Background and AimClinical practice guidelines suggest access flap surgery for managing deep residual pockets after steps 1 and 2 of periodontal therapy. Papilla‐preservation flap surgery (PPFS) is the least invasive approach to access and instrument biofilm‐contaminated root surfaces. Endoscopic‐assisted subgingival debridement (EASD) may enhance the outcomes of repeated instrumentation and provide a minimally invasive non‐surgical alternative.MethodsThis was a single‐blind, controlled, randomized, parallel‐group, non‐inferiority 12‐month trial comparing EASD with PPFS. Male and female adults with generalized stage III periodontitis and persistent periodontal pockets associated with an intrabony defect after steps 1 and 2 of periodontal therapy were recruited at Prince Philip Dental Hospital. Inter‐group differences in clinical attachment level (CAL) changes at 12 months were the primary outcome. Secondary outcomes included pocket resolution (no pocket > 5 mm and no pocket > 4 with bleeding on probing), radiographic bone changes, treatment time, early wound healing and quality‐of‐life measurements.ResultsSixty‐two subjects (30 EASD and 32 PPFS) were included in the intention‐to‐treat analysis. CAL gains were 2.0 ± 1.0 and 1.8 ± 1.0 mm for test and controls, respectively. The 95% CI of the inter‐group difference was −0.3 to 0.8 mm and within the stipulated 1‐mm non‐inferiority margin. No inter‐group differences were observed (i) in pocket resolution, which was achieved in more than 87% of cases for all groups/time points, and (ii) in radiographic bone healing. The treatment time was significantly shorter for EASD than for PPFS. Better early wound healing index scores were observed for EASD. No inter‐group differences in pain, quality of life or safety were detected.ConclusionsEASD was not inferior to PPFS for managing residual pockets associated with intrabony defects. The observed outcome profile supports additional developments and studies to validate EASD as an alternative to surgery for isolated persistent pockets (ChiCTR‐INR‐16008407).

中文翻译：

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骨内缺损相关深部残留牙周袋的内窥镜再器械操作不劣于视保留皮瓣手术：一项随机试验


背景和目标临床实践指南建议在牙周治疗第 1 步和第 2 步后使用通路皮瓣手术来管理深残余袋。保留皮瓣手术 （PPFS） 是进入和器械受生物膜污染的根表面的侵入性最小的方法。内窥镜辅助龈下清创术 （EASD） 可能会改善重复器械操作的结果，并提供一种微创非手术替代方案。方法这是一项为期 12 个月的单盲、对照、随机、平行组、非劣效性试验，比较 EASD 与 PPFS。菲腊亲王牙科医院招募了患有全身性 III 期牙周炎和与牙周治疗第 1 步和第 2 步骨内缺损相关的持续性牙周袋的男性和女性成人。12 个月时临床依恋水平 （CAL） 变化的组间差异是主要结局。次要结局包括牙周袋分辨率（无牙周袋 > 5 mm，无牙周袋 > 4，探诊出血）、影像学骨骼变化、治疗时间、早期伤口愈合和生活质量测量。结果62 名受试者 （30 名 EASD 和 32 名 PPFS） 被纳入意向治疗分析。测试和对照的 CAL 增益分别为 2.0 ± 1.0 和 1.8 ± 1.0 mm。组间差异的 95% CI 为 -0.3 至 0.8 mm，在规定的 1 mm 非劣效性范围内。未观察到组间差异 （i） 口袋分辨率，在所有组/时间点的 87% 以上的病例中实现了差异，以及 （ii） 放射学骨愈合。EASD 的治疗时间显著短于 PPFS。观察到 EASD 的早期伤口愈合指数评分更好。未检测到疼痛、生活质量或安全性的组间差异。结论EASD 在处理与骨内缺损相关的残余袋方面并不劣于 PPFS。观察到的结果概况支持其他开发和研究，以验证 EASD 作为孤立性持续性口袋手术的替代方案 （ChiCTR-INR-16008407）。