its routine use as adjunct to subgingival debridement in patients with periodontitis is not recommended. Based on the available evidence, however, its adjunctive use may be considered for special patient categories (e.g. generalized periodontitis Stage III in young adults). 基於對患者健康及全身性抗生素使用對公共衛生影響的考量,不建議常規性地將其作為牙周炎患者牙齦下刮治的輔助治療。然而根據現有證據,可考慮針對特殊患者類別(例如年輕成人的廣泛性第三期牙周炎)進行輔助性使用。
7 | CLINICAL RECOMMENDATIONS: THIRD STEP OF THERAPY 7 | 臨床建議:第三階段治療
The treatment of Stage III periodontitis should be carried out in an incremental manner, first by achieving adequate patient’s oral hygiene practices and risk factor control during the first step of therapy and then, during the second step of therapy by professional elimination (reduction) of supra and subgingival biofilm and calculus, with or without adjunctive therapies. However, in periodontitis patients, the complete removal of subgingival biofilm and calculus at teeth with deep probing depths ( >= 6mm\geq 6 \mathrm{~mm} ) or complex anatomical surfaces (root concavities, furcations, infra bony pockets) may be difficult, and hence, the endpoints of therapy may not be achieved, and further treatment should be implemented. 第三期牙周炎的治療應採取漸進式進行,首先在治療第一階段建立患者適當的口腔衛生習慣並控制風險因素,接著在第二階段由專業人員清除(或減少)齦上與齦下的生物膜和牙結石,可視情況搭配輔助療法。然而,對於牙周炎患者而言,在探測深度較深( >= 6mm\geq 6 \mathrm{~mm} )或具有複雜解剖結構(根面凹陷、分叉處、骨下袋)的牙齒上,要完全清除齦下生物膜和牙結石可能較為困難,因此可能無法達成治療目標,此時便需實施進一步治療。
The individual response to the second step of therapy should be assessed after an adequate healing period (periodontal re-evaluation). If the endpoints of therapy (no periodontal pockets > 4mm>4 \mathrm{~mm} with bleeding on probing or deep pockets [ >= 6mm][\geq 6 \mathrm{~mm}] ) have not been achieved, the third step of therapy should be implemented. If the treatment has been successful in achieving these endpoints of therapy, patients should be placed in a SPC program. 在足夠的癒合期後(牙周再評估),應評估患者對第二階段治療的個別反應。若未能達成治療目標(無探診出血的牙周囊袋 > 4mm>4 \mathrm{~mm} 或深層囊袋 [ >= 6mm][\geq 6 \mathrm{~mm}] ),則應實施第三階段治療。若治療已成功達成這些目標,患者應進入支持性牙周照護(SPC)計畫。
The third step of therapy is, therefore, aimed at treating those sites non-responding adequately to the second step of therapy with the purpose of getting access to deep pocket sites, or aiming at regenerating or resecting those lesions, that add complexity in the management of periodontitis (infrabony and furcation lesions). It may include the following interventions: 因此,治療的第三步驟旨在處理那些對第二步驟治療反應不佳的部位,目的是深入清潔深層牙周囊袋,或是針對那些增加牙周炎治療複雜性的病變(骨下缺損和分叉病變)進行再生或切除手術。可能包含以下介入措施:
Repeated subgingival instrumentation with or without adjunctive therapies 重複進行牙齦下刮治,可搭配輔助療法或單獨施行
Access flap periodontal surgery 開放瓣膜牙周手術
Resective periodontal surgery 切除性牙周手術
Regenerative periodontal surgery 牙周再生手術
Surgical approaches are subject to specific, additional patient consent and specific risk factors/presence of medical contra-indications should be considered. The individual response to the third step of therapy should be assessed (periodontal evaluation), and ideally, the endpoints of therapy should be achieved, and patients should be placed in SPC. These endpoints of therapy may not be achievable in all teeth in severe Stage III periodontitis patients. 手術方式需取得患者特別同意,並應考量特定風險因素或醫療禁忌症的存在。應評估患者對第三階段治療的個別反應(牙周評估),理想情況下應達成治療終點,並將患者納入支持性牙周照護(SPC)。對於嚴重的第三期牙周炎患者,並非所有牙齒都能達到這些治療終點。
The first relevant question to evaluate the relative efficacy of the surgical interventions in the third step of therapy, for the treatment of Stage III periodontitis patients with residual pockets after the second step of periodontal therapy, is whether access flap procedures are more efficacious than subgingival re-debridement for achieving the endpoints of therapy [probing depth (PD) <= 4mm\leq 4 \mathrm{~mm} without BOP]. 在第三階段治療中,針對第二階段牙周治療後仍有殘留牙周囊袋的第三期牙周炎患者,評估手術介入相對療效的首要問題是:就達到治療終點(探測深度[PD] <= 4mm\leq 4 \mathrm{~mm} 且無出血指數[BOP])而言,翻瓣手術是否比次齦下再清創更有效。
R3.1 | How effective are access flaps as compared to repeated subgingival instrumentation? R3.1 | 與重複次齦下器械治療相比,翻瓣手術的療效如何?
Evidence-based recommendation (3.1) 實證建議 (3.1)
In the presence of deep residual pockets (PPD >= 6mm\geq 6 \mathrm{~mm} ) in patients with Stage III periodontitis after the first and second steps of periodontal therapy, we suggest performing access flap surgery. In the presence of moderately deep residual pockets ( 4-5mm4-5 \mathrm{~mm} ), we suggest repeating subgingival instrumentation. 對於第三期牙周炎患者,在完成第一、二階段牙周治療後若仍存在深層殘留牙周囊袋(PPD >= 6mm\geq 6 \mathrm{~mm} ),我們建議進行開放瓣膜手術。若存在中度深層殘留牙周囊袋( 4-5mm4-5 \mathrm{~mm} ),則建議重複進行牙齦下器械治療。
Supporting literature Sanz-Sanchez et al. (2020) 支持文獻 Sanz-Sanchez 等人(2020 年)
Quality of evidence Thirteen RCTs (500 patients) with moderate-tohigh risk of bias. Five studies were restricted to pockets associated with intrabony defects. Limited number of studies presented data for quantitative analyses. High consistency of results. 證據品質 十三項隨機對照試驗(500 名患者)存在中高偏誤風險。其中五項研究僅針對伴隨骨內缺損的牙周囊袋。可供量化分析的數據研究數量有限,但結果呈現高度一致性。
Grade of recommendation Grade B- uarr\uparrow 推薦等級 B 級 uarr\uparrow
Strength of consensus Consensus (1.4% of the group abstained due to potential Col) 共識強度 共識(1.4%的成員因潛在利益衝突而棄權)
Background 背景
Available evidence 現有證據
Statistically significantly greater PPD reduction was observed in access flaps (AF) than in subgingival debridement at 1 year. The difference was more pronounced at initially deep sites (PPD >= 6mm\geq 6 \mathrm{~mm} ) (four studies, WMD =0.67,95%Cl=0.67,95 \% \mathrm{Cl} [0.37; 0.97], at 1 year; WMD = 0.39; 95% CI [0.09; 0.70]0.70] at > 1>1 year). The relative effect was 27.5%27.5 \%. These differences in PPD reduction also occurred in pockets associated with infrabony defects (four studies; WMD =0.49,95%Cl[0.11;0.86]=0.49,95 \% \mathrm{Cl}[0.11 ; 0.86] ). No statistically significant differences in CAL gain at initially deep pockets were observed between procedures. However, CAL gain was significantly greater in the subgingival debridement group at initially moderately deep pockets, and AF resulted in statistically significantly more attachment loss at sites with initial PPD <= 4mm\leq 4 \mathrm{~mm}. Statistically significantly higher percentage of shallow pockets was achieved with AF than with subgingival debridement (three studies, WMD = 11.6%, 95% CI [6.76; 16.5]). The need of re-treatment (four studies) was 8%-29%8 \%-29 \% in the subgingival debridement group and 0%-14%0 \%-14 \% in the AF. There were no statistically significant differences in PROMs between the interventions. 統計上顯著更大的牙周袋深度(PPD)減少在一年後觀察到,開放瓣清創術(AF)比牙齦下刮治更為明顯。這種差異在初始深度較深的部位(PPD >= 6mm\geq 6 \mathrm{~mm} )更為顯著(四項研究,加權平均差 =0.67,95%Cl=0.67,95 \% \mathrm{Cl} [0.37; 0.97],一年後;加權平均差 = 0.39;95% 信賴區間 [0.09; 0.70]0.70] , > 1>1 年後)。相對效應為 27.5%27.5 \% 。這些 PPD 減少的差異也出現在與骨下缺損相關的牙周袋中(四項研究;加權平均差 =0.49,95%Cl[0.11;0.86]=0.49,95 \% \mathrm{Cl}[0.11 ; 0.86] )。在初始深度較深的牙周袋中,兩種治療方式在臨床附著水平(CAL)增益方面未觀察到統計學上的顯著差異。然而,在初始中度深度的牙周袋中,牙齦下刮治組的 CAL 增益顯著更大,而 AF 在初始 PPD <= 4mm\leq 4 \mathrm{~mm} 的部位導致統計學上顯著更多的附著喪失。與牙齦下刮治相比,AF 達到統計學上顯著更高比例的淺牙周袋(三項研究,加權平均差 = 11.6%,95% 信賴區間 [6.76; 16.5])。再治療的需求(四項研究)在牙齦下刮治組為 8%-29%8 \%-29 \% ,在 AF 組為 0%-14%0 \%-14 \% 。兩種干預措施在患者報告結果指標(PROMs)方面沒有統計學上的顯著差異。
7.2 | Intervention: different access flaps procedures 7.2 | 治療方式:不同的開放瓣清創術程序
The second relevant question was whether there are specific surgical conservative surgical procedures that are more efficacious for 第二個相關問題是,是否存在特定的保守性手術程序能更有效地
achieving the endpoints of in the treatment of patients with Stage III periodontitis. 在第三期牙周炎患者的治療中達到預期效果。
Conservative surgical procedures have been defined as those aiming to access the affected root surfaces without eliminating significant amounts of hard and soft tissues. These procedures have been classified depending on the amounts of marginal gingiva and interdental papillary tissue removal into: 保守性手術程序被定義為旨在接觸受影響的牙根表面,而不大量移除硬組織和軟組織的手術方式。這些程序根據移除邊緣牙齦和牙間乳頭組織的量可分為:
open flap debridement with intra-sulcular incisions (OFD); 採用溝內切口的開放瓣清創術(OFD);
flaps with para-marginal incisions, such as modified Widman flap (MWF) and 帶有邊緣旁切口的皮瓣,例如改良威德曼皮瓣(MWF)和
papilla preservation flaps. 乳頭保留皮瓣。
R3.2 | How effective are the different access flap procedures? R3.2 | 不同類型的手術翻瓣程序效果如何?
Evidence-based recommendation (3.2) 實證基礎建議 (3.2)
In cases of deep (PPD >= 6mm\geq 6 \mathrm{~mm} ) residual pockets and intrabony defects in patients with Stage III periodontitis after adequate first and second steps of periodontal therapy, there is insufficient evidence for a recommendation on the choice of flap procedures. Access periodontal surgery can be carried out using different flap designs. 對於第三期牙周炎患者在接受完整的第一、二階段牙周治療後,仍存在深層(牙周囊袋深度≥5mm)殘留牙周囊袋及骨內缺損的情況,目前證據不足以對特定翻瓣手術的選擇做出建議。可採用不同設計的手術翻瓣方式進行牙周手術。
Supporting literature Sanz-Sanchez et al. (2020) 參考文獻 Sanz-Sanchez 等人 (2020)
Quality of evidence Three RCTs compared MWF with OFD. One RCT compared the efficacy of papilla preservation flaps (single flap approach versus OFD) in the presence of intrabony pockets. Two RCTs compared minimally invasive surgery with conventional surgery. Moderate to high risk of bias. Limited available data. 證據品質 有三項隨機對照試驗比較了改良威德曼翻瓣術(MWF)與開放性清創術(OFD)。其中一項試驗針對存在骨內袋的情況下,比較了乳頭保留瓣(單瓣法)與開放性清創術的療效。另有兩項試驗比較了微創手術與傳統手術。這些研究存在中度至高度偏倚風險,且可用數據有限。
Grade of recommendation Grade 0-harr0-\leftrightarrow 推薦等級 等級 0-harr0-\leftrightarrow
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 達成共識(0%小組成員因潛在利益衝突棄權)
Background 背景
Available evidence 現有證據
Out of three available studies comparing MWF with OFD, only one showed statistically significantly greater PPD reduction for MWF than OFD. There were no statistically significant differences in % PPD reduction in deep infrabony pockets between papilla preservation flap (single flap approach) and conventional flaps (one study). Two studies comparing minimally invasive surgery with conventional surgery did not demonstrate a significant added value in PPD reduction or CAL gain. 在三項比較改良威德曼翻瓣術與開放性清創術的研究中,僅有一項顯示改良威德曼翻瓣術在牙周探測深度(PPD)減少方面具有統計學上的顯著優勢。關於深層骨內袋治療,乳頭保留瓣(單瓣法)與傳統翻瓣術在牙周探測深度減少百分比方面未呈現統計學顯著差異(一項研究)。比較微創手術與傳統手術的兩項研究則顯示,兩者在牙周探測深度減少或臨床附著水平(CAL)增益方面並無顯著附加價值。
The third relevant question was whether resective flap procedures (those that, in addition to gaining access for subgingival debridement, 第三個相關問題是:切除性翻瓣手術(除了提供進入牙齦下清創的途徑外,
aim to change the architecture of the hard and/or the soft tissues to attain shallow probing depths) are more efficacious than conservative surgical procedures in achieving the endpoints of periodontal in the treatment of patients with Stage III periodontitis. 還旨在改變硬組織和/或軟組織的結構以達到淺探測深度)在治療第三期牙周炎患者時,是否比保守性手術更能有效達到牙周治療的終點。
R3.3 | What is the efficacy of pocket elimination/reduction surgery in comparison with access flap surgery? R3.3 | 與進入性翻瓣手術相比,牙周袋消除/縮減手術的療效如何?
Evidence-based recommendation (3.3) 實證建議(3.3)
In cases of deep (PPD >= 6mm\geq 6 \mathrm{~mm} ) residual pockets in patients with Stage III periodontitis after an adequate second step of periodontal therapy, we suggest using resective periodontal surgery, yet considering the potential increase of gingival recession. 對於第三期牙周炎患者在完成適當的第二階段牙周治療後,仍存在深層(PPD >= 6mm\geq 6 \mathrm{~mm} )殘留牙周袋的情況,我們建議採用牙周切除手術,但需考量可能增加牙齦退縮的風險。
Supporting literature Polak et al. (2020) 支持文獻 Polak 等人(2020)
Quality of evidence Nine RCTs (four could be used for the quantitative analysis). High risk of bias. Limited available data. 證據品質 九項隨機對照試驗(其中四項可用於定量分析)。高偏倚風險。現有數據有限。
Grade of recommendation Grade B- uarr\uparrow 建議等級 B 級- uarr\uparrow
Strength of consensus Simple majority ( 2.6%2.6 \% of the group abstained due to potential Col) 共識強度 簡單多數( 2.6%2.6 \% 的成員因潛在利益衝突而棄權)
Background 背景
Available evidence 現有證據
Resective periodontal surgery attained statistically significantly higher PPD reduction than access flaps at 6 months (WMD =0.59mm=0.59 \mathrm{~mm}; 95% Cl[0.06-1.12])\mathrm{Cl}[0.06-1.12]) and one year (WMD =0.47mm=0.47 \mathrm{~mm}; 95% Cl [0.24; 0.7]). For pockets 4-6mm4-6 \mathrm{~mm}, differences were statistically significant at 1 year (WMD =0.34mm=0.34 \mathrm{~mm}; 95% CI [0.19; 0.48]), while pockets 7 mm or deeper showed greater difference between the groups (WMD =0.76mm=0.76 \mathrm{~mm}; Cl [0.35; 1.17]). The differences were lost with time ( 3 - and 5 -year fol-low-up). There were no differences in CAL gains between the surgical modalities in the long term (3-5 years). Post-operative recession was statistically significantly greater following resective surgery than access flaps at 1-year post-op (two studies). No differences reported at 5-year follow-up (one study). No differences in recession over time in initially shallow pockets between the two modalities. 切除性牙周手術在 6 個月時(加權平均差 =0.59mm=0.59 \mathrm{~mm} ;95% Cl[0.06-1.12])\mathrm{Cl}[0.06-1.12]) )和 1 年時(加權平均差 =0.47mm=0.47 \mathrm{~mm} ;95%信賴區間[0.24; 0.7])比開放瓣手術獲得統計上顯著更高的牙周囊袋深度減少。對於 4-6mm4-6 \mathrm{~mm} 毫米的囊袋,差異在 1 年時具有統計顯著性(加權平均差 =0.34mm=0.34 \mathrm{~mm} ;95%信賴區間[0.19; 0.48]),而 7 毫米或更深的囊袋則顯示組間差異更大(加權平均差 =0.76mm=0.76 \mathrm{~mm} ;信賴區間[0.35; 1.17])。這些差異隨時間消失(3 至 5 年追蹤)。長期(3-5 年)來看,兩種手術方式在臨床附著水平獲得方面沒有差異。術後 1 年追蹤顯示(兩項研究),切除性手術後的牙齦退縮程度統計上顯著大於開放瓣手術。5 年追蹤時(一項研究)未報告差異。在初始淺囊袋中,兩種手術方式隨時間的退縮程度無差異。
Risk of bias 偏誤風險
High risk of bias, scarcity of quantitative data (only 4 RCTs). 高偏見風險,定量數據稀缺(僅 4 項隨機對照試驗)。
Clinical relevance and effect size 臨床相關性與效應量
The paucity of the data on percentage of shallow pockets or incidence of re-treatment prevents assessments of the clinical relevance of the differences. 關於淺牙周袋百分比或再治療發生率的數據不足,阻礙了對差異臨床相關性的評估。
Balance of benefit and harm 利益與風險的平衡
Data on PROMs, the percentage of residual pockets or the need of re-treatment were not reported in any of the studies. 任何研究均未報告患者報告結果指標(PROMs)、殘留牙周囊袋百分比或需要再治療的數據。
7.4 | General recommendations for periodontal surgical procedures 7.4 | 牙周手術程序的一般建議
R3.4 | What is the level of care required for management of deep residual pockets with or without presence of intrabony defects or furcation involvement after completion of steps 1 and 2 of periodontal therapy? R3.4 | 在完成牙周治療的第 1 和第 2 階段後,對於伴有或不伴有骨內缺損或分叉病變的深層殘餘牙周袋,需要何種程度的照護?
