Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Pocket closure
研究概览
简要总结
The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage III/IV periodontitis.
- •Completed steps I-II periodontal therapy at least 6 weeks before.
- •Full Mouth Plaque Score less than 15% at re-evaluation.
- •Full Mouth Bleeding Score less than 15% at re-evaluation.
- •Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
- •Signed informed consent.
排除标准
- •Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- •Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
- •Pregnant or nursing women.
- •Presence of tooth mobility ≥ class
- •Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
- •Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.
研究组 & 干预措施
Fiber Retention Osseous Resective Surgery
Paramarginal incisions both on buccal and lingual/palatal sides with bone remodelling preserving the supracrestal fibers
干预措施: Fiber retention osseous resective surgery (Procedure)
Papilla preservation flap
Access flap for open flap debridement using intrasulcular incisions and papilla preservation approaches to preserve the entire interdental tissues
干预措施: Papilla preservation flap (Procedure)
Conventional surgery
Access flap for open flap debridement using a conventional modified Widman flap procedure
干预措施: Widman flap procedure (Procedure)
结局指标
主要结局
Pocket closure
时间窗: 5 years
Defined as probing pocket depth (PPD) of 3 mm or less or PPD of 4 mm with the absence of Bleeding on Probing in sites with PPD equal or more than 6 mm at baseline.
次要结局
- Mean Probing Pocket Depth changes(5 Years)
- Mean Clinical Attachment Level changes(5 years)
- Mean recession changes(5 years)
- Tooth Retention(5 years)
- Number of instrumentation re-intervention(5 years)
研究者
Mario Aimetti
Associate Professor
University of Turin, Italy