背景:牙周炎和种植体周围疾病是发生在口腔中的慢性炎性疾病。未经治疗,牙周炎会逐渐破坏牙齿支撑装置。种植体周围疾病发生在牙种植体周围的组织中,其特征是种植体周围粘膜发炎,随后逐渐丧失支持骨。治疗旨在清洁牙齿或牙科植入物周围的口袋,并防止对周围的软组织和骨骼造成损害,包括改善口腔卫生,危险因素控制(如鼓励戒烟)和手术干预。标准非手术治疗的关键方面是使用龈下器械(SI)(也称为鳞屑和根部平整)去除龈下生物膜。抗微生物光动力疗法(aPDT)可用作SI的辅助治疗。它使用光能杀死在aPDT之前立即用光吸收光敏剂处理的微生物。
目的:评估SI联合辅助aPDT与单纯SI或安慰剂aPDT对成人牙周炎和种植体周围疾病的影响。
方法:我们搜索了Cochrane口腔健康试验注册,中部,MEDLINE,Embase,截至2024年2月14日,另外两个数据库和两个试验登记。
方法:我们纳入了临床诊断为牙周炎的参与者的随机对照试验(RCT)(平行组和口设计),种植体周围炎或种植体周围疾病。我们比较了抗菌光动力疗法(aPDT)的辅助使用,其中在牙龈下或粘膜下器械(SI)后给予aPDT,与单独SI或SI和安慰剂aPDT的组合在活性或支持治疗阶段。
方法:我们使用了标准的Cochrane方法学程序,我们用等级来评估证据的确定性.我们优先考虑了六个结果和从基线到治疗后六个月的变化测量:探查口袋深度(PPD),探查出血(BOP),临床依恋水平(CAL),牙龈衰退(REC),口袋闭合和与aPDT相关的不良反应。我们还对骨水平的变化感兴趣(对于患有种植体周围炎的参与者),以及参与者的满意度和生活质量。
结果:我们纳入了50项RCT,其中有1407名参与者。大多数研究使用口裂研究设计;只有18项研究使用平行组设计。研究很小,参与者从10到88。在39项研究中,辅助aPDT在一个疗程中被给予,在11项研究的多次会议(两到四次会议)中,一项研究包括单次和多次会议。SI使用手动或动力驱动仪器(或两者)给出,并在辅助aPDT之前进行。5项研究在对照组中使用安慰剂aPDT,我们在荟萃分析中将这些研究与仅使用SI的研究相结合。所有研究都包括高或不清楚的偏倚风险,例如人员的选择偏差或绩效偏差(当SI由知道组分配的操作员执行时)。由于这些偏见的风险,我们降低了所有证据的确定性,以及合并效应估计中无法解释的统计学不一致或证据来自极少数参与者且置信区间(CI)显示干预组和对照组可能受益的不精确.在牙周炎的积极治疗期间,辅助aPDT与单独SI相比(44项研究)我们非常不确定在牙周炎的积极治疗期间辅助aPDT与单独SI相比是否在六个月时导致任何临床结果的改善:PPD(平均差异(MD)0.52mm,95%CI0.31至0.74;15项研究,452名参与者),防喷器(MD5.72%,95%CI1.62至9.81;5项研究,171项研究),CAL(MD0.44mm,95%CI0.24至0.64;13项研究,414名参与者)和REC(MD0.00,95%CI-0.16至0.16;4项研究,95名参与者);非常低的确定性证据。辅助aPDT和单独SI之间的任何明显差异均未被认为是临床重要的。24项研究(639名参与者)没有观察到与aPDT相关的不良反应(中度确定性证据)。没有研究报告六个月时口袋关闭,参与者满意度或生活质量。在牙周炎的支持治疗期间,辅助aPDT与单独SI相比(六项研究)我们非常不确定在牙周炎的积极治疗期间,辅助aPDT与单独SI相比是否会在六个月时导致任何临床结果的改善:PPD(MD-0.04毫米,95%CI-0.19至0.10;3项研究,125名参与者),防喷器(MD4.98%,95%CI-2.51至12.46;3项研究,127名与会者),CAL(MD0.07mm,95%CI-0.26至0.40;2项研究,85名参与者)和REC(MD-0.20毫米,95%CI-0.48至0.08;1项研究,24名参与者);确定性非常低的证据。这些发现都是不精确的,并且不包括aPDT的临床重要益处。三项研究(134名参与者)报告了不良反应:一名参与者出现脓肿,尽管目前尚不清楚这是否与aPDT有关,两项研究未观察到与aPDT相关的不良反应(中度确定性证据)。没有研究报告六个月时口袋关闭,参与者满意度或生活质量。
结论:因为证据的确定性非常低,我们无法确定辅助aPDT在牙周炎的积极或支持治疗期间是否能改善临床结果;此外,结果表明,任何改善都可能太小而不具有临床重要性.这种证据的确定性只能通过包含大量的,进行良好的RCTs进行了适当的分析,以解释随时间的结果变化或参与者内部的口口裂研究设计(或两者)。我们没有发现包括种植体周围炎在内的研究,只有一项研究包括患有种植体周围粘膜炎的人,但是这项非常小的研究报告六个月没有数据,在这一人群中,有更多辅助aPDT的证据。
BACKGROUND: Periodontitis and peri-implant diseases are chronic inflammatory conditions occurring in the mouth. Left untreated, periodontitis progressively destroys the tooth-supporting apparatus. Peri-implant diseases occur in tissues around dental implants and are characterised by inflammation in the peri-implant mucosa and subsequent progressive loss of supporting bone. Treatment aims to clean the pockets around teeth or dental implants and prevent damage to surrounding soft tissue and bone, including improvement of oral hygiene, risk factor control (e.g. encouraging cessation of smoking) and surgical interventions. The key aspect of standard non-surgical treatment is the removal of the subgingival biofilm using subgingival instrumentation (SI) (also called scaling and root planing). Antimicrobial photodynamic therapy (aPDT) can be used an adjunctive treatment to SI. It uses light energy to kill micro-organisms that have been treated with a light-absorbing photosensitising agent immediately prior to aPDT.
