Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II.
This study is a randomized-controlled clinical trial of 6 months duration.
详细描述
According to the medical databases, there are limited randomized clinical trials comparing xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a possible alternative to connective tissue graft.
The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root coverage using the tunnel technique with the collagen matrix and the same technique with CTG for the treatment of multiple recessions Miller class I and II.
Twenty eight patients are enrolled in the study. Patients in the test group are treated with xenogenic collagen matrix using the tunnel technique whereas patients in the control group with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the surgery.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.
排除标准
- •Approximal Plaque Index (API) > 15%,
- •Sulcus Bleeding Index (SBI) > 10%,
- •Systemic diseases with compromised healing potential or infectious diseases,
- •Untreated periodontal conditions,
- •Pregnant and lactating females.
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: 6 months
Distance from the cemento enamel junction to the deepest point of the gingival sulcus
次要结局
- Recession depth (RD)(6 months)
- Recession width (RW)(6 months)
- Width of keratinized tissue (KTW)(6 months)
- Recession area (RA)(6 months)
- the average percentage of root coverage (ARC)(6 months)
- The complete coverage of recessions (CRC)(6 months)
研究者
Lukasz Gilowski
PhD DDS
Medical University of Silesia