Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gingival thickness
研究概览
简要总结
The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.
A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a class RT1 recession;
- •age > 18 years;
- •systemic health conditions that do not affect the periodontium;
- •Non smoker;
- •FMPS and FMBS values < 20% before the surgical procedure;
- •absence of implants or subgingival restorations in the sites to be treated;
- •presence of adequate tissue distal to the last maxillary molar.
排除标准
- 未提供
结局指标
主要结局
Gingival thickness
时间窗: 12 months
Gingival tissue thickness 2 mm apical to the recession
次要结局
- Pocket depth(12 months)
- Clinical attachment level(12 months)
- Keratinized tissue height(12 months)
- Gingival recession(12 months)
- Complete root coverage(12 months)
研究者
Michele Paolantonio
Full time professor
G. d'Annunzio University