Surgical treatment is effective but frequently complex, and we recommend that it is provided by dentists with additional specific training or by specialists in referral centres. We recommend efforts to improve access to this level of care for these patients. 手術治療雖有效但通常較為複雜,我們建議應由受過額外專業訓練的牙醫師或轉診中心的專科醫師執行。我們建議應努力提升這類患者獲得此等級照護的可近性。
Supporting literature Expert opinion 支持文獻 專家意見
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 推薦等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 共識(0%的組員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Advanced periodontal surgery (regenerative and furcation management) is beyond the scope and competence of education in general dental practice (Sanz & Meyle, 2010). Dental curricula include knowledge and familiarity with the approach but are not designed to provide competence to conduct such treatment: Additional specific training is required and is available through continuing professional development and periodontal learned societies in most countries. Post-graduate periodontal education, on the other hand, is specifically designed to provide competence and proficiency towards the resolution of such complex problems (Sanz, van der Velden, van Steenberghe, & Baehni, 2006; Van der Velden & Sanz, 2010). 進階牙周手術(再生性治療與分叉病變處理)超出一般牙科執業教育範疇與能力範圍(Sanz & Meyle, 2010)。牙科課程雖包含相關知識與基礎操作訓練,但並未培養執行此類治療的專業能力:需透過持續專業進修及各國牙周病學會取得額外專門訓練。相對地,牙周病學研究生教育則專門培養解決此類複雜問題的專業能力(Sanz, van der Velden, van Steenberghe, & Baehni, 2006; Van der Velden & Sanz, 2010)。
R3.5 | If expertise is not available or referral is not an option, what is the minimum level of primary care required for management of residual pockets associated with or without intrabony defects or furcation involvement after completion of steps 1 and 2 of periodontal therapy? R3.5 | 若無專業資源或無法轉診,在完成牙周治療第 1、2 階段後,針對伴隨/不伴隨骨內缺損或分叉病變的殘餘牙周袋,基層照護所需的最低處置標準為何?
As a minimum requirement, we recommend repeated scaling and root debridement with or without access flap of the area in the context of high-quality step 1 and 2 treatment and a frequent program of supportive periodontal care including subgingival instrumentation. 作為最低要求,我們建議在高品質的第一階段與第二階段治療背景下,對該區域進行反覆的牙結石刮除與根面整平,並視情況搭配翻瓣手術,同時實施包含牙齦下器械治療的頻繁支持性牙周照護計畫。
Supporting literature Expert opinion [and systematic reviews for access flaps (Graziani et al., 2012, 2015)] 支持文獻 專家意見 [以及關於翻瓣手術的系統性文獻回顧(Graziani 等人,2012 年,2015 年)]
Strength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 共識(0%的組員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Dental services are organized differently in various countries. Some are structured in both primary care and specialist care (usually delivered by referral to dental hospitals or specialist practices/centres); in other countries, dental services are based on a single level of care and interested general practitioners acquire broader periodontal skills through continuing professional development. Optimal management of Stage III and Stage IV periodontitis remains limited in most health systems with significant inequalities in availability and access to advanced/specialist periodontal care. There is an urgent need to improve patient access to the appropriate level of care given the high burden and costs associated with the sequelae of unmanaged severe (stages III and IV) periodontitis. 各國的牙科服務組織方式有所不同。有些國家分為初級照護和專科照護(通常透過轉診至牙科醫院或專科診所/中心提供);在其他國家,牙科服務則基於單一層級照護,有興趣的一般牙醫師透過持續專業發展獲得更廣泛的牙周病治療技能。在大多數醫療體系中,第三期和第四期牙周病的最佳治療仍有限制,且高階/專科牙周照護的可用性與可近性存在顯著不平等。考慮到未受控制的嚴重(第三期和第四期)牙周病後遺症所帶來的高負擔與成本,迫切需要改善患者獲得適當照護的機會。
R3.6 | What is the importance of adequate selfperformed oral hygiene in the context of surgical periodontal treatment? R3.6 | 在牙周手術治療中,患者自我口腔清潔的重要性為何?
We recommend not to perform periodontal (including implant) surgery in patients not achieving and maintaining adequate levels of self-performed oral hygiene. 我們建議對於未能達到並維持適當自我口腔清潔水平的患者,不應進行牙周(包括植牙)手術。
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%的組員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Proof-of-principle studies conducted in the 1970s have pointed to the negative effects (clinical attachment loss) of performing periodontal surgery in subjects with inadequate plaque control (Nyman, Lindhe, & Rosling, 1977; Rosling, Nyman, Lindhe, & Jern, 1976). Multiple RCTs on surgical periodontal intervention have shown a dose-dependent effect of plaque control on healing outcomes. Similar data have been reported after implant surgery (van Steenberghe et al., 1990). The level of self-performed oral hygiene is clinically assessed using a plaque control record [for an example, see (O’Leary, Drake, & Naylor, 1972)]. Plaque scores smaller than 1970 年代進行的原理驗證研究指出,在牙菌斑控制不佳的受試者中進行牙周手術會產生負面效果(臨床附著喪失)(Nyman、Lindhe & Rosling,1977;Rosling、Nyman、Lindhe & Jern,1976)。多項關於牙周手術介入的隨機對照試驗顯示,牙菌斑控制對癒合效果具有劑量依賴性影響。植牙手術後也報告了類似數據(van Steenberghe 等人,1990)。自我口腔衛生水平是透過牙菌斑控制記錄進行臨床評估[範例可參見(O'Leary、Drake & Naylor,1972)]。牙菌斑分數低於 20%-25%20 \%-25 \% have been consistently associated with better surgical outcomes (see Step 1 and SPC clinical recommendations for detailed discussions on how to facilitate achieving stringent levels of selfperformed oral hygiene). 20%-25%20 \%-25 \% 的情況一致與較佳的手術結果相關(關於如何促進達成嚴格自我口腔衛生標準的詳細討論,請參見步驟 1 和 SPC 臨床建議)。
7.5 | Intervention: Management of intrabony defects 7.5 | 介入措施:骨內缺損處理
R3.7 | What is the adequate management of residual deep pockets associated with intrabony defects? R3.7 | 對於與骨內缺損相關的殘留深牙周袋,何種處置方式較為適當?
Evidence-based recommendation (3.7) 實證建議 (3.7)
We recommend treating teeth with residual deep pockets associated with intrabony defects 3 mm or deeper with periodontal regenerative surgery. 我們建議對與 3 毫米或更深骨內缺損相關的殘留深牙周袋牙齒,進行牙周再生手術治療。
Supporting literature Nibali et al. (2019) 參考文獻 Nibali et al. (2019)
Quality of evidence Twenty-two RCTs (1,182 teeth in 1,000 patients)-four studies at low risk of bias-there is consistency of direction of benefit but high heterogeneity for superiority of regeneration over open flap debridement. 證據品質 22 項隨機對照試驗(1,000 名患者的 1,182 顆牙齒)—其中 4 項研究偏見風險較低—顯示再生治療優於開放瓣清創術的效益方向一致,但存在高度異質性。
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 建議等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Consensus (10% of the group abstained due to potential Col) 共識強度 共識(10%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
See previous sections. An algorithm for clinical decision-making in the treatment by regenerative surgical therapy of intrabony defects and residual pockets is depicted in Figure 1. 請參閱前文。圖 1 展示了針對骨內缺損和殘留牙周袋進行再生手術治療的臨床決策演算法。
Available evidence 現有證據
The evidence base includes 22 RCTs with 1,000 patients. The quality of the evidence was rated as high. 證據基礎包含 22 項隨機對照試驗,共 1,000 名患者。證據品質被評定為高等級。
Risk of bias 偏誤風險
Study quality assessment identified four studies at low risk of bias and 15 studies at unclear risk of bias. 研究品質評估顯示,4 項研究具有低偏誤風險,15 項研究具有不明確的偏誤風險。
Consistency 一致性
Regenerative surgical therapy resulted in improved clinical outcomes (shallower pockets and higher CAL gain) compared with open flap debridement in the majority of studies. No indication of publication bias was observed. Moderate to substantial heterogeneity in the size of the adjunctive effect was observed. This could be partly explained by the use of specific biomaterials or flap designs. 在多數研究中,與開放瓣清創術相比,再生手術治療能改善臨床結果(較淺的牙周囊袋與更高的臨床附著獲得)。未觀察到發表偏誤的跡象。觀察到輔助效果大小存在中度至顯著的異質性,這可能部分歸因於特定生物材料或瓣膜設計的使用。
Clinical relevance and effect size 臨床相關性與效應量
The mean adjunctive benefit reported was 1.34 mm (95% Cl [0.95; 1.73]) in CAL gain and 1.20 mm ( 95%Cl95 \% \mathrm{Cl} [ 0.85 ; 1.55]) in pocket depth reduction. This represented an 80% (95% CI [60%; 100%]) 報告顯示輔助治療的平均效益為臨床附著水平(CAL)增加 1.34 毫米(95%信賴區間[0.95; 1.73])及牙周囊袋深度減少 1.20 毫米(95%信賴區間[0.85; 1.55])。此結果相較對照組呈現 80%(95%信賴區間[60%; 100%])的改善幅度。
improvement compared to the controls. A mean difference of this magnitude is deemed clinically relevant as it has the potential of decreasing risk of tooth loss. Observational and experimental studies reporting on tooth survival for a period of 3-20 years show improved tooth retention with periodontal regeneration in teeth under regular supportive periodontal therapy ( 28 RCTs summarized in Stavropoulos et al., 2020). 此等程度的平均差異被認為具有臨床意義,因其可能降低牙齒喪失風險。針對 3 至 20 年期間牙齒存活率的觀察性與實驗性研究顯示,在定期接受支持性牙周治療的牙齒中,配合牙周再生治療可提升牙齒保留率(Stavropoulos 等人 2020 年彙整的 28 項隨機對照試驗)。
Balance of benefit and harm 利益與風險的平衡
No serious adverse event was reported in any of the studies included in the systematic review. The adverse events associated with regenerative therapy included local adverse events (wound failure) and post-operative morbidity. No specific harm has been reported after regenerative surgery. Potential risk for disease transmission from well-documented human-derived or animal-derived regenerative biomaterials is considered extremely low. 系統性文獻回顧所納入的研究中,皆未報告任何嚴重不良事件。與再生療法相關的不良事件包括局部不良反應(傷口癒合不良)及術後不適症狀。再生手術後並未報告特定傷害案例。經完善紀錄的人源或動物源再生生物材料,其疾病傳播潛在風險被認為極低。
Ethical considerations 倫理考量
The perception that regenerative treatment of deep intrabony defects results in better outcomes than access flap is commonly held in the research and clinical community. Therefore, maximum tissue preservation flap with the application of documented regenerative biomaterials should be the standard of care. This perception is supported by the observation that only 22 of 79 RCTs included in the systematic review used access flap as the control and the majority of the body of evidence compared different regenerative techniques/ biomaterials. 在研究與臨床領域中,普遍認為針對深層骨內缺損進行再生治療的效果優於單純翻瓣手術。因此,採用具實證支持的再生生物材料並實施最大程度組織保留的翻瓣術,應成為標準治療方式。此觀點獲得系統性文獻回顧的支持——在納入的 79 篇隨機對照試驗中,僅有 22 篇以單純翻瓣術作為對照組,而多數研究證據皆聚焦於比較不同再生技術/生物材料的成效。
Regulatory consideration 法規考量
It is important to emphasise that only few classes of regenerative materials are registered in Europe. In each class, only few materials satisfy the evidence base criteria set forth by these guidelines and the considerations should not be applied to materials that have not been adequately tested. Implementation of the new EU medical device regulations will prove useful. 必須強調的是,在歐洲註冊的再生材料種類相當有限。在每一類材料中,僅有少數產品符合本指南所設立的實證標準,因此相關考量不應套用於未經充分測試的材料。歐盟新醫療器材法規的實施將對此有所助益。
Economic considerations 經濟考量
Regenerative surgery is more expensive than access flap surgery but cheaper than tooth replacement necessary as a consequence of tooth loss. In the absence of health-economic data in RCTs included in the review, a pilot study has indicated that the initial increase in cost of regeneration is associated with lower cost of managing recurrence over a 20-year period (Cortellini, Buti, Pini Prato, & Tonetti, 2017). 再生手術的費用雖高於翻瓣手術,但比因牙齒缺失而需進行的牙齒替代治療更為經濟。由於納入文獻回顧的隨機對照試驗缺乏健康經濟學數據,一項先導研究指出,再生治療初期增加的成本,與 20 年期間管理復發症狀的較低支出相關(Cortellini, Buti, Pini Prato, & Tonetti, 2017)。
Patient preferences 病患偏好
No data are available about patient preference or acceptability. Religious issues may be present for segments of the population since some of the regenerative materials are of porcine or bovine origin. While the use for medical reasons is generally acceptable and has been approved by religious leaders, the sensitivity of individual subjects may pose a barrier. 目前尚無關於患者偏好或接受度的相關數據。由於部分再生材料來源於豬或牛,可能涉及特定族群的宗教議題。雖然基於醫療目的使用通常可被接受,並已獲得宗教領袖認可,但個別受試者的敏感度仍可能構成障礙。
R3.8 | What is the adequate choice of regenerative biomaterials for promoting healing of residual deep pockets associated with a deep intrabony defect? R3.8 | 對於與深層骨內缺損相關的殘餘深牙周袋,促進癒合的適當再生性生物材料選擇為何?
Evidence-based recommendation (3.8) 實證基礎建議 (3.8)
In regenerative therapy, we recommend the use of either barrier membranes or enamel matrix derivative with or without the addition of bone-derived grafts* 在再生治療中,我們建議使用屏障膜或琺瑯基質衍生物,可選擇性添加骨源性移植材料*
Supporting literature Nibali et al. (2019) 參考文獻 Nibali et al. (2019)
Quality of evidence Twenty RCTs (972 patients)-four studies at low risk of bias-moderate-to-high heterogeneity for superiority of these biomaterials 證據品質 二十項隨機對照試驗(972 名患者)—其中四項研究偏見風險較低—這些生物材料在優越性方面呈現中度至高度異質性
The evidence base includes 20 RCTs with 972 patients. The quality of the evidence was considered to be high. 證據基礎包含 20 項隨機對照試驗,共 972 名患者。證據品質被評定為高水準。
Risk of bias 偏誤風險
Study quality assessment identified four studies at low risk of bias and 15 studies at unclear risk of bias. 研究品質評估發現 4 項研究具有低偏誤風險,15 項研究具有不明確的偏誤風險。
Consistency 一致性
Regenerative surgical therapy with a variety of biomaterials resulted in improved clinical outcomes compared with open flap debridement in the majority of studies. No indication of publication bias was observed. Moderate to substantial heterogeneity in the size of the adjunctive effect was observed. 在多數研究中,與開放瓣膜清創術相比,使用各種生物材料進行的再生手術治療能改善臨床結果。未觀察到出版偏誤的跡象。但觀察到輔助治療效果大小存在中度至顯著的異質性。
Clinical relevance and effect size 臨床相關性與效應量
The mean adjunctive benefit in term of CAL gain was 1.27 mm (95% CI [0.79; 1.74], equivalent to a 77% improvement) for EMD and 1.43 mm ( 95%Cl95 \% \mathrm{Cl} [ 0.76;2.220.76 ; 2.22 ], equivalent to an 86%86 \% improvement) for guided tissue regeneration (GTR) compared with OFD. 在臨床附著水平(CAL)增益方面,相較於開放性清創術(OFD),釉基質衍生物(EMD)的平均附加效益為 1.27 毫米(95%信賴區間[0.79; 1.74],相當於 77%的改善),而引導組織再生術(GTR)則為 1.43 毫米( 95%Cl95 \% \mathrm{Cl} [ 0.76;2.220.76 ; 2.22 ],相當於 86%86 \% 的改善)。
The combination of membrane with bone-derived graft resulted in higher CAL gain of 1.5 mm ( 95%Cl95 \% \mathrm{Cl} [ 0.66;2.340.66 ; 2.34 ], equivalent to a 90%90 \% improvement) compared with OFD. The comparison between EMD versus GTR resulted in no statistically significant difference in CAL gain. The choice of biomaterial or possible combinations should be based on defect configuration. 結合膜與骨骼來源移植物的治療方式,相較於開放性清創術(OFD)可獲得額外 1.5 毫米的臨床附著水平增益(95%信賴區間[0.9-2.1],相當於 90%90 \% 的改善)。比較牙釉質基質衍生物(EMD)與引導組織再生術(GTR)在臨床附著水平增益方面未達統計顯著差異。生物材料或可能組合的選擇應基於缺損形態進行考量。
R3.9 | What is the adequate choice of surgical flap design for the regenerative treatment of residual deep pockets associated with an intrabony defect? R3.9 | 針對伴隨骨內缺損的殘餘深牙周囊袋再生治療,何種手術瓣膜設計為適當選擇?
Evidence-based recommendation (3.9) 實證基礎建議(3.9)
We recommend the use of specific flap designs with maximum preservation of interdental soft tissue such as papilla preservation flaps. Under some specific circumstances, we also recommend limiting flap elevation to optimize wound stability and reduce morbidity. 我們建議採用能最大限度保留齒間軟組織的特殊瓣膜設計,例如乳頭保留瓣。在某些特定情況下,我們亦建議限制瓣膜抬升範圍以優化傷口穩定性並降低術後不適。
Supporting literature Graziani et al. (2012); Nibali et al. (2019) 支持文獻 Graziani 等人 (2012);Nibali 等人 (2019)
Quality of evidence Ancillary evidence arising from systematic reviews and expert opinion. 證據品質 來自系統性文獻回顧與專家意見的輔助證據
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 推薦等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Consensus ( 2.8%2.8 \% of the group abstained due to potential Col) 共識強度 共識( 2.8%2.8 \% 的團體成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文章節。
Available evidence 現有證據
The evidence base includes two systematic reviews. 證據基礎包含兩份系統性文獻回顧。
Risk of bias 偏誤風險
Study quality assessment identified five studies at low risk of bias and 15 studies at unclear risk of bias. 研究品質評估發現五項研究具有低偏差風險,十五項研究具有不明確的偏差風險。
Consistency 一致性
No conclusion can be drawn. 無法得出任何結論。
Clinical relevance and effect size 臨床相關性與效應量
Papilla preservation flaps have been shown to lead to increased CAL gain and PD reduction as well as reduced post-surgical recession compared with OFD. 乳頭保留瓣手術相較於開放式清創術(OFD),已證實能增加臨床附連增益(CLG)、降低牙周囊袋深度(PD),並減少術後牙齦退縮。
Balance of benefit and harm 利益與風險的平衡
No serious adverse event has been reported after application of papilla preservation flaps in regenerative periodontal surgery performed by adequately trained clinicians. The added complexity of the surgery requires additional training. 由受過充分訓練的臨床醫師執行再生性牙周手術時,採用乳頭保留瓣技術後尚未有嚴重不良事件報告。此手術的複雜性較高,需要額外的專業訓練。
Applicability 適用性
Anatomical considerations related to the width of the interdental space advise on the choice of the preferred flap design to access the interdental area (Cortellini, Prato, & Tonetti, 1995, 1999). Location and configuration of the intrabony defect advise on the possibility to (a) minimize flap extension (Cortellini & Tonetti, 2007; Harrel, 1999), and (b) raise a single flap or the need to fully elevate the interdental papilla (Cortellini & Tonetti, 2009; Trombelli, Farina, Franceschetti, & Calura, 2009). 根據齒間隙寬度的解剖學考量,可建議選擇最適合進入齒間區域的瓣膜設計(Cortellini, Prato, & Tonetti, 1995, 1999)。而骨內缺損的位置與形態則會影響:(a)最小化瓣膜延伸範圍的可能性(Cortellini & Tonetti, 2007; Harrel, 1999),以及(b)僅需掀起單側瓣膜或必須完整翻起齒間乳頭(Cortellini & Tonetti, 2009; Trombelli, Farina, Franceschetti, & Calura, 2009)。
7.6 | Intervention: Management of furcation lesions 7.6 | 介入措施:分叉病灶處理
R3.10 | What is the adequate management of molars with Class II and III furcation involvement and residual pockets? R3.10 | 對於具有第二類及第三類分叉病灶且殘留牙周囊袋的臼齒,應採取何種適當處置方式?
