Conservative Surgery with Modified Widman Flap Vs Conservative Surgery with 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
- 80
- 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 conservative surgery with or without papilla preservation technique 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 of less than 15% at re-evaluation.
- •Full mouth bleeding score of less than 15% at re-evaluation.
- •Sextant with residual probing pocket depth (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 2.
结局指标
主要结局
Pocket closure
时间窗: 5 years
Defined as Probing pocket depth of 3 mm or less or Probing pocket depth of 4 mm with the absence of Bleeding on Probing in sites with Probing pocket depth of 6 mm or more at baseline.
次要结局
- Tooth Retention(5 years)
- Number of instrumentation re-intervention(5 years)
- Mean Probing Pocket Depth changes(5 years)
- Mean Clinical Attachment Level changes(5 years)
- Mean recession changes(5 years)
研究者
Mario Aimetti
Associate Professor
University of Turin, Italy