OBJECTIVE: To assess the effects of SI with adjunctive aPDT versus SI alone or with placebo aPDT for periodontitis and peri-implant diseases in adults.
METHODS: We searched the Cochrane Oral Health Trials Register, CENTRAL, MEDLINE, Embase, two other databases and two trials registers up to 14 February 2024.
METHODS: We included randomised controlled trials (RCTs) (both parallel-group and split-mouth design) in participants with a clinical diagnosis of periodontitis, peri-implantitis or peri-implant disease. We compared the adjunctive use of antimicrobial photodynamic therapy (aPDT), in which aPDT was given after subgingival or submucosal instrumentation (SI), versus SI alone or a combination of SI and a placebo aPDT given during the active or supportive phase of therapy.
METHODS: We used standard Cochrane methodological procedures, and we used GRADE to assess the certainty of the evidence. We prioritised six outcomes and the measure of change from baseline to six months after treatment: probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment level (CAL), gingival recession (REC), pocket closure and adverse effects related to aPDT. We were also interested in change in bone level (for participants with peri-implantitis), and participant satisfaction and quality of life.
RESULTS: We included 50 RCTs with 1407 participants. Most studies used a split-mouth study design; only 18 studies used a parallel-group design. Studies were small, ranging from 10 participants to 88. Adjunctive aPDT was given in a single session in 39 studies, in multiple sessions (between two and four sessions) in 11 studies, and one study included both single and multiple sessions. SI was given using hand or power-driven instrumentation (or both), and was carried out prior to adjunctive aPDT. Five studies used placebo aPDT in the control group and we combined these in meta-analyses with studies in which SI alone was used. All studies included high or unclear risks of bias, such as selection bias or performance bias of personnel (when SI was carried out by an operator aware of group allocation). We downgraded the certainty of all the evidence owing to these risks of bias, as well as for unexplained statistical inconsistency in the pooled effect estimates or for imprecision when evidence was derived from very few participants and confidence intervals (CI) indicated possible benefit to both intervention and control groups. Adjunctive aPDT versus SI alone during active treatment of periodontitis (44 studies) We are very uncertain whether adjunctive aPDT during active treatment of periodontitis leads to improvement in any clinical outcomes at six months when compared to SI alone: PPD (mean difference (MD) 0.52 mm, 95% CI 0.31 to 0.74; 15 studies, 452 participants), BOP (MD 5.72%, 95% CI 1.62 to 9.81; 5 studies, 171 studies), CAL (MD 0.44 mm, 95% CI 0.24 to 0.64; 13 studies, 414 participants) and REC (MD 0.00, 95% CI -0.16 to 0.16; 4 studies, 95 participants); very low-certainty evidence. Any apparent differences between adjunctive aPDT and SI alone were not judged to be clinically important. Twenty-four studies (639 participants) observed no adverse effects related to aPDT (moderate-certainty evidence). No studies reported pocket closure at six months, participant satisfaction or quality of life. Adjunctive aPDT versus SI alone during supportive treatment of periodontitis (six studies) We were very uncertain whether adjunctive aPDT during active treatment of periodontitis leads to improvement in any clinical outcomes at six months when compared to SI alone: PPD (MD -0.04 mm, 95% CI -0.19 to 0.10; 3 studies, 125 participants), BOP (MD 4.98%, 95% CI -2.51 to 12.46; 3 studies, 127 participants), CAL (MD 0.07 mm, 95% CI -0.26 to 0.40; 2 studies, 85 participants) and REC (MD -0.20 mm, 95% CI -0.48 to 0.08; 1 study, 24 participants); very low-certainty evidence. These findings were all imprecise and included no clinically important benefits for aPDT. Three studies (134 participants) reported adverse effects: a single participant developed an abscess, though it is not evident whether this was related to aPDT, and two studies observed no adverse effects related to aPDT (moderate-certainty evidence). No studies reported pocket closure at six months, participant satisfaction or quality of life.
CONCLUSIONS: Because the certainty of the evidence is very low, we cannot be sure if adjunctive aPDT leads to improved clinical outcomes during the active or supportive treatment of periodontitis; moreover, results suggest that any improvements may be too small to be clinically important. The certainty of this evidence can only be increased by the inclusion of large, well-conducted RCTs that are appropriately analysed to account for change in outcome over time or within-participant split-mouth study designs (or both). We found no studies including people with peri-implantitis, and only one study including people with peri-implant mucositis, but this very small study reported no data at six months, warranting more evidence for adjunctive aPDT in this population group.