Evidence-based recommendation and statement (3.10) 實證建議與聲明 (3.10)
A We recommend that molars with Class II and III furcation involvement and residual pockets receive periodontal therapy. A 我們建議對具有第二類及第三類分叉病灶且殘留牙周囊袋的臼齒進行牙周治療。
B Furcation involvement is no reason for extraction. B 分叉處病變並非拔牙的理由。
Supporting literature Dommisch et al. (2020); Jepsen et al. (2019) 支持文獻 Dommisch et al. (2020); Jepsen et al. (2019)
A. Grade A- uarr uarr\uparrow \uparrow A. 等級 A- uarr uarr\uparrow \uparrow
B. Statement B. 聲明
A. Strength of consensus Strong consensus (1.5% of the group abstained due to potential Col) A. 共識強度 強烈共識(1.5%的成員因潛在利益衝突棄權)
B. Strength of consensus Consensus (1.5% of the group abstained due to potential Col) B. 共識強度 共識(1.5%的成員因潛在利益衝突棄權)
Consistency 一致性
Following treatment, moderate to substantial heterogeneity in the size of the effect (wide ranges of tooth survival) was observed. The reasons cannot be determined from the existing data. 治療後觀察到效果大小存在中度至顯著的異質性(牙齒存活率範圍廣泛)。現有數據無法確定其原因。
Clinical relevance and effect size 臨床相關性與效應量
Following treatment, reasonable survival rates were observed over 4-30.8 years. Overall, the observed tooth survival rates were better in Class II furcation involvement than Class III. 在接受治療後,觀察到 4 至 30.8 年間有合理的存活率。整體而言,觀察到第二類分叉病變的牙齒存活率優於第三類。
Balance of benefit and harm 利益與風險的平衡
We did not identify data about harm directly related to procedures. 我們未發現與治療程序直接相關的傷害數據。
Economic considerations 經濟考量
Simulations based on the German health system have indicated that tooth retention after complex periodontal therapy of teeth with furcation involvement is more cost-effective than their extraction and replacement with an implant supported fixed partial denture (Schwendicke, Graetz, Stolpe, & Dorfer, 2014). A study assessing the actual cost of retention of molars in the same health system showed that cost for retaining periodontally compromised molars were minimal (Schwendicke, Plaumann, Stolpe, Dorfer, & Graetz, 2016). 根據德國醫療體系的模擬研究顯示,對於有分叉病變的牙齒進行複雜牙周治療後保留牙齒,比拔牙後以植體支撐固定局部義齒替代更具成本效益(Schwendicke, Graetz, Stolpe, & Dorfer, 2014)。另一項評估同一醫療體系中臼齒保留實際成本的研究指出,保留受牙周病影響臼齒的成本極低(Schwendicke, Plaumann, Stolpe, Dorfer, & Graetz, 2016)。
Patient preferences 病患偏好
There is a strong patient preference for tooth retention (IQWiG, 2016). 患者普遍強烈傾向選擇保留牙齒(IQWiG, 2016)。
Applicability 適用性
The guideline can be applied since it is independent of availability of materials and a segment of the dental workforce has been trained or can be trained to deliver surgical furcation treatment in the different European health systems. 這份指引可適用於各種情況,因其不受限於材料取得問題,且歐洲各國醫療體系中已有部分牙科從業人員受過訓練或可接受培訓來執行手術性分叉病變治療。
R3.11 | What is the adequate management of residual deep pockets associated with mandibular Class II furcation involvement? R3.11 | 對於與下顎第二類分叉病變相關的殘留深牙周袋,何謂適當的處置方式?
Evidence-based recommendation (3.11) 實證建議 (3.11)
We recommend treating mandibular molars with residual pockets associated with Class II furcation involvement with periodontal regenerative surgery. 我們建議針對伴有第二類根分叉病變的殘留牙周囊袋之下顎臼齒,進行牙周再生手術治療。
Supporting literature Jepsen et al. (2019) 參考文獻 Jepsen 等人 (2019)
Quality of evidence 17 RCTs >= 12\geq 12 months (493 patients). 證據品質 17 項隨機對照試驗 >= 12\geq 12 個月 (493 名患者)。
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 推薦等級 A 級 - uarr uarr\uparrow \uparrow
Strength of consensus Consensus (7.6% of the group abstained due to potential Col) 共識強度 共識(7.6%的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention
See previous sections. 介入措施 請參閱前文章節。
Risk of bias 偏誤風險
High quality of evidence of RCTs. Low quality of evidence for observational studies. 隨機對照試驗證據品質高。觀察性研究證據品質低。
Background 背景
Intervention 介入措施
See previous sections. An algorithm for clinical decision-making in the treatment by periodontal surgery of molars with furcation involvement (Class I, Class II) and residual pockets is depicted in Figure 2. 請參閱前文。針對分叉病變(第一類、第二類)及殘餘牙周囊袋的牙周手術治療,其臨床決策演算法如圖 2 所示。
Available evidence 現有證據
The evidence base includes 20 RTCs with 575 patients (Class II buccal/lingual mandibular and maxillary buccal furcation involvement) and seven observational studies with 665 patients (Class II interproximal and Class III). Previous systematic reviews have addressed the clinical performance of periodontal therapy of teeth with furcation involvement (Huynh-Ba et al., 2009; Nibali et al., 2016). 證據基礎包含 20 項隨機對照試驗(共 575 名患者,研究下顎與上顎頰側/舌側第二類分叉病變)及 7 項觀察性研究(共 665 名患者,研究鄰接面第二類與第三類分叉病變)。先前系統性文獻回顧已探討分叉病變牙齒的牙周治療臨床效果(Huynh-Ba 等人,2009 年;Nibali 等人,2016 年)。
FIGURE 1 Regenerative surgical therapy of intrabony defects and residual pockets [Colour figure can be viewed at wileyonlinelibrary.com] 圖 1 骨內缺損與殘餘牙周袋的再生手術治療 [彩色圖片請參見 wileyonlinelibrary.com]
Available evidence 現有證據
The evidence base includes 17 RCTs with 493 patients. The quality of the evidence for the statement was assessed according to GRADE and considered to be high. In the systematic review underlying this recommendation (Jepsen et al., 2019), a standard meta-analysis grouping all regenerative techniques versus OFD was performed altogether with ancillary analysis. Results indicated that regenerative therapies had a significant benefit over OFD in terms of both primary and surrogate outcomes. 證據基礎包含 17 項隨機對照試驗,共 493 名患者。該聲明的證據品質根據 GRADE 系統評估,被認為是高品質的。在支持此建議的系統性文獻回顧中(Jepsen 等人,2019 年),進行了將所有再生技術與開放性清創術(OFD)進行分組的標準統合分析,並輔以輔助分析。結果顯示,無論是主要或替代性結果指標,再生療法都比 OFD 具有顯著優勢。
Risk of bias 偏誤風險
Study quality assessment identified an unclear risk of bias for the majority of the studies. Bearing in mind that six papers failed to disclose support and seven papers reported industry funding for the research. 研究品質評估發現多數研究存在不明確的偏誤風險。需特別注意的是,有六篇論文未披露資金來源,七篇論文報告了來自產業界的研究資助。
Consistency 一致性
Regenerative treatment consistently demonstrated added benefits (in terms of furcation improvement, horizontal bone gain, horizontal and vertical attachment gain, pocket reduction) in comparison with OFD. 與開放性清創術(OFD)相比,再生治療在分叉處改善、水平骨骼增益、水平與垂直附連增益、以及牙周囊袋深度減少等方面,均展現出持續性的附加效益。
Clinical relevance and effect size 臨床相關性與效應量
The mean adjunctive benefit of a regenerative treatment is clinically relevant ( 1.3 mm vertical CAL and greater PPD reduction), and the effect size is significant as furcation improvement showed an odds ratio (OR) of 21 (Bayesian credible interval 5.8-69.4) in favour of regenerative techniques. 再生治療的輔助效益平均值具有臨床意義(垂直臨床附著喪失改善 1.3 毫米及更顯著的牙周囊袋深度減少),其效果顯著,分叉病變改善的勝算比(OR)達 21(貝氏可信區間 5.8-69.4),顯示再生技術具有優勢。
Balance of benefit and harm 利益與風險的平衡
The benefit of regenerative therapies to promote tooth retention outweighs the adverse events which consist mainly of local wound failure. 促進牙齒保留的再生療法效益,主要優於可能發生的局部傷口癒合不良等不良事件。
Ethical considerations 倫理考量
The perception is that regenerative therapies to promote tooth retention are preferred over tooth extraction (and replacement) or open flap debridement. 普遍認為,相較於拔牙(及後續修復)或開放瓣清創術,促進牙齒保留的再生療法更受青睞。
Regulatory consideration 法規考量
All the studies reported FDA- or CE-approved devices. 所有研究報告皆使用食品藥物管理局或 CE 認證的設備。
Economic considerations 經濟考量
Regenerative surgery has additional costs, which appear to be justified by the added benefits (furcation improvements). 再生手術會產生額外費用,但這些費用似乎能由附加效益(分叉處改善)所合理化。
Patient preferences 病患偏好
Minimal data are available. 可獲得的數據極為有限。
Applicability 適用性
Teeth presenting with favourable patient, tooth and defect-related conditions. 符合患者條件、牙齒狀況及缺損相關有利因素的牙齒。
R3.12 | What is the adequate management of residual deep pockets associated with maxillary buccal Class II furcation involvement? R3.12 | 對於與上顎頰側第二類分叉病變相關的殘留深牙周袋,應採取何種適當的治療方式?
Evidence-based recommendation (3.12) 實證建議 (3.12)
We suggest treating molars with residual pockets associated with maxillary buccal Class II furcation involvement with periodontal regenerative surgery. 我們建議對與上顎頰側第二類分叉病變相關的殘留牙周袋臼齒,進行牙周再生手術治療。
Supporting literature Jepsen et al. (2019) 參考文獻 Jepsen 等人 (2019)
Quality of evidence Three RCTs >= 12\geq 12 months (82 patients). 證據品質 三項隨機對照試驗 >= 12\geq 12 個月(82 名患者)。
Grade of recommendation Grade B- uarr\uparrow 建議等級 B- 級 uarr\uparrow
Strength of consensus Consensus (8.5% of the group abstained due to potential Col) 共識強度 共識(8.5% 小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文。
Available evidence 現有證據
The evidence base includes three RCTs with 82 patients (Garrett et al., 1997; Hugoson et al., 1995; de Santana, Gusman, & Van Dyke, 1999). The quality of the evidence for the statement was assessed according to GRADE and considered to be moderate. Of these studies only one (de Santana et al., 1999) had a clear comparison towards OFD indicating an added benefit. 證據基礎包含 3 項隨機對照試驗,共 82 名患者(Garrett 等人,1997;Hugoson 等人,1995;de Santana、Gusman 與 Van Dyke,1999)。該聲明的證據品質根據 GRADE 系統評估,被認為屬於中等。這些研究中僅有一項(de Santana 等人,1999)明確與開放性清創術(OFD)進行比較,顯示出附加效益。
Risk of bias 偏誤風險
Study quality assessment identified an unclear/high risk of bias. 研究品質評估顯示存在不明確/高偏誤風險。
The benefit of regenerative therapies to promote tooth retention outweighs the adverse events which consist mainly of local wound failure. 再生療法促進牙齒保留的益處超過主要由局部傷口癒合不良所構成的不良事件。
Ethical considerations 倫理考量
The expert perception is that regenerative therapies to promote tooth retention are preferred over tooth extraction or open flap debridement. 專家認為,促進牙齒保留的再生療法優於拔牙或開放瓣清創術。
Regulatory consideration 法規考量
All the studies reported FDA- or CE-approved devices. 所有研究皆使用食品藥物管理局或 CE 認證的設備。
Economic considerations 經濟考量
Regenerative surgery has additional costs which appear to be justified by the added benefits (furcation improvements). 再生手術雖有額外成本,但因其附加效益(分叉處改善)而顯得合理。
Patient preferences 病患偏好
No data are reported. 未報告相關數據。
Applicability 適用性
Teeth presenting with favourable patient, tooth and defect-related conditions. 具備有利患者條件、牙齒條件及缺損相關條件的牙齒。
R3.13 | What is the adequate choice of regenerative biomaterials for the regenerative treatment of residual deep pockets associated with Class II mandibular and maxillary buccal furcation involvement? R3.13 | 針對與下顎及上顎頰側二級分叉病變相關的殘留深牙周囊袋,何種再生性生物材料適合用於再生治療?
We recommend treating molars with residual pockets associated with mandibular and maxillary buccal Class II furcation involvement with periodontal regenerative therapy using enamel matrix derivative alone or bone-derived graft with or without resorbable membranes* 我們建議使用單獨的琺瑯質基質衍生物,或搭配可吸收膜*的骨源性移植材料,對與下顎及上顎頰側二級分叉病變相關的殘留牙周囊袋臼齒進行牙周再生治療
Supporting literature Jepsen et al. (2019) 支持文獻 Jepsen 等人(2019 年)
Quality of evidence Seventeen RCTs >= 12\geq 12 months (493 patients) for mandibular class II, 3 RCTs >= 12\geq 12 months ( 82 patients) for maxillary buccal Class II, and support from indirect evidence, expert opinion. 證據品質 針對下顎第二類缺損,有 17 項隨機對照試驗(493 名患者) >= 12\geq 12 個月;針對上顎頰側第二類缺損,有 3 項隨機對照試驗(82 名患者) >= 12\geq 12 個月,並有間接證據與專家意見支持。
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 推薦等級 A 級 uarr uarr\uparrow \uparrow
FIGURE 2 Periodontal surgery: molars with furcation involvement (Classes II and III) and residual pockets [Colour figure can be viewed at wileyonlinelibrary.com] 圖 2 牙周手術:伴有根分歧病變(第二類與第三類)及殘餘牙周袋的臼齒 [彩色圖片可於 wileyonlinelibrary.com 查看]
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文。
Available evidence 現有證據
The evidence base includes 17 RCTs with 493 patients for mandibular Class II and three RCTs with 82 patients for maxillary buccal Class 證據基礎包含 17 項隨機對照試驗,共 493 名下顎第二類患者,以及 3 項隨機對照試驗,共 82 名上顎頰側第二類患者。
II. The quality of the evidence for the statement was assessed according to GRADE and considered to be high/moderate. In the systematic review underlying this recommendation (Jepsen et al., 2019), a Bayesian network meta-analysis was performed to assess which treatment modalities demonstrated the highest likelihood of success. For the outcome such as HBL, the highest-ranked groups were bone replacement graft, GTR with a bone replacement graft or enamel matrix derivative. 該聲明的證據品質根據 GRADE 系統評估為高/中等。在支持此建議的系統性文獻回顧中(Jepsen 等人,2019 年),採用了貝葉斯網絡統合分析來評估哪些治療方式具有最高的成功可能性。就 HBL 等結果而言,排名最高的組別為骨骼替代移植、搭配骨骼替代移植的引導組織再生術,或琺瑯基質衍生物。
Risk of bias 偏誤風險
Study quality assessment identified an unclear risk of bias for the majority of the studies. There is a mix of researcher and industryinitiated studies. 研究品質評估顯示,大多數研究存在不明確的偏誤風險。這些研究混合了研究人員主導和產業贊助的類型。
Consistency 一致性
The procedures with the highest ranking for horizontal bone gain are bone-replacement graft, bone-replacement graft with resorbable membranes or enamel matrix derivative. 在水平骨骼增量的治療方式中,排名最高的是骨骼替代移植、搭配可吸收膜的骨骼替代移植,以及琺瑯質基質衍生物。
Clinical relevance and effect size 臨床相關性與效應量
It cannot be extrapolated among the therapies. 無法在這些治療方式之間進行推論。
Balance of benefit and harm 利益與風險的平衡
The benefit of regenerative therapies to promote tooth retention outweighs the adverse events which consist mainly of local wound failure. 促進牙齒保留的再生療法所帶來的好處,遠超過主要由局部傷口癒合不良所構成的不良事件。
Ethical considerations 倫理考量
The perception is that regenerative therapies to promote tooth retention are preferred over tooth extraction and open flap debridement. 普遍認為促進牙齒保留的再生療法,優於拔牙與開放瓣膜清創術。
Regulatory consideration 法規考量
All the studies reported FDA- or CE-approved devices. 所有研究皆報告使用食品藥物管理局或 CE 認證的醫療器材。
Economic considerations 經濟考量
Regenerative surgery has additional costs, which appear to be justified by the added benefits (furcation improvements). 再生手術會產生額外費用,但這些費用似乎能因其帶來的附加效益(分叉處改善)而獲得合理補償。
Patient preferences 病患偏好
Enamel matrix derivative showed less postoperative swelling and pain than non-resorbable membranes. 與不可吸收膜相比,琺瑯基質衍生物能減少術後腫脹與疼痛感。
Applicability 適用性
Teeth presenting with favourable patient, tooth and defect-related conditions. 具備有利的患者條件、牙齒狀況及缺損相關條件的牙齒。
R3.14 | What is the adequate management of maxillary interdental Class II furcation involvement? R3.14 | 上顎牙間第二類分叉病變的適當處置方式為何?
