Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical attachment level change
研究概览
简要总结
In this double-blinded randomized clinical trial, patients presenting periodontal intrabony defects requiring regenerative surgery and showing BoP will be included. Experimental sites at T-0 will be randomly treated with gentle debridement and administration of local DOX (test group) or with debridement alone (control group). After 2 weeks (T-1), defects will be treated by means of minimally invasive surgical technique. 14 days after the surgery (T-2) the EHI will be evaluated by a blinded examiner. Patients will be recalled each 2 months up to 12 months (T-3). At T-0, T-1 and T-3 periodontal examination and radiographic analysis will be done.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);
- •2) FMPS and FMBS < 15% at the time of enrollment;
- •3) etiological periodontal therapy completed at least 3 months prior to screening;
- •4) presence of one natural tooth having a vertical defect with residual PPD ≥ 6 mm and a radiographic intrabony component ≥ 3 mm and BoP + requiring periodontal regenerative surgery.
排除标准
- •1) age < 18 years;
- •2) smoking habits (> 10 cigarettes/day);
- •3) contraindications for periodontal surgery;
- •4) systemic diseases affecting periodontal healing;
- •5) pregnancy and lactation;
- •6) history of periodontal surgery at the experimental teeth;
- •7) allergies to doxycycline and tetracyclines;
- •8) assumption of antibiotics in the last 3 months.
结局指标
主要结局
Clinical attachment level change
时间窗: 12 months
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
次要结局
- Radiographic bone level change(12 months)
- Probing pocket depth change(12 months)
- Bleeding on probing reduction(12 months)