NCT05456555已完成不适用
The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial
University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Clinical attachment level change
研究概览
简要总结
The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of periodontitis stage III or IV;
- •presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
- •a full-mouth plaque score and full-mouth bleeding score <15% at the time of the experimental procedure;
- •signed informed consent.
排除标准
- •relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
- •consumption of drugs known to affect periodontal status;
- •pregnancy and lactation;
- •third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
- •heavy smokers >10 cigarettes per day.
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)
研究者
Mario Aimetti
Professor
University of Turin, Italy
研究点 (2)
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