Evidence-based recommendation (3.14) 實證建議 (3.14)
In maxillary interdental Class II furcation involvement non-surgical instrumentation, OFD, periodontal regeneration, root separation or root resection may be considered. 對於上顎牙間第二類分叉病變,可考慮採用非手術性器械治療、開放性清創術、牙周再生治療、牙根分離術或牙根切除術。
Supporting literature Dommisch et al. (2020); Huynh-Ba et al. (2009); Jepsen, Eberhard, Herrera, and Needleman, (2002) 參考文獻 Dommisch 等人 (2020);Huynh-Ba 等人 (2009);Jepsen、Eberhard、Herrera 和 Needleman (2002)
Quality of evidence Six observational studies (633 patients) with low quality of evidence for non-regenerative approaches and two systematic reviews with low quality of evidence for regenerative treatment. 證據品質 針對非再生性治療方法的六項觀察性研究(633 名患者)證據品質較低,以及兩項針對再生治療的系統性文獻回顧證據品質亦較低。
Grade of recommendation Grade 0-harr0-\leftrightarrow 建議等級 等級 0-harr0-\leftrightarrow
Strength of consensus Consensus (4.3% of the group abstained due to potential Col) 共識強度 共識 (4.3%的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文所述章節。
Available evidence 現有證據
Six observational studies with 633 patients (Class II interproximal). 六項觀察性研究,共 633 名患者(第二類鄰接面)。
Risk of bias 偏誤風險
Low quality of evidence for observational studies. 觀察性研究的證據品質較低。
Consistency 一致性
Following non-regenerative treatment of maxillary interproximal Class II furcation involvement, moderate to substantial heterogeneity in the size of the effect (wide ranges of tooth survival) was observed. The reasons cannot be determined from the existing data. 在上顎鄰接面第二類分叉缺損接受非再生性治療後,觀察到效果大小存在中度至顯著的異質性(牙齒存活率範圍廣泛)。現有數據無法確定原因。
Clinical relevance and effect size 臨床相關性與效應量
Following non-regenerative treatment of maxillary interproximal Class II furcation involvement, reasonable survival rates were observed over 4-30.8 years. 在上顎鄰接面第二類分叉缺損接受非再生性治療後,4 至 30.8 年間觀察到合理的存活率。
Balance of benefit and harm 利益與風險的平衡
We did not identify data about harm directly related to procedures. Regarding tooth survival, a benefit of root amputation/resection, root separation or tunnelling compared to SRP or OFD cannot be currently stated. For the individual choice of procedure, however, the clinician should consider criteria beyond class of furcation involvement (e.g. bone loss, jaw). 我們並未發現與治療程序直接相關的危害數據。關於牙齒存活率,目前尚無法斷言根切術/根切除術、根分離術或隧道成形術相較於刮治根面平整術(SRP)或開放式清創術(OFD)更具優勢。然而在選擇具體治療方式時,臨床醫師應考量除分叉病變分類外的其他標準(如骨骼缺損程度、頜骨狀況)。
Economic considerations 經濟考量
Simulations based on the German health system have indicated that tooth retention after complex periodontal therapy of teeth with furcation involvement is more cost-effective than their extraction and replacement with an implant supported fixed partial denture (Schwendicke et al., 2014). A study assessing the actual cost of retention of molars in the same health system showed that cost for retaining periodontally compromised molars were minimal (Schwendicke et al., 2016). 基於德國醫療體系的模擬研究顯示,對分叉病變牙齒進行複雜牙周治療後的保留,比拔除後以植體支持固定局部義齒修復更具成本效益(Schwendicke et al., 2014)。同一醫療體系中評估臼齒保留實際成本的研究指出,保留受牙周病影響臼齒的治療成本極低(Schwendicke et al., 2016)。
Patient preferences 病患偏好
There is a strong patient preference for tooth retention (IQWiG, 2016). 患者普遍強烈傾向保留自然牙(IQWiG, 2016)。
Applicability 適用性
The guideline can be applied since it is independent of availability of materials and a segment of the dental workforce has been trained or can be trained to deliver surgical furcation treatment in the different European health systems. 由於這份指南不受限於材料取得問題,且歐洲各國醫療體系中已有部分牙科人員受過訓練或可接受訓練來執行分叉處手術治療,因此可適用此指南。
R3.15 | What is the adequate management of maxillary Class III furcation involvement? R3.15 | 上顎第三類分叉處病變的適當處置方式為何?
Evidence-based recommendation (3.15) 實證建議 (3.15)
In maxillary Class III and multiple Class II furcation involvement in the same tooth nonsurgical instrumentation, OFD, tunneling, root separation or root resection may be considered. 對於上顎第三類分叉處病變及同一牙齒多處第二類分叉病變,可考慮採用非手術性器械清創、開放性皮瓣清創術、隧道成形術、牙根分離術或牙根切除術。
Supporting literature Dommisch et al. (2020) 支持文獻 Dommisch 等人 (2020)
Quality of evidence Six observational studies (633 patients) with low quality of evidence. 證據品質 六項觀察性研究(633 名患者)證據品質偏低。
Grade of recommendation Grade 0-harr0-\leftrightarrow 推薦等級 等級 0-harr0-\leftrightarrow
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文章節。
Available evidence 現有證據
Six observational studies with 633 patients. 六項觀察性研究,共 633 名患者。
Risk of bias 偏誤風險
Low quality of evidence for observational studies. 觀察性研究的證據品質較低。
Consistency 一致性
Following treatment of maxillary Class III furcation involvement, moderate to substantial heterogeneity in the size of the effect (wide ranges of tooth survival) was observed. The reasons cannot be determined from the existing data. 上顎第三類分叉病變治療後,觀察到效果大小存在中度至顯著的異質性(牙齒存活率範圍廣泛)。現有數據無法確定其原因。
Clinical relevance and effect size 臨床相關性與效應量
Following treatment of maxillary Class III furcation involvement, reasonable survival rates were observed over 4-30.8 years. 上顎第三類分叉病變治療後,在 4 至 30.8 年期間觀察到合理的存活率。
Balance of benefit and harm 利益與風險的平衡
We did not identify data about harm directly related to procedures. Regarding tooth survival, a benefit of root amputation/resection, root separation or tunnelling compared to SRP or OFD cannot be currently stated. For the individual choice of procedure, however, the clinician should consider criteria beyond class of furcation involvement (e.g. bone loss, jaw). 我們未發現與治療程序直接相關的傷害數據。關於牙齒存活率,目前無法斷言根切術/根切除術、根分離術或隧道成形術相較於刮治根面平整術(SRP)或開放性清創術(OFD)更具優勢。然而,臨床醫師在選擇個別治療程序時,應考量超越分叉病變分類的其他標準(例如骨骼缺損程度、頜骨狀況)。
Economic considerations 經濟效益考量
Simulations based on the German health system have indicated that tooth retention after complex periodontal therapy of teeth with furcation involvement is more cost-effective than their extraction and replacement with an implant supported fixed partial denture (Schwendicke et al., 2014). A study assessing the actual cost of retention of molars in the same health system showed that cost for retaining periodontally compromised molars were minimal (Schwendicke et al., 2016). 根據德國醫療體系進行的模擬顯示,對於分叉病變牙齒進行複雜牙周治療後的保留,比拔除後以植體支撐固定局部義齒替代更具成本效益(Schwendicke 等人,2014 年)。同一項針對該醫療體系中臼齒保留實際成本的研究表明,保留牙周受損臼齒的成本極低(Schwendicke 等人,2016 年)。
Patient preferences 病患偏好
There is a strong patient preference for tooth retention (IQWiG, 2016). 患者普遍強烈傾向保留原生牙齒(IQWiG,2016 年)。
Applicability 適用性
The guideline can be applied since it is independent of availability of materials and a segment of the dental workforce has been trained or can be trained to deliver resective treatment in the different European health systems. 由於該指南不受材料可用性限制,且歐洲各國醫療體系中已有部分牙科從業人員受過或可接受切除性治療的培訓,因此可適用此指南。
R3.16 | What is the adequate management of mandibular Class III furcation involvement? R3.16 | 下顎第三類分叉病變的適當處置方式為何?
In mandibular Class III and multiple Class II furcation involvement in the same tooth nonsurgical instrumentation, OFD, tunneling, root separation or root resection may be considered. 對於下顎第三類分叉病變及同一牙齒多處第二類分叉病變,可考慮採用非手術性器械治療、開放性清創術、隧道成形術、牙根分離術或牙根切除術。
Supporting literature Dommisch et al. (2020) 支持文獻 Dommisch 等人 (2020)
Quality of evidence Seven observational studies (665 patients) with low quality of evidence. 證據品質 七項觀察性研究(665 名患者),證據品質低。
Grade of recommendation Grade 0-harr0-\leftrightarrow 推薦等級 等級 0-harr0-\leftrightarrow
Strength of consensus Unanimous consensus (0% of the group abstained due to potential Col) 共識強度 全體一致共識(0%的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文。
Available evidence 現有證據
Seven observational studies with 665 patients (with mandibular class III furcation). 七項觀察性研究,共 665 名患者(患有下顎第三類分叉病變)。
Risk of bias 偏誤風險
Low quality of evidence for observational studies. 觀察性研究的證據品質較低。
Consistency 一致性
Following treatment mandibular Class III furcation involvement, moderate to substantial heterogeneity in the size of the effect (wide ranges of tooth survival) was observed. The reasons cannot be determined from the existing data. 在治療下顎第三類分叉病變後,觀察到效果大小的中度至顯著異質性(牙齒存活率的範圍廣泛)。現有數據無法確定原因。
Clinical relevance and effect size 臨床相關性與效果大小
Following treatment of mandibular Class III furcation involvement, reasonable survival rates were observed over 4-30.8 years. 在下顎第三類分叉病變治療後,觀察到 4 至 30.8 年間具有合理的存活率。
Balance of benefit and harm 利益與風險的平衡
We did not identify data about harm directly related to procedures. Regarding tooth survival a benefit of root amputation/resection, root separation or tunnelling compared to SRP or OFD cannot be currently stated. For the individual choice of procedure, however, the clinician should consider criteria beyond class of furcation involvement (e.g. bone loss, jaw). 我們並未發現與治療程序直接相關的傷害數據。關於牙齒存活率,目前無法斷言根切術/根切除術、根分離術或隧道形成術相較於刮治根面平整術(SRP)或開放性清創術(OFD)更具優勢。然而,臨床醫師在選擇治療方式時,應考量超出分叉病變分類的其他標準(例如骨骼缺損程度、所屬顎骨)。
Economic considerations 經濟效益考量
Simulations based on the German health system have indicated that tooth retention after complex periodontal therapy of teeth with furcation involvement is more cost-effective than their extraction and replacement with an implant supported fixed partial denture (Schwendicke et al., 2014). A study assessing the actual cost of retention of molars in the same health system showed that cost for retaining periodontally compromised molars were minimal (Schwendicke et al., 2016). 基於德國醫療體系的模擬研究顯示,對於涉及分叉病變的牙齒進行複雜牙周治療後的保留,比拔除後以植體支持固定局部義齒取代更具成本效益(Schwendicke et al., 2014)。同一醫療體系中評估臼齒保留實際成本的研究表明,保留受牙周病影響臼齒的花費極低(Schwendicke et al., 2016)。
Patient preferences 病患偏好
There is a strong patient preference for tooth retention (IQWiG, 2016). 患者普遍強烈傾向保留牙齒(IQWiG,2016 年)。
Applicability 適用性
The guideline can be applied since it is independent of availability of materials and a segment of the dental workforce has been trained or can be trained to deliver resective treatment in the different European health systems. 本指南具有適用性,因其不受材料供應限制,且歐洲各醫療體系中已有部分牙科從業人員受過或可接受培訓以執行切除性治療。
8 | CLINICAL RECOMMENDATIONS: SUPPORTIVE PERIODONTAL CARE 8 | 臨床建議:牙周支持性照護
Following completion of active periodontal therapy, successfully treated periodontitis patients may fall in one of two diagnostic categories: periodontitis patients with a reduced but healthy periodontium or periodontitis patients with gingival inflammation (Caton et al., 2018; Chapple et al., 2018). These subjects remain at high risk for periodontitis recurrence/progression and require specifically designed supportive periodontal care (SPC), consisting on a combination of preventive and therapeutic interventions rendered at different intervals which should including: appraisal and on monitoring of systemic and periodontal health, reinforcement of oral hygiene instructions, patient motivation towards continuous risk factor control, professional mechanical plaque removal (PMPR) and localized subgingival instrumentation at residual pockets. The professional interventions, also frequently referred as periodontal maintenance or supportive periodontal therapy, will require a structured recall system with visits customized to the patient needs, usually requiring 45- to 60-min appointments. SPC 在完成積極性牙周治療後,成功治療的牙周炎患者可能歸屬於兩種診斷類別之一:具有縮減但健康的牙周組織之牙周炎患者,或伴有牙齦發炎的牙周炎患者(Caton 等人,2018;Chapple 等人,2018)。這些個案仍具有牙周炎復發/進展的高風險,需要特別設計的支持性牙周照護(SPC),包含以不同間隔實施的預防性與治療性介入措施組合,應包括:評估與監測全身及牙周健康狀態、加強口腔衛生指導、激勵患者持續控制風險因子、專業機械性牙菌斑清除(PMPR)以及對殘留牙周囊袋進行局部性齦下器械處理。此類專業介入措施,亦常被稱為牙周維護或支持性牙周治療,需建立結構化的回診系統,根據患者需求客製化訪視安排,通常每次約診需 45 至 60 分鐘。SPC
also includes individual behaviours, since patients in SPC should be compliant with the recommended oral hygiene regimens and healthy lifestyles. 同時也包含個人行為,因為接受支持性牙周照護(SPC)的患者應遵守建議的口腔衛生習慣與健康生活方式。
We recommend that supportive periodontal care visits should be scheduled at intervals of 3 to a maximum of 12 months and ought to be tailored according to patient’s risk profile and periodontal conditions after active therapy. 我們建議支持性牙周照護的回診間隔應設定為 3 至最多 12 個月,並應根據患者的主動治療後風險狀況和牙周狀況進行調整。
Supporting literature Polak et al. (2020), Ramseier et al. (2019), Sanz et al. (2015), Trombelli et al. (2020), Trombelli et al. (2015) 支持文獻 Polak 等人(2020 年)、Ramseier 等人(2019 年)、Sanz 等人(2015 年)、Trombelli 等人(2020 年)、Trombelli 等人(2015 年)
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 推薦等級 等級 A- uarr uarr\uparrow \uparrow
Strength of consensus Strong consensus ( 0%0 \% of the group abstained due to potential Col) 共識強度 強烈共識( 0%0 \% 的團體成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Although not addressed directly in the systematic reviews underlying this guideline, different evidence supports the concept of defined intervals to perform SPC visit every 3-4 months are recommended in studies selected by Trombelli et al. (2020). 雖然本指南所依據的系統性文獻回顧未直接提及此點,但 Trombelli 等人(2020 年)所選研究中提出的不同證據支持每 3-4 個月進行一次支持性牙周照護回診的明確間隔概念。
SPC every 3 months may be sufficient to control periodontitis progression after periodontal surgery (Polak et al., 2020). 每 3 個月進行一次牙周支持治療(SPC)可能足以控制牙周手術後的病情進展(Polak 等人,2020 年)。
In addition, the conclusions of the 2014 European Workshop on Prevention, based on the review by Trombelli et al. (2015), concluded that the recommended interval ranges 2-4 times per year and that it could be optimized if it is tailored according to patient’s risk (Sanz et al., 2015). 此外,2014 年歐洲預防研討會根據 Trombelli 等人(2015 年)的文獻回顧得出結論,建議每年進行 2-4 次支持治療,若能根據患者風險程度調整頻率可達到最佳效果(Sanz 等人,2015 年)。
A recent study (Ramseier et al., 2019), over 883 patients, reflected on the importance of SPC and the factors involved in its success. 一項針對 883 名患者的最新研究(Ramseier 等人,2019 年)探討了牙周支持治療的重要性及其成功關鍵因素。
R4.2 | Is adherence to supportive periodontal care important? R4.2 | 遵守牙周支持治療計畫是否重要?
We recommend that adherence to supportive periodontal care should be strongly promoted, since it is crucial for long-term periodontal stability and potential further improvements in periodontal status. 我們強烈建議應積極推廣支持性牙周照護的遵從性,因為這對於長期牙周穩定性及潛在的牙周狀況進一步改善至關重要。
Supporting literature Costa et al. (2014), Sanz et al. (2015), Trombelli et al. (2015) 支持文獻 Costa 等人 (2014)、Sanz 等人 (2015)、Trombelli 等人 (2015)
Strength of consensus Unanimous consensus (0% of the group abstained due to potential Col) 共識強度 全體一致共識(0%小組成員因潛在 Col 因素棄權)
Background 背景
Intervention 介入措施
Although not addressed directly in the systematic reviews underlying this guideline, different evidence supports the importance of complying with SPC visit, in which PMPR is performed: 雖然本指南所依據的系統性文獻回顧並未直接探討此議題,但不同證據均支持遵守 SPC 回診(進行 PMPR 治療)的重要性:
Greater rates of tooth loss and disease progression in patients with irregular compliance, versus patients with regular compliance (Costa et al., 2014). 與定期回診的患者相比,未規律回診的患者有更高的牙齒喪失率及疾病惡化風險(Costa 等人,2014 年研究)。
The conclusions of the 2014 European Workshop on Prevention, based on the review by Trombelli et al. (2015), concluded that compliance with the preventive professional intervention is crucial, based also on retrospective observational studies (Sanz et al., 2015). 2014 年歐洲預防研討會根據 Trombelli 等人(2015 年)的文獻回顧得出結論,基於回溯性觀察研究(Sanz 等人,2015 年),遵守專業預防性介入措施至關重要。
8.2 | Intervention: Supragingival dental biofilm control (by the patient) 8.2 | 介入措施:患者自我執行之齦上牙菌斑控制
R4.3 | Are oral hygiene instructions important? How should they be performed? R4.3 | 口腔衛生指導是否重要?應如何執行?
We recommend repeated individually tailored instructions in mechanical oral hygiene, including interdental cleaning, in order to control inflammation and avoid potential damage for patients in periodontal SPC. 我們建議針對牙周支持性治療期患者,重複提供個別化的機械式口腔衛生指導(包含牙縫清潔),以控制發炎並避免潛在傷害。
Supporting literature Slot et al. (2020) 支持文獻 Slot 等人(2020)
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 推薦等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Unanimous consensus (0% of the group abstained due to potential Col) 共識強度 全體一致共識(0% 小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
All surfaces exposed to the formation of intraoral biofilm have to be cleaned mechanically. Some of them will not be reached by toothbrushes even under optimized conditions. Interproximal cleaning therefore is essential in order to maintain interproximal gingival health, in particular for secondary prevention. It may be achieved using different devices, primarily inter-dental brushes (IDB, which are not single-tufted brushes), rubber/elastomeric cleaning sticks, wood sticks, oral irrigators and floss. However, all devices have the potential of side effects and their use has to be monitored not only with respect to efficacy but also with respect to early signs of trauma (e.g. onset of non-carious cervical lesions). 所有暴露於口腔內生物膜形成的表面都必須進行機械性清潔。即使在最佳條件下,有些區域仍無法被牙刷觸及。因此,鄰接面清潔對於維持鄰接面牙齦健康至關重要,特別是針對次級預防。這可透過不同工具達成,主要包括牙間刷(IDB,非單束刷)、橡膠/彈性清潔棒、木棒、口腔沖洗器及牙線。然而,所有工具都可能產生副作用,使用時不僅需監測其效果,還需注意創傷的早期徵兆(例如非齲性頸部病變的出現)。
Available evidence 現有證據
Due to the scarcity of studies that met the inclusion criteria for each of the oral hygiene devices and the low certainty of the resultant evidence, no strong “evidence based” conclusion can be drawn concerning any specific oral hygiene device for patient self-care in periodontal maintenance. The evidence that emerged from the search provided 16 papers reporting on 13 CCTs/RCTs, which included 17 comparisons. The differences of powered versus manual toothbrushes were evaluated in five comparisons, an interdental device was used as an adjunct to toothbrushing in five comparisons, and seven comparisons evaluated two different interdental devices. In total, the studies evaluated 607 patients. 由於符合納入標準的口腔清潔裝置研究數量稀少,且所得證據的確定性較低,因此無法針對牙周維護期患者自我照護的任何特定口腔清潔裝置得出強有力的「實證基礎」結論。檢索結果顯示共有 16 篇論文報告了 13 項 CCTs/RCTs 研究,包含 17 組比較。其中 5 組比較評估了電動牙刷與手動牙刷的差異,5 組比較將牙間清潔裝置作為刷牙輔助工具,另有 7 組比較評估了兩種不同牙間清潔裝置的效果。總計這些研究共評估了 607 名患者。
Risk of bias 偏誤風險
Study quality assessment identified one study at low risk of bias and 10 studies at high risk and two of an unclear risk of bias. 研究品質評估顯示,1 項研究具有低偏差風險,10 項研究具有高偏差風險,2 項研究的偏差風險尚不明確。
Consistency 一致性
The summary of findings table shows that the body of evidence is rather consistent. 研究結果摘要表顯示,整體證據具有相當程度的一致性。
Clinical relevance and effect size 臨床相關性與效應量
Variable, depending on the comparisons established. 結果會因所建立的比較組別而有所差異。
Balance of benefit and harm 利益與風險的平衡
The adverse events were not evaluated. There is a moderate risk of trauma due to the use of interdental cleaning devices, when not used properly. Therefore, individual instruction and adoption to the individual situation by professionals are crucial. In any case, the benefits overweigh the risks by far. 並未評估不良事件。若未正確使用牙間清潔工具,存在中度創傷風險。因此,專業人員的個別指導與依個人情況調整至關重要。無論如何,其效益遠大於風險。
Economic considerations 經濟效益考量
A manual toothbrush is less expensive than a power toothbrush. Interdental brushes and oral irrigators are more expensive than dental floss, wood sticks and rubber and silicon interdental bristle cleaners. 手動牙刷比電動牙刷便宜。牙間刷與口腔沖洗器比牙線、木質牙籤及橡膠/矽膠牙間清潔工具更昂貴。
Patient preferences 病患偏好
No data on patient preference arrive from the current review. 本次回顧未取得患者偏好的相關數據。
Applicability 適用性
The guideline can be applied to patients attending a periodontal maintenance program. There is an abundance of mechanical oral hygiene products available. 本指南適用於參與牙周維護計畫的患者。現有大量機械式口腔清潔產品可供選擇。
R4.4 | How should we choose an appropriate design of manual, powered toothbrushes and interdental cleaning devices? R4.4 | 我們應如何選擇合適的手動、電動牙刷及齒間清潔裝置的設計?
We recommend taking into account patients’ needs and preferences when choosing a toothbrush design, and when choosing an interdental brush design. 我們建議在選擇牙刷設計和牙間刷設計時,應考量患者的需求與偏好。
Strength of consensus Strong consensus ( 6.9%6.9 \% of the group abstained 共識強度 強烈共識( 6.9%6.9 \% 的成員棄權)
due to potential Col ) 由於潛在的 Col 因素
Expert consensus-based recommendation (4.4)
Supporting literature Slot et al. (2020)
Grade of recommendation Grade A-uarr uarr
Strength of consensus Strong consensus ( 6.9% of the group abstained
due to potential Col )| Expert consensus-based recommendation (4.4) |
| :--- |
| Supporting literature Slot et al. (2020) |
| Grade of recommendation Grade $\mathrm{A}-\uparrow \uparrow$ |
| Strength of consensus Strong consensus ( $6.9 \%$ of the group abstained |
| due to potential Col ) |
Background 背景
Intervention 介入措施
See previous section. 請參閱前一節。
Available evidence 現有證據
Scarcity or a lack of evidence does not necessarily imply that products may not be effective. Dental care professionals in clinical practice should tailor the best oral hygiene devices and methods according to patients’ skill levels and preferences because patient acceptance is crucial for sustained long-term use (Steenackers, Vijt, Leroy, De Vree, & De Boever, 2001). Clinical evidence indicates that the efficacy of interdental brushes depends on the relation between the size of the brush and the size and shape of the interdental space. Interdental spaces underlay a high variety regarding size and morphology, and interdental brushes have to be selected specific to the individual interdental space. The number of devices has to be limited to a certain number with respect to the ability of the patient to cope with this diversity. To reach this goal, compromises have to be found to achieve the individual optimum. 缺乏證據或證據不足並不必然意味著產品可能無效。臨床執業的牙科護理專業人員應根據患者的技能水平和偏好,量身定制最佳的口腔衛生工具和方法,因為患者的接受度對於長期持續使用至關重要(Steenackers, Vijt, Leroy, De Vree, & De Boever, 2001)。臨床證據顯示,牙間刷的效果取決於刷子尺寸與牙間隙大小及形狀的匹配程度。牙間隙在大小和形態上存在高度多樣性,因此必須根據個別牙間隙的具體情況選擇合適的牙間刷。考慮到患者應對這種多樣性的能力,使用的工具數量必須限制在一定範圍內。為實現這一目標,需要找到折衷方案以達到個體最佳效果。
R4.5 | Should we recommend a powered or a manual toothbrush? R4.5 | 我們應該推薦電動牙刷還是手動牙刷?
Evidence-based recommendation (4.5) 實證基礎建議(4.5)
The use of a powered toothbrush may be considered as an alternative to manual tooth brushing for periodontal maintenance patients. 對於牙周維護期患者,可考慮使用電動牙刷作為手動刷牙的替代方案。
Supporting literature Slot et al. (2020) 支持文獻 Slot 等人 (2020)
Quality of evidence Five RCTs (216 patients) with high risk of bias 證據品質 五項隨機對照試驗(216 名患者)存在高偏倚風險
Grade of recommendation Grade 0-harr0-\leftrightarrow 推薦等級 等級 0-harr0-\leftrightarrow
Strength of consensus Strong consensus (22.5% of the group abstained due to potential Col) 共識強度 強烈共識(22.5%小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文段落。
Available evidence 現有證據
Based on the evidence from the systematic reviews underlying this guideline, toothbrushing is effective in reducing levels of dental plaque (Van der Weijden & Slot, 2015). Toothbrushes vary in size, design and the length, hardness and 根據本指南所依據的系統性文獻回顧證據,刷牙能有效減少牙菌斑堆積(Van der Weijden & Slot, 2015)。牙刷在尺寸、設計以及刷毛長度、硬度與...
arrangement of the bristles. Some manufacturers have claimed superiority in modifications such as bristle placement, length and stiffness. Powered toothbrushes with various mechanical motions and features are available. The evidence that emerged from the search provided eight papers describing five CCT/RCT comparisons. In total, the studies evaluated 216 patients. The quality of the evidence for the statement was assessed according to GRADE. 刷毛的排列方式。部分製造商聲稱在刷毛位置、長度與硬度等改良設計上具有優勢。市面上可購得具備各種機械動作與功能的電動牙刷。檢索結果顯示共有 8 篇論文描述 5 組 CCT/RCT 比較研究,總計納入 216 名患者進行評估。該聲明的證據品質係依據 GRADE 標準進行評定。
Risk of bias 偏誤風險
Study quality assessment showed that all studies at high risk of bias. 研究品質評估顯示所有研究皆存在高偏誤風險。
Consistency 一致性
The summary of findings table shows that the body of evidence is rather consistent. 研究結果摘要表顯示證據主體相當一致。
Clinical relevance and effect size 臨床相關性與效應量
No differences could be found. The statistically established clinical evidence was calculated for one study and showed no clinically relevant effect size. 未發現顯著差異。針對單一研究進行的統計學臨床證據分析顯示,其效果量未達臨床相關標準。
Balance of benefit and harm 利益與風險的平衡
The adverse events were not evaluated. 未評估不良事件。
Economic considerations 經濟效益考量
A manual toothbrush is less expensive than a power toothbrush. 手動牙刷比電動牙刷便宜。
Patient preferences 病患偏好
No data on patient preference arrive from the current review. 目前審查中未取得關於患者偏好的數據。
Applicability 適用性
The guideline can be applied to patients attending a periodontal maintenance program. There is an abundance of toothbrushes available. 本指南適用於參與牙周維護計劃的患者。市面上有大量牙刷可供選擇。
R4.6 | How should interdental cleaning be performed? R4.6 | 如何進行牙間清潔?
Evidence-based recommendation (4.6) 實證建議(4.6)
If anatomically possible, we recommend that tooth brushing should be supplemented by the use of interdental brushes. 若解剖結構允許,我們建議在刷牙之外應輔以牙間刷的使用。
Supporting literature Slot et al. (2020) 支持文獻 Slot 等人 (2020)
Quality of evidence Seven comparisons from four RCTs (290 patients) with low to unclear risk of bias 證據品質 來自四項隨機對照試驗(290 名患者)的七項比較結果,其偏誤風險為低至不明確
Grade of recommendation Grade A- uarr uarr\uparrow \uparrow 推薦等級 等級 A- uarr uarr\uparrow \uparrow
Strength of consensus Unanimous consensus (5.4% of the group abstained due to potential Col) 共識強度 全體一致共識(5.4%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文。
Available evidence 現有證據
The underlying systematic review (Slot et al., 2020) found evidence for a significantly better cleaning effect of interdental cleaning devices as adjuncts to tooth brushing alone, and a significantly better cleaning effect of interdental brushes than of flossing. Both the descriptive analysis and the NMA indicate that IDBs are the first choice for periodontal maintenance patients. Seven comparisons from four RCTs (290 patients) were identified. 基礎系統性回顧(Slot 等人,2020 年)發現,作為單獨刷牙的輔助工具,牙間清潔裝置具有顯著更好的清潔效果,且牙間刷的清潔效果顯著優於牙線。描述性分析和網絡統合分析均表明,牙間刷是牙周維護患者的首選。共識別出來自四項隨機對照試驗(290 名患者)的七項比較。
Risk of bias 偏誤風險
Low to unclear. 低至不明確。
Consistency 一致性
High. 高。
Clinical relevance and effect size 臨床相關性與效應量
Considered as clinically relevant. 視為具有臨床相關性。
Balance of benefit and harm 利益與風險的平衡
There is a moderate risk of trauma due to the use of interdental brushes, when not used properly. Therefore, individual instruction and adaptation to the individual situation by professionals are crucial. In any case, the benefits overweigh the risks by far. 若未正確使用牙間刷,存在中度創傷風險。因此,專業人員的個別指導與情境適應至關重要。無論如何,其效益遠超過風險。
Economic considerations 經濟效益考量
Not considered. 不予考慮。
Patient preferences 病患偏好
There is clinical evidence supporting that patients with open interdental spaces prefer the use of interdental brushes over the use of dental floss. 臨床證據顯示,對於具有牙間隙的患者,使用牙間刷的偏好度高於使用牙線。
Applicability 適用性
The guideline can be applied since appropriate quantities and varieties of interdental brushes are available on the European market. 本指南適用於歐洲市場上可取得適當數量與種類的牙間刷之情況。
R4.7 | What is the value of dental flossing for interdental cleaning in periodontal maintenance patients? R4.7 | 對於牙周維護期患者而言,使用牙線進行牙間清潔的價值為何?
Evidence-based recommendation (4.7) 實證基礎建議 (4.7)
We do not suggest flossing as the first choice for interdental cleaning in periodontal maintenance patients. 我們不建議將牙線作為牙周維護期患者牙間清潔的首選方式。
Supporting literature Slot et al. (2020) 支持文獻 Slot 等人(2020)
Quality of evidence Six comparisons from four RCTs (162 patients) with unclear to high risk of bias 證據品質 來自四項隨機對照試驗(162 名患者)的六項比較,具有不明確至高度偏見風險
Grade of recommendation Grade B- darr\downarrow 推薦等級 B 級 darr\downarrow
Strength of consensus Consensus (5.6% of the group abstained due to potential Col) 共識強度 共識(5.6%的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
See previous sections. 請參閱前文。
Available evidence 現有證據
The underlying systematic review (Slot et al., 2020) found evidence for a significantly better cleaning effect of interdental brushes than of flossing. Both the descriptive analysis and the NMA indicate that IDBs are the first choice for periodontal maintenance patients. Six comparisons from four RCTs (162 patients) were identified. 基礎系統性回顧(Slot 等人,2020 年)發現證據顯示牙間刷的清潔效果明顯優於牙線。無論是描述性分析還是網絡統合分析都指出,牙間刷是牙周維護患者的首選工具。研究共識別出來自四項隨機對照試驗(162 名患者)的六組比較數據。
Risk of bias 偏誤風險
High to unclear. 證據等級為高至不明確。
Consistency 一致性
High. 高。
Clinical relevance and effect size 臨床相關性與效應量
Considered as clinically relevant. 視為具有臨床相關性。
Balance of benefit and harm 利益與風險的平衡
There is a moderate risk of trauma due to the use of interdental brushes or flossing, when not used properly. Therefore, individual instruction and adaptation to the individual situation by professionals are crucial. 若使用不當,牙間刷或牙線可能造成中度創傷風險。因此,專業人員的個別指導與根據個人情況調整至關重要。
Economic considerations 經濟效益考量
Not considered. 不予考慮。
Patient preferences 病患偏好
There is clinical evidence supporting that patients with open interdental spaces prefer the use of interdental brushes over the use of dental floss. 有臨床證據支持,對於牙縫較大的患者,使用牙間刷比使用牙線更受青睞。
Applicability 適用性
The guideline can be applied since appropriate quantities and varieties of interdental brushes are available on the European market. 由於歐洲市場上可取得適當數量與種類的牙間刷,本指南得以適用。
R4.8 What is the value of other interdental devices for interdental cleaning in periodontal maintenance patients? R4.8 對於牙周維護期患者而言,其他牙間清潔裝置的價值為何?
In interdental areas not reachable by toothbrushes, we suggest supplementing tooth brushing with the use of other interdental cleaning devices in periodontal maintenance patients. 對於牙刷無法觸及的牙間區域,我們建議牙周維護期患者可輔助使用其他牙間清潔裝置來補足刷牙的不足。
Supporting literature Slot et al. (2020) 支持文獻 Slot 等人 (2020)
Grade of recommendation Grade B- uarr\uparrow 推薦等級 B 級- uarr\uparrow
Strength of consensus Consensus (4.1% of the group abstained due to potential Col) 共識強度 共識 (4.1% 的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Other interdental cleaning devices include rubber/elastomeric cleaning sticks, wood sticks, an oral irrigator or dental floss. Although there are very small and fine interdental brushes available on the market, it must be realized that not all interdental spaces are readily accessible with interdental brushes. 其他牙間清潔工具包括橡膠/彈性清潔棒、木棒、口腔沖洗器或牙線。雖然市面上有非常細小的牙間刷,但必須意識到並非所有牙縫都能輕易使用牙間刷清潔。
Available evidence 現有證據
The underlying systematic review (Slot et al., 2020) identified three RCTs assessing the use of an adjunctive oral irrigator: two out of three studies demonstrated a significant effect of the irrigator on measures of gingival inflammation, but not on plaque scores. Rubber/elastomeric cleaning sticks are a relatively newly developed instruments with an increasing market share, and there only little evidence available on gingivitis patients that these devices are effective in reducing inflammation with no difference to interdental brushes (Abouassi et al., 2014; HennequinHoenderdos, van der Sluijs, van der Weijden, & Slot, 2018). 基礎系統性回顧(Slot 等人,2020 年)確定了三項評估輔助口腔沖洗器使用的隨機對照試驗:其中兩項研究顯示沖洗器對牙齦發炎指標有顯著效果,但對牙菌斑分數無影響。橡膠/彈性清潔棒是相對新開發的工具,市場佔有率逐漸增加,但目前僅有極少證據表明這些工具對牙齦炎患者能有效減少發炎,且與牙間刷相比無顯著差異(Abouassi 等人,2014 年;Hennequin-Hoenderdos、van der Sluijs、van der Weijden 與 Slot,2018 年)。
Risk of bias 偏差風險
High. 高。
Consistency 一致性
Not evaluated. 未評估。
Clinical relevance and effect size 臨床相關性與效應量
Considered as moderate. 視為中度。
Balance of benefit and harm 利益與風險的平衡
Up to now no adverse effects have been reported. 截至目前為止尚未有不良反應的報告。
Economic considerations 經濟效益考量
Not considered. 不予考慮。
Patient preferences 病患偏好
Rubber/elastomeric cleaning sticks are highly accepted by patients as are oral irrigators. 橡膠/彈性清潔棒與口腔沖洗器同樣受到患者高度接受。
Applicability 適用性
The guideline can be applied since appropriate quantities and varieties of interdental cleaning devices are available on the European market. 本指南可適用於歐洲市場上已有適當數量和種類的牙間清潔器具的情況。
R4.9 | What additional strategies in motivation are useful? R4.9 | 哪些額外的激勵策略是有用的?
We recommend utilizing the “First Step of Therapy” section of this guideline. 我們建議運用本指南中的「治療第一步驟」章節。
Supporting literature Carra et al. (2020) 支持文獻 Carra et al. (2020)
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Background information and the discussion of additional factors can be found in the section dealing with patients in active periodontal therapy (first step of therapy). 背景資訊與其他因素的討論,可參閱關於處於積極牙周治療階段患者(治療第一步驟)的章節。
R4.10 | What is the value of adjunctive antiseptics/ chemotherapeutic agents for the management of gingival inflammation? R4.10 | 輔助性抗菌劑/化學治療劑對於牙齦發炎管理的價值為何?
The basis of the management of gingival inflammation is selfperformed mechanical removal of biofilm. Adjunctive measures, including antiseptic, may be considered in specific cases, as part of a personalized treatment approach. 牙齦發炎管理的基礎是自我執行的機械性牙菌斑清除。在特定情況下,可考慮將抗菌劑等輔助措施納入個人化治療方案的一部分。
Supporting literature Figuero, Roldan, et al. (2019) 支持文獻 Figuero、Roldan 等人 (2019)
Grade of recommendation Grade 0-harr0-\leftrightarrow 推薦等級 等級 0-harr0-\leftrightarrow
Strength of consensus Consensus (11.8% of the group abstained due to potential Col) 共識強度 共識(11.8% 小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
In order to control gingival inflammation during periodontal maintenance, the adjunctive use of some agents has been proposed. These agents are mainly antiseptics agents, and can be delivered as dentifrices, as mouth rinses or both. 為了在牙周維護期間控制牙齦發炎,有人建議輔助使用某些藥劑。這些藥劑主要是抗菌劑,可以作為牙膏、漱口水或兩者兼用。
Available evidence 現有證據
A systematic review (Figuero, Roldan, et al., 2019) was conducted, aiming to identify RCTs of, at least, 6 months of follow-up, in treated periodontitis patients or in gingivitis patients, in which antiseptics, prebiotics, probiotics, anti-inflammatory agents and antioxidant micronutrients were used as adjuncts to mechanical supragingival biofilm control. For antiseptic agents, the impact in the primary outcome, changes in gingival indices (analysed in 52 studies with 72 comparisons, including 5,376 test and 3,693 control patients), was statistically significant ( p < .001p<.001 ) and the additional reduction, expressed as standardized weighted mean difference (S-WMD), was -1.3 (95% CI [-1.489; -1.047]), with significant heterogeneity ( p < .001p<.001 ). In treated periodontitis patients, analysed in 13 studies with 16 comparisons, including 1,125 test and 838 control patients, the impact was statistically significant ( p < .001p<.001 ) and the additional reduction, expressed as S-WMD, was -1.564 (95% CI [-2.197; -0.931]), with significant heterogeneity ( p < .001p<.001 ). No conclusions could be made for other, non-antiseptic, agents, since only one study was identified. Longerterm studies in treated periodontitis patients are also relevant to assess periodontal stability. In the systematic review (Figuero, Roldan, 一項系統性回顧研究(Figuero、Roldan 等人,2019 年)針對接受治療的牙周炎患者或牙齦炎患者進行,旨在找出至少 6 個月追蹤期的隨機對照試驗,這些試驗使用抗菌劑、益生元、益生菌、消炎藥及抗氧化微量營養素作為機械性齦上生物膜控制的輔助治療。就抗菌劑而言,其對主要結果(牙齦指數變化,共分析 52 項研究、72 組對照,包含 5,376 名測試組與 3,693 名對照組患者)的影響具有統計顯著性( p < .001p<.001 ),標準化加權平均差(S-WMD)顯示額外減少量為-1.3(95%信賴區間[-1.489; -1.047]),且存在顯著異質性( p < .001p<.001 )。在已接受治療的牙周炎患者中(共分析 13 項研究、16 組對照,包含 1,125 名測試組與 838 名對照組患者),其影響亦具統計顯著性( p < .001p<.001 ),S-WMD 顯示額外減少量為-1.564(95%信賴區間[-2.197; -0.931]),並存在顯著異質性( p < .001p<.001 )。由於僅識別出一項研究,故無法對其他非抗菌劑類輔助治療下結論。 治療牙周炎患者的長期研究對於評估牙周穩定性也相當重要。在系統性回顧中(Figuero, Roldan,
et al., 2019), four long-term studies (1.5-3 years) were identified, and no significant impact was observed for gingival indices. However, a 3-year study demonstrated significant benefits in terms of frequency of deep periodontal pockets and in the number of sites that exhibited additional attachment and bone loss (Rosling et al., 1997). 等人於 2019 年進行的研究中,共確認了四項長期研究(1.5-3 年),並未觀察到對牙齦指數有顯著影響。然而,一項為期 3 年的研究顯示,在深層牙周囊袋發生頻率及出現附加附連喪失與骨骼流失的部位數量方面具有顯著效益(Rosling 等人,1997 年)。
Risk of bias 偏誤風險
The great majority of these studies were industry-funded, and there was a high risk of bias both within and across studies. 絕大多數的研究都是由產業資助,且無論是單一研究或跨研究之間都存在高度的偏誤風險。
Consistency 一致性
Highly consistent across studies, 72 comparisons were included in the primary analysis. 各項研究高度一致,主要分析共納入 72 項比較。
Clinical relevance and effect size 臨床相關性與效應量
Considered as clinically relevant. 被視為具有臨床相關性。
Balance of benefit and harm 利益與風險的平衡
At least 31 studies assessed adverse events and PROMs and staining was the only relevant finding. 至少有 31 項研究評估了不良事件和患者報告結果指標,而牙齒染色是唯一具相關性的發現。
Economic considerations 經濟效益考量
The issue has not been addressed. For dentifrices, it may not be relevant, since a dentifrice has to be used combined with mechanical tooth brushing; for mouth rinse, the extra cost should be taken into consideration. It should also be noted that the evidence base contains studies using products that may no longer be available. 此問題尚未被解決。對於牙膏而言,可能不具相關性,因為牙膏必須配合機械性刷牙使用;至於漱口水,則需考量其額外成本。同時應注意的是,現有證據基礎中包含使用可能已停產產品的研究。
Patient preferences 病患偏好
Both dentifrices and mouth rinses are widely accepted by the population. 牙膏和漱口水都廣為大眾所接受。
Applicability 適用性
Demonstrated with studies testing large groups from the general population. The adjunctive use of some agents has been proposed in those subjects who are not able to effectively remove supragingival biofilms by the sole use of mechanical procedures, but there is no direct evidence to support this statement. 經由針對一般大眾群體的大規模研究證實。對於那些僅依靠機械性清潔程序無法有效清除齦上菌斑的患者,已有建議可輔助使用某些藥劑,但目前尚無直接證據支持此論點。
R4.11 | Should adjunctive chemotherapeutics be recommended for patients in supportive periodontal care? R4.11 | 是否應建議支持性牙周照護患者使用輔助化學治療藥物?
A. The use of adjunctive antiseptics may be considered in periodontitis patients in supportive periodontal care in helping to control gingival inflammation, in specific cases. A. 在特定情況下,可考慮對支持性牙周照護中的牙周炎患者使用輔助抗菌劑,以協助控制牙齦發炎。
B. We do not know whether other adjunctive agents (such as probiotics, prebiotics, anti-inflammatory agents, antioxidant micronutrients) are effective in controlling gingival inflammation in patients in supportive periodontal care. B. 我們尚不清楚其他輔助劑(如益生菌、益生元、消炎藥、抗氧化微量營養素)是否能有效控制支持性牙周照護患者的牙齦發炎。
Supporting literature Figuero, Roldan et al. (2019) 支持文獻 Figuero、Roldan 等人 (2019)
Quality of evidence 73 RCTs with, at least, 6-month follow-up 證據品質 73 項隨機對照試驗,至少追蹤 6 個月
A. Grade of recommendation Grade 0-harr0-\leftrightarrow A. 建議等級 Grade 0-harr0-\leftrightarrow
There is a need to define the term of use (e.g. 6 months?) 需要明確定義使用期限(例如 6 個月?)
Adverse effects should be taken into account. 應考量不良反應。
B. Grade of recommendation Grade 0-Statement: unclear, additional research needed B. 建議等級 等級 0-聲明:不明確,需進一步研究
Strength of consensus Consensus (6.9% of the group abstained due to potential Col) 共識強度 共識(6.9%的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
In order to control gingival inflammation during supportive periodontal care, the adjunctive use of some agents has been proposed. These agents are mainly antiseptics but some other agents, such as probiotics, prebiotics, anti-inflammatory agents and antioxidant micronutrients, can be found in the literature. These products are mainly delivered as dentifrices or mouth rinses. 為了在支持性牙周護理期間控制牙齦發炎,有人提出輔助使用某些藥劑。這些藥劑主要是抗菌劑,但文獻中也可找到其他藥劑,如益生菌、益生元、消炎藥和抗氧化微量營養素。這些產品主要以牙膏或漱口水的形式使用。
Available evidence 現有證據
See also previous section. The adjunctive use of antiseptic agents has been proposed in those subjects who are not able to effectively remove supragingival biofilms by the sole use of mechanical procedures. Actually, the recommendations of the XI European Workshop in Periodontology (2014) highlighted that (Chapple et al., 2015) “For the treatment of gingivitis and where improvements in plaque control are required, adjunctive use of anti-plaque chemical agents may be considered. In this scenario, mouth rinses may offer greater efficacy but require an additional action to the mechanical oral hygiene regime”. Recommending adjunctive antiseptics, to mechanical supragingival biofilm control, in a specific patient group, instead in the general population, is plausible, but there is no supporting evidence to defend it. Most studies assessing the adjunctive benefits of antiseptic formulations have been performed in general populations, with statistically significant benefits in plaque and gingival indices (Serrano, Escribano, Roldan, Martin, & Herrera, 2015). Therefore, different factors may be considered when deciding whether to recommend the use of an adjunctive agent to control gingival inflammation in patients in supportive periodontal care. It is noted that all patients need to use a toothbrush with a fluoride toothpaste. However, in those subjects who are not able to effectively control supragingival biofilms and/or gingival inflammation by the sole use of mechanical procedures, a decision is then made whether or not to utilise a toothpaste and/or a mouth rinse that contains a specific active agent (in addition to fluoride). This decision would follow a personalized approach to patient care and would need to consider two aspects: 另請參閱前文。對於無法僅透過機械性程序有效清除齦上生物膜的個案,建議輔助使用抗菌劑。事實上,第 11 屆歐洲牙周病學研討會(2014 年)的建議強調(Chapple 等人,2015 年):「針對牙齦炎治療及需要提升牙菌斑控制效果時,可考慮輔助使用抗牙菌斑化學製劑。在此情境下,漱口水可能提供更佳效果,但需在機械性口腔衛生措施外額外執行」。針對特定患者群體(而非一般人群)在機械性齦上生物膜控制外輔助使用抗菌劑雖具合理性,但目前尚無支持性證據佐證。多數評估抗菌製劑輔助效益的研究均在一般人群中進行,結果顯示對牙菌斑與牙齦指數具有統計學上的顯著改善(Serrano、Escribano、Roldan、Martin 與 Herrera,2015 年)。 因此,在決定是否建議使用輔助劑來控制支持性牙周照護患者的牙齦發炎時,可能需要考量不同因素。需注意的是,所有患者都需使用含氟牙膏的牙刷。然而,對於那些僅靠機械性清潔程序無法有效控制齦上生物膜和/或牙齦發炎的患者,則需進一步決定是否使用含有特定活性成分(除氟化物外)的牙膏和/或漱口水。此決策應遵循個人化照護原則,並需考量兩個面向:
Local factors consider levels of gingival inflammation related to plaque level, accessibility for cleaning, anatomical factors, etc. 局部因素需考量與牙菌斑程度相關的牙齦發炎狀況、清潔可及性、解剖學因素等。
General factors consider systemic factors, general health status, frailty, limited dexterity, etc., some of which may be more relevant in elderly patients. 全身性因素則需考量系統性因素、整體健康狀態、身體脆弱性、手部靈活度受限等,其中某些因素可能對老年患者更為重要。
The most frequent delivery format for antiseptic agents is dentifrices and mouth rinses, or even they can be delivered in both, simultaneously. The obvious benefit of dentifrice delivery is that no other delivery format is needed, and a dentifrice is going to be used anyway. Mouth rinse delivery offers a better distribution around the mouth (Serrano et al., 2015) and better pharmacokinetic properties (Cummins & Creeth, 1992). Some evidence suggests that the adjunctive use of mouth rinses may provide better outcomes than that of dentifrices. However, the evidence is conflictive and significant differences were only observed for the secondary outcome (Figuero, Roldan, et al., 2019). In addition, direct comparisons between similar agents/formulations, delivered either as dentifrice or mouth rinse, are not available. 抗菌劑最常見的給藥形式是牙膏和漱口水,甚至可同時採用兩種方式。牙膏給藥的明顯優點是不需其他給藥形式,且無論如何都會使用牙膏。漱口水給藥則能提供更佳的口腔分布(Serrano 等人,2015 年)與更優的藥物動力學特性(Cummins & Creeth,1992 年)。部分證據顯示,輔助使用漱口水可能比牙膏效果更好,但相關證據存在矛盾,且僅在次要結果觀察到顯著差異(Figuero、Roldan 等人,2019 年)。此外,目前尚無針對相同成分/配方分別以牙膏或漱口水形式給藥的直接比較研究。
The decision to select a specific toothpaste or a mouth rinse should be also based on a combination of factors: 選擇特定牙膏或漱口水時,應綜合考量多項因素:
Patient preferences including cost, taste, etc. 患者偏好包括費用、口感等因素
Unwanted effects including staining, burning sensation during use, etc. 不良反應包括使用時產生的染色、灼熱感等
Potential negative impacts on beneficial aspects of the oral microbiome highlighted in recent evidence (e.g. impact on nitric oxide pathway) (Bescos et al., 2020). 最新證據指出可能對口腔微生物群有益特性產生負面影響(例如對一氧化氮途徑的影響)(Bescos 等人,2020 年)
Potential negative impacts on blood pressure: one short-term (7days) study suggested a non-statistically significant “trend” for chlorhexidine mouth rinse to cause a small elevation in systolic blood pressure from 103 mmHg to 106 mHg (Bescos et al., 2020). The clinical significance of this is unknown. 可能對血壓造成負面影響:一項短期(7 天)研究顯示,氯己定漱口水可能導致收縮壓從 103 mmHg 微幅上升至 106 mmHg 的非統計顯著「趨勢」(Bescos 等人,2020 年)。其臨床意義尚不明確。
Depending on the specific agent already selected, a decision must be made regarding their frequency and duration of use. 根據已選定的特定成分,必須決定其使用頻率和持續時間。
R4.12 | Which antiseptic is the most effective in dentifrices? R4.12 | 哪種抗菌劑在牙膏中最有效?
Evidence-based recommendation (4.12) 實證建議 (4.12)
If an antiseptic dentifrice formulation is going to be adjunctively used, we suggest products containing chlorhexidine, triclosancopolymer and stannous fluoride-sodium hexametaphosphate for the control of gingival inflammation, in periodontitis patients in supportive periodontal care. 若考慮輔助使用抗菌牙膏配方,我們建議牙周炎患者在支持性牙周護理期間,可選用含氯己定、三氯生共聚物和氟化亞錫-六偏磷酸鈉的產品來控制牙齦發炎。
Supporting literature Escribano et al. (2016); Figuero, Herrera, et al. (2019); Figuero, Roldan, et al. (2019); Serrano et al. (2015) 支持文獻 Escribano 等人 (2016);Figuero、Herrera 等人 (2019);Figuero、Roldan 等人 (2019);Serrano 等人 (2015)
Quality of evidence Twenty-nine RCTs with, at least, 6-month follow-up 證據品質 29 項隨機對照試驗,至少進行 6 個月的追蹤
Grade of recommendation Grade B- uarr\uparrow 推薦等級 B 級 uarr\uparrow
Strength of consensus Consensus (17.4% of the group abstained due to potential Col) 共識強度 共識(17.4%的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
In order to control gingival inflammation during supportive periodontal care, the adjunctive use of some agents has been proposed. These products can be delivered as dentifrices. 為了在支持性牙周照護期間控制牙齦發炎,有人建議輔助使用某些藥劑。這些產品可以作為牙膏形式使用。
Available evidence 現有證據
In the systematic review (Figuero, Roldan, et al., 2019), the adjunctive use of 14 different dentifrice formulations was evaluated for controlling gingival inflammation, with a clear heterogeneity in the number of available studies for each product. The magnitude of effect in gingival indices changes, in formulations with more than one study available, was headed by stannous fluoride with sodium hexametaphosphate ( n=2n=2, S-WMD =-1.503=-1.503 ), followed by triclosan and copolymer ( n=18,S-WMD=-1.313n=18, \mathrm{~S}-\mathrm{WMD}=-1.313 ), and chlorhexidine ( n=2n=2, S-WMD =-1.278=-1.278, not statistically significant), although comparing the formulations was not a specific objective of the review. Effects on plaque levels were best with chlorhexidine at high concentrations ( n=3,S-WMD=-1.512n=3, \mathrm{~S}-\mathrm{WMD}=-1.512 ) and triclosan and copolymer ( n=23n=23, S-WMD = -1.164). In a previously published network meta-analyses, chlorhexidine and triclosan and copolymer were the most effective agents for plaque reduction, but no clear differences were observed for gingival index control (Escribano et al., 2016; Figuero, Herrera, et al., 2019). 在這項系統性回顧研究(Figuero、Roldan 等人,2019 年)中,評估了 14 種不同牙膏配方作為輔助治療控制牙齦發炎的效果,但每種產品可取得的研究數量存在明顯異質性。在擁有多項研究的配方中,對牙齦指數變化的影響程度以含六偏磷酸鈉的氟化亞錫( n=2n=2 ,S-WMD =-1.503=-1.503 )居首,其次為三氯沙與共聚物( n=18,S-WMD=-1.313n=18, \mathrm{~S}-\mathrm{WMD}=-1.313 )及氯己定( n=2n=2 ,S-WMD =-1.278=-1.278 ,統計上不顯著),儘管比較不同配方並非該回顧研究的特定目標。在牙菌斑控制方面,高濃度氯己定( n=3,S-WMD=-1.512n=3, \mathrm{~S}-\mathrm{WMD}=-1.512 )與三氯沙和共聚物( n=23n=23 ,S-WMD = -1.164)效果最佳。先前發表的網絡統合分析顯示,氯己定和三氯沙與共聚物是減少牙菌斑最有效的成分,但在控制牙齦指數方面未觀察到明顯差異(Escribano 等人,2016 年;Figuero、Herrera 等人,2019 年)。
Additional factors have been discussed in the overall evaluation of adjunctive agents. 在輔助治療劑的整體評估中,還討論了其他因素。
R4.13 | Which antiseptic is the most effective in mouth rinses? R4.13 | 哪種漱口水的抗菌劑最有效?
Evidence-based recommendation (4.13) 實證建議(4.13)
If an antiseptic mouth rinse formulation is going to be adjunctively used, we suggest products containing chlorhexidine, essential oils and cetylpyridinium chloride for the control of gingival inflammation, in periodontitis patients in supportive periodontal care. 若需輔助使用抗菌漱口水,我們建議在牙周炎患者的支持性牙周照護期間,選用含有氯己定、精油及氯化十六烷基吡啶的產品以控制牙齦發炎。
Supporting literature Escribano et al. (2016); Figuero, Herrera, et al. (2019); Figuero, Roldan, et al. (2019); Serrano et al. (2015) 支持文獻 Escribano 等人 (2016);Figuero、Herrera 等人 (2019);Figuero、Roldan 等人 (2019);Serrano 等人 (2015)
Quality of evidence CoE Class I-24 RCTs with, at least, 6-month follow-up 證據品質 證據等級 I 級 - 24 項隨機對照試驗,至少追蹤 6 個月
Grade of recommendation Grade B- uarr\uparrow 推薦等級 B 級 uarr\uparrow
Strength of consensus Consensus (17.9% of the group abstained due to potential Col) 共識強度 共識(17.9% 的小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
In order to control gingival inflammation during supportive periodontal care, the adjunctive use of some agents has been proposed. These products can be delivered as mouth rinses. 為了在牙周支持治療期間控制牙齦發炎,有人建議輔助使用某些藥劑。這些產品可以作為漱口水使用。
Available evidence 現有證據
In the systematic review (Figuero, Roldan, et al., 2019), the adjunctive use of 11 different mouth rinse formulations were evaluated for controlling gingival inflammation, with a clear heterogeneity in the number of available studies for each product. The magnitude of effect in gingival indices changes, in formulations with more than one study available, ranged from S-WMD = -2.248 (essential 在系統性回顧(Figuero、Roldan 等人,2019 年)中,評估了 11 種不同漱口配方作為輔助控制牙齦發炎的效果,但每種產品可獲取的研究數量存在明顯異質性。對於擁有多項研究的配方,其牙齦指數變化的效應量範圍從 S-WMD = -2.248(essential
oils, n=10n=10 ), to S-WMD = -1.499 (cetylpyridinium chloride, n=5n=5 ), and to S-WMD = -1.144 (chlorhexidine at high concentrations, n=5n=5 ), although comparing the formulations was not a specific objective of the review. In a previously published network metaanalyses (a statistical technique which allows the integration of data from direct and indirect comparisons, namely treatments compared among trials through a common comparator treatment), chlorhexidine and essential oil mouth rinses were ranked as the most efficacious agents in terms of changes in plaque and gingival indices (Escribano et al., 2016; Figuero, Herrera, et al., 2019). 油類漱口水( n=10n=10 )的標準化加權平均差(S-WMD)為-1.499(西吡氯銨, n=5n=5 ),以及高濃度氯己定( n=5n=5 )的 S-WMD 為-1.144,儘管比較不同配方並非本回顧研究的特定目標。在先前的網絡統合分析(一種統計技術,可整合直接與間接比較數據,即透過共同對照治療進行跨試驗比較)中,氯己定與精油漱口水在牙菌斑指數和牙齦指數變化方面被列為最有效的製劑(Escribano 等人,2016 年;Figuero、Herrera 等人,2019 年)。
Additional factors have been discussed in the overall evaluation of adjunctive agents. 在輔助藥劑的整體評估中,已討論了其他因素。
R4.14 | What is the value of professional mechanical plaque removal (PMPR) as part of SPC? R4.14 | 專業機械性牙菌斑清除(PMPR)作為支持性牙周照護(SPC)的一部分,其價值為何?
Expert consensus-based recommendation (4.14) 專家共識建議(4.14)
We suggest performing routine professional mechanical plaque removal (PMPR) to limit the rate of tooth loss and provide periodontal stability/improvement, as part of a supportive periodontal care program. 我們建議在支持性牙周照護計畫中,定期執行專業機械性牙菌斑清除(PMPR),以降低牙齒喪失率並維持/改善牙周穩定性。
Supporting literature Trombelli et al. (2015) 參考文獻 Trombelli et al. (2015)
Grade of recommendation Grade B- uarr\uparrow 推薦等級 B- 級 uarr\uparrow
Strength of consensus Strong consensus (1.4% of the group abstained due to potential Col) 共識強度 強烈共識(1.4% 小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
Professional mechanical plaque removal (PMPR) administered on a routine basis (i.e. at specific, predetermined intervals) as an integral part of supportive periodontal care has been shown to result in low rates of tooth loss and limited attachment level changes in both the short- and long-term in patients treated for periodontitis (Heasman, McCracken, & Steen, 2002; Trombelli et al., 2015). In most of the studies, PMPR in SPC was often combined with other procedures (e.g. reinforcement of oral hygiene instruction, additional active treatment at sites showing disease recurrence), thus making it difficult to isolate information on the magnitude of the mere effect of PMPR on tooth survival and stability of periodontal parameters (Trombelli et al., 2015). 作為支持性牙周照護的重要組成部分,定期(即在特定預定間隔)實施的專業機械性牙菌斑清除(PMPR)已被證實能為接受牙周炎治療的患者帶來較低的牙齒喪失率和短期/長期附連水平變化(Heasman, McCracken, & Steen, 2002; Trombelli et al., 2015)。在多數研究中,支持性照護期間的 PMPR 常與其他程序結合實施(例如加強口腔衛生指導、對疾病復發部位進行額外積極治療),因此難以單獨評估 PMPR 對牙齒存活率及牙周參數穩定性的純粹影響程度(Trombelli et al., 2015)。
Available evidence 現有證據
This issue has not been directly addressed in the systematic reviews prepared for this Workshop; however, ample evidence is 此議題未在本工作坊準備的系統性文獻回顧中直接探討;然而現有充分證據顯示
available to support this statement. It has been demonstrated that professional mechanical plaque removal (PMPR), performed at defined intervals, together with the other interventions of supportive periodontal care may result in lower rates of tooth loss and attachment level changes. In a systematic review (Trombelli et al., 2015), presented at the 2014 European Workshop, a weighted mean yearly rate of tooth loss of 0.15 and 0.09 for follow-up of 5 years or 12-14 years, respectively, was reported; the correspondent figures for mean clinical attachment loss lower than 1 mm at fol-low-up ranging from 5 to 12 years. Information from this review, and also from other systematic reviews, collectively supports that patients with a history of treated periodontitis can maintain their dentition with limited variations in periodontal parameters when regularly complying with a SPC regimen based on routine PMPR (Sanz et al., 2015). 目前尚無足夠證據支持此項聲論。已有研究證實,定期執行專業機械性牙菌斑清除術(PMPR)並配合其他牙周支持性治療措施,可降低牙齒喪失率與附連組織變化程度。根據 2014 年歐洲研討會發表之系統性文獻回顧(Trombelli 等人,2015 年)顯示,在 5 年追蹤期與 12-14 年追蹤期分別呈現加權平均每年 0.15 顆與 0.09 顆的牙齒喪失率;而臨床附連組織喪失量平均值在 5 至 12 年追蹤期間均維持小於 1 毫米。該文獻回顧及其他相關系統性研究共同證實,曾接受牙周炎治療的患者若能定期遵循以常規 PMPR 為基礎的牙周支持性照護方案,其牙列狀態與牙周參數皆能維持在有限變動範圍內(Sanz 等人,2015 年)。
Risk of bias 偏誤風險
The methodological quality was assessed with a specifically designed scale for the evaluation of non-randomized observational studies, with a quality level ranging from 3 to 7, in a 9-point scale, with 9 representing the highest quality (lowest risk of bias). 方法學品質是使用專門設計的量表來評估非隨機觀察性研究,品質等級範圍從 3 到 7 分(滿分 9 分),9 分代表最高品質(偏差風險最低)。
Consistency 一致性
Although no meta-analysis was possible, the primary outcome (tooth loss) was reported in 12 studies, showing no or low incidence. Clinical attachment level (CAL) changes were reported in 10 studies, which consistently showed limited modifications in CAL, frequently as a slight CAL loss. 雖然無法進行統合分析,但有 12 項研究報告了主要結果(牙齒喪失),顯示無或低發生率。臨床附著水平(CAL)變化在 10 項研究中被報告,這些研究一致顯示 CAL 的改變有限,通常為輕微的 CAL 喪失。
Clinical relevance and effect size 臨床相關性與效應量
A weighted mean yearly rate of tooth loss of 0.15 for follow-up of 5 years, and 0.09 for follow-up of 12-14 years, can be considered as relevant. 加權平均每年牙齒喪失率在 5 年追蹤期為 0.15,在 12-14 年追蹤期為 0.09,可被視為具有參考價值。
Balance of benefit and harm 利益與風險的平衡
PROMs were not reported in the included studies. 納入研究中未報告患者報告結果指標(PROMs)。
Economic considerations 經濟效益考量
Ethics and legal aspects are not relevant for this intervention; economic aspects have not been frequently addressed. In a study in a private practice in Norway, it was demonstrated that regular maintenance was associated with less tooth loos than not regular maintenance, with follow-ups of 16-26 years; the yearly cost of maintaining a tooth was estimated in 20.2 euro (Fardal & Grytten, 2014). 倫理與法律層面對此介入措施不具相關性;經濟層面則較少被探討。挪威一項私人診所的研究顯示,定期維護與較低的牙齒喪失率相關(追蹤期 16-26 年),每顆牙齒的年度維護成本估計為 20.2 歐元(Fardal & Grytten, 2014)。
Patient preferences 病患偏好
Demonstrated with compliance in long-term studies. 在長期研究中展現出合規性。
Applicability 適用性
Demonstrated with studies testing large groups from the general population. 經由針對一般大規模群體進行的研究證實。
R4.15 | Should alternative methods be used for professional mechanical plaque removal (PMPR) in supportive periodontal care? R4.15 | 在支持性牙周照護中,是否應採用替代方法進行專業機械性牙菌斑清除(PMPR)?
Evidence-based recommendation (4.15) 實證基礎建議(4.15)
We suggest not to replace conventional professional mechanical plaque removal (PMPR) with the use of alternative methods (Er:YAG laser treatment) in supportive periodontal care. 我們建議在支持性牙周照護中,不應以替代方法(鉺雅鉻雷射治療)取代傳統的專業機械性牙菌斑清除(PMPR)。
Supporting literature Trombelli et al. (2020) 支持文獻 Trombelli 等人 (2020)
Quality of evidence One RCT 證據品質 一項隨機對照試驗
Grade of recommendation Grade B- darr\downarrow 推薦等級 B 級 darr\downarrow
Strength of consensus Strong consensus (1.4% of the group abstained due to potential Col) 共識強度 強烈共識 (1.4%的小組成員因潛在利益衝突棄權)
Background 背景
Intervention 介入措施
The systematic review (Trombelli et al., 2015) was retrieving available RCTs on any given alternative intervention to conventional PMPR (the latter including supragingival and/or subgingival removal of plaque, calculus and debris performed with manual and/or powered instruments) in the maintenance of periodontitis patients with a follow-up of at least 1 year following the first administration of intervention/control treatment. 系統性文獻回顧(Trombelli 等人,2015 年)旨在檢索關於任何替代傳統 PMPR(後者包括使用手動和/或動力器械進行齦上及/或齦下菌斑、牙結石與碎屑清除)之介入方式的隨機對照試驗,這些研究針對牙周炎患者進行至少 1 年追蹤,自首次實施介入/對照治療後開始計算。
Available evidence 現有證據
In the systematic review (Trombelli et al., 2020), only one RCT was identified, assessing Er:YAG laser as an alternative method to conventional PMPR. No statistically significant differences were found (Krohn-Dale, Boe, Enersen, & Leknes, 2012). 在系統性文獻回顧(Trombelli 等人,2020 年)中,僅發現一項評估 Er:YAG 雷射作為傳統 PMPR 替代方法的隨機對照試驗。研究結果未顯示統計學上的顯著差異(Krohn-Dale, Boe, Enersen, & Leknes, 2012)。
Economic considerations 經濟效益考量
Cost-benefit or cost-effective analyses are missing and may be very relevant when considering this specific treatment option. The same is true for PROMs. 成本效益或成本效益分析目前尚缺,在考慮此特定治療選項時可能非常相關。對於患者報告結果指標(PROMs)亦是如此。
R4.16 | Should adjunctive methods be used for professional mechanical plaque removal (PMPR) in supportive periodontal care? R4.16 | 在支持性牙周照護中,是否應使用輔助方法進行專業機械性牙菌斑清除(PMPR)?
Evidence-based recommendation (4.16) 實證基礎建議(4.16)
We suggest not to use adjunctive methods (sub-antimicrobial dose doxycycline, photodynamic therapy) to professional mechanical plaque removal (PMPR) in supportive periodontal care. 我們建議在支持性牙周照護中,不要使用輔助方法(次抗菌劑量多西環素、光動力療法)來進行專業機械性牙菌斑清除(PMPR)。
Supporting literature Trombelli et al. (2020) 參考文獻 Trombelli et al. (2020)
Quality of evidence Two RCTs 證據品質 兩項隨機對照試驗
Grade of recommendation Grade B- darr\downarrow 推薦等級 B 級 darr\downarrow
Strength of consensus Strong consensus (2.7% of the group abstained due to potential Col) 共識強度 強烈共識(2.7%的成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
The systematic review (Trombelli et al., 2015) was retrieving available RCTs on any given additional intervention to conventional PMPR (the latter including supragingival and/or subgingival removal of plaque, calculus and debris performed with manual and/or powered instruments) in the maintenance of periodontitis patients with a follow-up of at least 1 year following the first administration of intervention/control treatment. 該系統性回顧(Trombelli 等人,2015 年)旨在檢索關於任何在傳統牙周機械性根面清潔(包括使用手動和/或動力器械進行齦上及/或齦下菌斑、牙結石和碎屑清除)基礎上附加介入措施,對牙周炎患者進行至少一年追蹤治療的隨機對照試驗。
Available evidence 現有證據
In the systematic review (Trombelli et al., 2020), two RCTs were identified, one testing sub-antimicrobial dose ( 20 mg b.i.d.) of doxycycline (Reinhardt et al., 2007), another evaluating photodynamic therapy (PDT) with a 0.01%0.01 \% methylene blue as photosensitizer and a diode laser (wavelength of 660 nm ) (Carvalho et al., 2015). No statistically significant differences were observed in any study, although CAL gain was more relevant with adjunctive PDT ( 1.54 mm ) in comparison with conventional PMPR alone ( 0.96 mm ). The systematic review presented at this Workshop provided information, based on meta-analysis, of the possible effects of the alternative/adjunctive methods mentioned, with no significant difference for the primary outcome (CAL changes), after 12-month follow-up, amounting -0.233 mm (95% CI [-1.065; 0.598; p=.351p=.351 ), favouring the control groups. 在系統性回顧(Trombelli 等人,2020 年)中,確定了兩項隨機對照試驗,一項測試了次抗菌劑量(20 毫克,每日兩次)的多西環素(Reinhardt 等人,2007 年),另一項評估了使用 0.01%0.01 \% 亞甲藍作為光敏劑和二極體激光(波長 660 奈米)的光動力療法(PDT)(Carvalho 等人,2015 年)。雖然與傳統的 PMPR 單獨治療(0.96 毫米)相比,輔助性 PDT 治療的 CAL 增益(1.54 毫米)更為顯著,但在任何研究中均未觀察到統計學上的顯著差異。本次研討會上提出的系統性回顧基於 Meta 分析提供了上述替代/輔助方法可能效果的資訊,在 12 個月的隨訪後,主要結果(CAL 變化)無顯著差異,總計為-0.233 毫米(95% CI [-1.065; 0.598; p=.351p=.351 ),傾向於對照組。
Economic considerations 經濟效益考量
For the adjunctive use of SDD, adverse effects and cost-benefit ratio have to be considered. For the adjunctive use of PDT, a previous systematic review (Xue et al., 2017), which included 11 RCTs, found better results for PDT, but only after 3 months, with 0.13 mm of additional impact in PPD reduction. No increase in adverse events were reported. Cost-benefit or cost-effective analyses are missing and may be very relevant when considering this specific treatment option. 關於輔助使用 SDD(亞抗菌劑量多西環素),必須考量其副作用與成本效益比。至於輔助使用 PDT(光動力治療),先前一份涵蓋 11 項隨機對照試驗的系統性文獻回顧(Xue 等人,2017 年)發現,PDT 僅在治療 3 個月後才顯現較佳效果,對牙周探測深度(PPD)減少量僅增加 0.13 毫米的影響。研究報告中未提及不良事件增加的情況,但缺乏成本效益或成本效果分析,這在評估此特定治療選項時可能相當重要。
8.5 | Intervention: Risk factor control 8.5 | 介入措施:風險因子控制
R4.17 | What is the value of risk factor control in SPC? R4.17 | 風險因子控制在支持性牙周照護(SPC)中的價值為何?
We recommend risk factor control interventions in periodontitis patients in supportive periodontal care. 我們建議對牙周炎患者進行支持性牙周照護時,應實施風險因子控制措施。
Supporting literature Ramseier et al. (2020) 參考文獻 Ramseier et al. (2020)
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 建議等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Periodontitis patients benefit from additional risk factor control interventions to improve the maintenance of periodontal stability. Interventions include patient education which be staged and adapted according to individual needs ranging from single brief advice to patient referral for advanced counselling and pharmacotherapy. Smoking and diabetes are two of the main risk factors for periodontitis, and they are currently included in the grading of periodontitis (Papapanou et al., 2018). Controlling these risk factors therefore would be critical for treatment response and for long-term stability. In addition, other relevant factors, part a healthy life-style counselling, are considered, including dietary counselling, physical exercise or weight loss. These interventions, together with those for tobacco cessation and diabetes control, are not direct responsibility of oral health professionals, and they may want to refer the patients to other health professionals. However, the direct/indirect role of oral health professionals in these interventions should be emphasized. 牙周炎患者可透過額外的風險因子控制介入措施來提升牙周穩定性維持。這些介入措施包含分階段且依個人需求調整的病患衛教,從簡短建議到轉介進行進階諮詢與藥物治療皆涵蓋在內。吸菸與糖尿病是牙周炎兩大主要風險因子,目前已被納入牙周炎分級系統(Papapanou 等人,2018 年)。因此控制這些風險因子對於治療反應與長期穩定性至關重要。此外,作為健康生活型態諮詢的一部分,其他相關因素如飲食指導、體能鍛鍊或體重管理也應納入考量。這些介入措施連同戒菸與糖尿病控制,雖非口腔健康專業人員的直接職責範圍,但可考慮將患者轉介給其他醫療專業人員。然而,必須強調口腔健康專業人員在這些介入措施中所扮演的直接/間接角色。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), the authors have identified 13 relevant guidelines for interventions for smoking cessation, diabetes control, physical exercise (activity), change of diet, carbohydrate (dietary sugar reduction) and weight loss. In addition, 25 clinical studies were found that assess the impact of (some of) these interventions in gingivitis/periodontitis patients. However, only some of them included patients in supportive periodontal care. 在系統性文獻回顧(Ramseier 等人,2020 年)中,作者們已識別出 13 項與戒菸、糖尿病控制、體能運動(活動)、飲食改變、碳水化合物(減少飲食糖分攝取)及減重相關的介入措施指南。此外,還發現 25 項臨床研究評估這些介入措施(部分)對牙齦炎/牙周炎患者的影響。然而,其中僅有部分研究納入了接受牙周支持性治療的患者。
Additional factors have been discussed in the evaluation of risk factor control in patients in active periodontal therapy. 在評估活躍期牙周治療患者的風險因子控制時,已討論了其他附加因素。
R4.18 | What is the role of tobacco smoking cessation interventions in SPC? R4.18 | 戒菸介入措施在牙周支持性治療中扮演何種角色?
Evidence-based recommendation (4.18) 實證建議 (4.18)
We recommend tobacco smoking cessation interventions to be implemented in periodontitis patients in supportive periodontal care. 我們建議在牙周炎患者的支持性牙周照護中實施戒菸介入措施。
Supporting literature Ramseier et al. (2020) 參考文獻 Ramseier et al. (2020)
Quality of evidence Six prospective studies with, at least, 6-month follow-up 證據品質 六項前瞻性研究,至少追蹤六個月
Grade of recommendation Grade A-uarr uarr\mathrm{A}-\uparrow \uparrow 建議等級 等級 A-uarr uarr\mathrm{A}-\uparrow \uparrow
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%小組成員因潛在利益衝突而棄權)
Background 背景
Background information and the discussion of additional factors can be found in the section dealing with patients in active periodontal therapy. 背景資訊和其他因素的討論可以在關於進行積極牙周治療患者的章節中找到。
R4.19 | What is the role of promotion of diabetes control interventions in SPC? R4.19 | 在牙周支持性照護(SPC)中,促進糖尿病控制介入措施扮演什麼角色?
Expert consensus-based recommendation (4.19) 專家共識建議(4.19)We suggest promotion of diabetes control interventions in patients in maintenance therapy. 我們建議在進行維持治療的患者中推廣糖尿病控制介入措施。Supporting literature Ramseier et al. (2020) 參考文獻 Ramseier et al. (2020)Grade of recommendation Grade B- uarr\uparrow 推薦等級 B 級 uarr\uparrowStrength of consensus Consensus (0% of the group abstained due to potential Col) 共識強度 共識(0%的組員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Periodontitis patients may benefit from the promotion of diabetes control interventions to improve the maintenance of periodontal stability. The promotion may consist of patient education including brief dietary counselling and possibly patient referral for glycaemic control. 牙周炎患者可能受益於促進糖尿病控制措施,以改善牙周穩定的維持。促進措施可包括患者教育,其中包含簡短的飲食諮詢,並可能轉介患者進行血糖控制。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), none of the identified studies was performed in patients in supportive periodontal care. Indirect evidence (see section on active periodontal therapy) suggests that diabetes control interventions ought to be implemented in supportive periodontal care patients. 在系統性文獻回顧(Ramseier 等人,2020 年)中,所確定的研究均未在牙周支持性治療患者中進行。間接證據(參見活躍期牙周治療章節)表明,糖尿病控制措施應實施於接受牙周支持性治療的患者。
Background information and the discussion of additional factors can be found in the section dealing with patients in active periodontal therapy. 背景資訊及其他影響因素的討論,可參閱活躍期牙周治療患者相關章節。
R4.20 | What is the role of physical exercise (activity), dietary counselling or lifestyle modifications aiming at weight loss in SPC? R4.20 | 在支持性牙周照護中,體能鍛鍊(活動)、飲食諮詢或旨在減重的生活方式調整扮演什麼角色?
We do not know whether physical exercise (activity), dietary counselling or lifestyle modifications aiming at weight loss are relevant in supportive periodontal care. 我們尚不清楚體能鍛鍊(活動)、飲食諮詢或旨在減重的生活方式調整是否與支持性牙周照護相關。
Supporting literature Ramseier et al. (2020) 參考文獻 Ramseier et al. (2020)
Grade of recommendation Grade 0-Statement: unclear, additional research needed 推薦等級 0 級-聲明:尚不明確,需要進一步研究
Strength of consensus Strong consensus (0% of the group abstained due to potential Col) 共識強度 強烈共識(0%的組員因潛在利益衝突而棄權)
Background 背景
Intervention 介入措施
Overall evidence from the medical literature suggests that the promotion of physical exercise (activity) interventions may improve both treatment and long-term management of non-communicable diseases. In periodontitis patients, the promotion may consist of 醫學文獻的整體證據顯示,推廣運動(活動)介入措施可能有助於改善非傳染性疾病的治療與長期管理。對於牙周炎患者,此推廣可包含
patient education specifically target to the patients’ age and general health. 針對患者年齡與整體健康狀況量身打造的衛教內容。
Available evidence 現有證據
In the systematic review (Ramseier et al., 2020), none of the identified studies was performed in patients in supportive periodontal care. 系統性文獻回顧(Ramseier 等人,2020 年)指出,目前並無任何研究是在牙周支持性治療患者中進行。
Background information and the discussion of additional factors can be found in the section dealing with patients in active periodontal therapy (Billings et al., 2018). 相關背景資訊與其他影響因素的討論,可參閱牙周活性治療患者專章(Billings 等人,2018 年)。
ACKNOWLEDGEMENTS 致謝
The authors express their gratitude to all reviewers involved in the preparation of the systematic reviews. In addition, the organizations which accepted to participate in the guideline development process are also kindly and sincerely acknowledged: European Federation of Conservative Dentistry, European Association of Dental Public Health, European Society for Endodontology, European Prosthodontic Association, Council of European Dentists, European Dental Hygienists’ Federation, European Dental Students’ Association and Platform for Better Oral Health in Europe. 作者們對所有參與系統性文獻回顧審查的專家學者表達誠摯謝意。同時,我們也要衷心感謝以下參與本臨床指引制定過程的專業組織:歐洲保守牙醫聯合會、歐洲口腔公共衛生協會、歐洲牙髓病學會、歐洲義齒修復協會、歐洲牙醫理事會、歐洲牙科衛生師聯合會、歐洲牙醫學生協會,以及歐洲口腔健康促進平台。
CONFLICT OF INTEREST 利益衝突聲明
Workshop participants filed detailed disclosure of potential conflict of interest relevant to the workshop topics, and these are kept on file. Declared potential dual commitments included having received research funding, consultant fees and speaker fee from the industries with economic interests in the interventions for prevention and therapy of Periodontitis. Those affected with potential conflict of interest abstained from vote in the specific recommendations following the required processes for S3 level clinical practice guideline. Individual potential conflict of interest forms were completed by all participants and are available on file at the European Federation of Periodontology and extracted in the Supporting Information, available online (Final GuidelineSupporting Information_Potential conflict of interests). In addition, potential conflict of interest information of the chairs of the workshop is listed here. 工作坊參與者已詳細申報與工作坊主題相關的潛在利益衝突,並存檔備查。申報的潛在雙重承諾包括曾接受與牙周炎預防及治療介入措施具經濟利益關係之產業提供的研究經費、顧問費及演講費。根據 S3 級臨床實踐指南要求程序,涉及潛在利益衝突者於特定建議表決時迴避投票。所有參與者均填寫個人潛在利益衝突申報表,檔案存放於歐洲牙周病學聯合會,並摘錄於線上公開之附錄資料(最終指南附錄_潛在利益衝突)。此外,工作坊主席之潛在利益衝突資訊列示如下。
Dr. Mariano Sanz (Chair) reports personal fees from Camlog implants, Colgate, Dentium Implants, Dentsply Sirona Implants, Geistlich, GSK, Klockner Implants, MIS Implants, Mozo Grau Implants, Nobel Biocare, Procter & Gamble, Straumann and Sunstar; grants from Camlog Implants, Dentaid, Dentium Implants, Dentsply Sirona Implants, Geistlich Pharma, Klockner Implants, MIS Implants, Mozo Grau Implants, Nobel Biocare, Sunstar, Straumann AG, Sweden and Martina Implants; and other support from Dentaid, outside the submitted work. Mariano Sanz 博士(主席)聲明在提交工作之外,曾接受以下機構的個人酬金:Camlog 植體、高露潔、Dentium 植體、登士柏西諾德植體、Geistlich、葛蘭素史克、Klockner 植體、MIS 植體、Mozo Grau 植體、諾保科、寶僑家品、士卓曼及 Sunstar;並獲得以下機構的資助:Camlog 植體、Dentaid、Dentium 植體、登士柏西諾德植體、Geistlich 製藥、Klockner 植體、MIS 植體、Mozo Grau 植體、諾保科、Sunstar、士卓曼股份公司、瑞典及 Martina 植體;以及來自 Dentaid 的其他支援。
Dr. David Herrera (Chair) reports personal fees from Colgate, Dentaid, Dexcel Pharma, GSK, Johnson & Johnson, Klockner Implants, Procter & Gamble and Straumann and grants from Colgate, Dentaid, GSK, Kulzer and Zimmer-Biomet, outside the submitted work. David Herrera 博士(主席)聲明在提交工作之外,曾接受以下機構的個人酬金:高露潔、Dentaid、Dexcel 製藥、葛蘭素史克、嬌生、Klockner 植體、寶僑家品及士卓曼;並獲得以下機構的資助:高露潔、Dentaid、葛蘭素史克、Kulzer 及捷邁邦美。
Dr. Moritz Kebschull (Chair) reports personal fees from Colgate, Dexcel Pharma, Geistlich Pharma, Hu-Friedy, NSK and Procter & Moritz Kebschull 博士(主席)報告了來自高露潔、Dexcel 製藥、Geistlich 製藥、Hu-Friedy、NSK 以及寶僑的個人費用
Gamble and non-financial support from Colgate, Dexcel Pharma, Geistlich Pharma, Hu-Friedy, NSK and Procter & Gamble, outside the submitted work. 高露潔、Dexcel 製藥、Geistlich 製藥、Hu-Friedy、NSK 以及寶僑公司提供的賭博與非財務支持,與本提交工作無關。
Dr. Iain Chapple (Chair) reports personal fees from Procter & Gamble and grants from GSK and Unilever, outside the submitted work. In addition, Dr. Chapple has eight patents on saliva diagnostics issued and his wife runs Oral Health Innovations that has the license for PreViser and DEPPA risk assessment software in the UK. Iain Chapple 博士(主席)報告指出,在提交工作之外,他從寶僑公司獲得個人報酬,並從葛蘭素史克與聯合利華獲得資助。此外,Chapple 博士擁有八項唾液診斷專利,其配偶經營的 Oral Health Innovations 公司在英國擁有 PreViser 與 DEPPA 風險評估軟體的授權。
Dr. Sören Jepsen (Chair) reports personal fees from Colgate, Geistlich Pharma and Procter & Gamble, outside the submitted work. Sören Jepsen 博士(主席)報告指出,在提交工作之外,他從高露潔、Geistlich 製藥以及寶僑公司獲得個人報酬。
Dr. Tord Berglundh (Chair) reports personal fees from Dentsply Sirona Implants and Straumann and grants from Dentsply Sirona Implants, outside the submitted work. Tord Berglundh 博士(主席)報告指出,在提交工作之外,他從登士柏西諾德植體與士卓曼獲得個人報酬,並從登士柏西諾德植體獲得資助。
Dr. Anton Sculean (Chair) reports personal fees from Botiss Biomaterials, Geistlich Pharma, Oral Reconstruction Foundation, Osteology Foundation, Straumann AG, Regedent AG and Stoma and grants from Botiss Biomaterials, Geistlich Pharma, ITI Foundation, Oral Reconstruction Foundation, Osteology Foundation, Straumann AG and Regedent AG, outside the submitted work. Anton Sculean 博士(主席)聲明在本研究之外,曾接受 Botiss Biomaterials、Geistlich Pharma、Oral Reconstruction Foundation、Osteology Foundation、Straumann AG、Regedent AG 及 Stoma 的個人酬金,並獲得 Botiss Biomaterials、Geistlich Pharma、ITI Foundation、Oral Reconstruction Foundation、Osteology Foundation、Straumann AG 及 Regedent AG 的研究資助。
Dr. Maurizio Tonetti (Chair) reports personal fees from Geistlich Pharma AG, Procter & Gamble, Straumann AG, Sunstar SA anf Unilever; grants from Geistlich Pharma and Sunstar SA; and non-financial support from Procter & Gamble, outside the submitted work. Maurizio Tonetti 博士(主席)申報在本研究之外,曾接受 Geistlich Pharma AG、寶僑公司(Procter & Gamble)、士卓曼集團(Straumann AG)、Sunstar SA 及聯合利華(Unilever)的個人酬金;獲得 Geistlich Pharma 與 Sunstar SA 的研究資助;並接受寶僑公司提供的非財務支援。
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International Committee of Medical Editors. ICMJE Form for disclosure of potential conflicts of interest. Retrieved from http://www.icmje.org/ conflicts-of-interest/ 國際醫學期刊編輯委員會。ICMJE 利益衝突揭露表單。取自 http://www.icmje.org/conflicts-of-interest/
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How to cite this article: Sanz M, Herrera D, Kebschull M, et al; On behalf of the EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020;47:4-60. https://doi.org/10.1111/jcpe. 13290 引用本文方式:Sanz M、Herrera D、Kebschull M 等人;代表 EFP 研討會參與者及方法學顧問。《第一至三期牙周炎治療—EFP S3 級臨床實踐指南》。《臨床牙周病學期刊》。2020;47:4-60。https://doi.org/10.1111/jcpe.13290
APPENDIX 1 附錄 1
WORKSHOP PARTICIPANTS 研討會參與者
Anne Merete Aass, Mario Aimetti, Georgios Belibasakis, Juan Blanco, Ellen Bol-van den Hil, Nagihan Bostanci, Darko Bozic, Philippe Bouchard, Nurcan Buduneli, Francesco Cairo, Elena Calciolari, Maria Clotilde Carra, Pierpaolo Cortellini, Jan Cosyn, Francesco D’Aiuto, Bettina Dannewitz, Monique Danser, Korkud Demirel, Jan Derks, Massimo de Sanctis, Thomas Dietrich, Christof Dörfer, Henrik Dommisch, Nikos Donos, Kenneth Eaton, Peter Eickholz, Elena Figuero, William Giannobile, Moshe Goldstein, Filippo Graziani, Phophi Kamposiora, Lise-Lotte Kirkevang, Thomas Kocher, Eija Kononen, Bahar Eren Kuru, France Lambert, Luca Landi, Nicklaus Lang, Bruno Loos, Rodrigo Lopez, Pernilla Lundberg, Eli Machtei, Phoebus Madianos, Conchita Martín, Paula Matesanz, Paulo Melo, Jörg Meyle, Ana Molina, Eduardo Montero, Jose Nart, Ian Needleman, Luigi Nibali, Panos Papapanou, Andrea Pilloni, David Polak, loannis Polyzois, Philip Preshaw, Marc Quirynen, Christoph Ramseier, Stefan Renvert, Giovanni Salvi, Ignacio Sanz-Sánchez, Lior Shapira, Dagmar Else Slot, Andreas Stavropoulos, Xavier Struillou, Jean Suvan, Wim Teughels, Daniela Timus, Cristiano Tomasi, Leonardo Trombelli, Fridus van der Weijden, Paula Vassallo, Clemens Walter, Nicola West, Gernot Wimmer 安妮·梅瑞特·阿阿斯、馬里奧·艾梅蒂、喬治奧斯·貝利巴斯克斯、胡安·布蘭科、艾倫·波爾-范登希爾、娜吉漢·博斯坦奇、達爾科·博日奇、菲利普·布沙爾、努爾坎·布杜內利、弗朗切斯科·開羅、埃琳娜·卡爾喬拉里、瑪麗亞·克洛蒂爾德·卡拉、皮爾保羅·科爾特利尼、揚·科辛、弗朗切斯科·達伊烏托、貝蒂娜·丹內維茨、莫妮克·丹瑟、科爾庫德·德米雷爾、揚·德克斯、馬西莫·德桑克蒂斯、托馬斯·迪特里希、克里斯托夫·德費爾、亨里克·多米施、尼科斯·多諾斯、肯尼斯·伊頓、彼得·艾克霍爾茲、埃琳娜·菲格羅、威廉·詹諾比爾、摩西·戈爾茨坦、菲利波·格拉齊亞尼、福菲·坎波西奧拉、莉絲-洛特·基爾克旺、托馬斯·科赫爾、艾雅·科諾寧、巴哈爾·埃倫·庫魯、法蘭斯·蘭伯特、盧卡·蘭迪、尼克勞斯·朗、布魯諾·盧斯、羅德里戈·洛佩茲、佩妮拉·倫德伯格、伊萊·馬赫泰、菲伯斯·馬迪亞諾斯、康奇塔·馬丁、寶拉·馬特桑茲、保羅·梅洛、約爾格·邁勒、安娜·莫利納、愛德華多·蒙特羅、何塞·納特、伊恩·尼德爾曼、路易吉·尼巴利、帕諾斯·帕帕帕努、安德烈亞·皮洛尼、大衛·波拉克、約安尼斯·波利佐伊斯、菲利普·普雷肖、馬克·奎里寧、克里斯托夫·拉姆塞爾、斯特凡·倫維特、喬瓦尼·薩爾維、伊格納西奧·桑茲-桑切斯、利奧爾·夏皮拉、達格瑪·埃爾斯·斯洛特、安德烈亞斯·斯塔夫羅普洛斯、澤維爾·斯特魯伊盧、讓·蘇凡、維姆·特赫爾斯、丹妮拉·蒂穆斯、克里斯蒂亞諾·托馬西、萊昂納多·特龍貝利、弗里杜斯·范德韋登、寶拉 瓦薩洛、克萊門斯·沃爾特、尼古拉·韋斯特、格諾特·溫默
METHODOLOGICAL CONSULTANTS 方法學顧問
Ina Kopp (chief consultant), Paul Brocklehurst, Jan Wennström 伊娜·科普(首席顧問)、保羅·布羅克利赫斯特、揚·溫斯特倫
WORKSHOP ORGANIZATION 工作坊組織
European Federation of Periodontology 歐洲牙周病學聯合會
SCIENTIFIC SOCIETIES INVOLVED IN THE GUIDELINE DEVELOPMENT PROCESS 參與指南制定過程的科學學會
European Federation of Conservative Dentistry 歐洲保守牙醫聯合會
European Association of Dental Public Health 歐洲牙科公共衛生協會
European Society for Endodontology 歐洲牙髓病學會
European Prosthodontic Association 歐洲贋復牙科學會
OTHER ORGANIZATIONS INVOLVED IN THE GUIDELINE DEVELOPMENT PROCESS 參與指南制定過程的其他組織
Council of European Dentists 歐洲牙醫理事會
European Dental Hygienists’ Federation 歐洲牙科衛生師聯合會
European Dental Students’ Association 歐洲牙科學生協會
Platform for Better Oral Health in Europe 歐洲口腔健康促進平台
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