Evaluation of effectiveness of Platelet Rich Fibrin Matrix (PRFM) membrane and Platelet Rich Fibrin (PRF) membrane using Vestibular Incision Subperiosteal Tunnel Access (VISTA) Approach Technique for the Treatment of Multiple Gingival Recession in Humans- A Clinical Study.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- root coverage
研究概览
简要总结
The present study will be undertaken to evaluate the effectiveness of Platelet rich fibrin matrix (PRFM) membrane in Miller Class I and II multiple gingival recession defects with the following objectives:
- To evaluate the effectiveness of Platelet rich fibrin matrix (PRFM) membrane using Vestibular Incision Subperiosteal Tunnel Access technique with respect to root coverage, gains in clinical attachment level, gingival thickness and improvement in the width of the keratinized gingiva.
- To evaluate the effectiveness of Platelet rich fibrin (PRF) membrane using Vestibular Incision Subperiosteal Tunnel Access technique in terms of root coverage, gain in clinical attachment level, gingival thickness and improvement in the width of keratinized gingiva.
- To compare the effectiveness of PRFM membrane with that of PRF membrane using Vestibular Incision Subperiosteal Tunnel Access technique in terms of root coverage and gain in clinical attachment level, gingival thickness as well as improvement in the width of keratinized gingiva.
- Inclusion Criteria:
-
- Presence of multiple gingival recession (more than one) defects on the labial/ buccal surfaces of the teeth either in maxilla or mandible classified as either Miller’s Class I or II.
2. Presence of ≥ 2 mm gingival recession depth
3. Radiographic evidence of sufficient interdental bone (the distance between the crestal bone and cementoenamel junction as ≤ 2mm).
4. Presence of adequate width of keratinized gingiva apical to recession.
Exclusion Criteria:
1. Patients using tobacco products and smokers.
2. Un-cooperative patients.
3. Patients with unacceptable oral hygiene after phase I therapy and showing plaque score ≥1.
4. History of periodontal surgical treatment in quadrant selected for the study.
5. Pregnant lady or lactating mother.
6. Presence of badly caries teeth
7. Presence of mobile teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: 1.Presence of multiple gingival recession (more than one) defects on the labial/ buccal surfaces of the teeth either in maxilla or mandible classified as either Miller’s Class I or II.
- •2.Presence of ≥ 2 mm gingival recession depth 3.Radiographic evidence of sufficient interdental bone (the distance between the crestal bone and cementoenamel junction as ≤ 2mm).
- •4.Presence of adequate width of keratinized gingiva apical to recession.
排除标准
- •Exclusion Criteria: 1.Patients using tobacco products and smokers.
- •2.Un-cooperative patients.
- •3.Patients with unacceptable oral hygiene after phase I therapy and showing plaque score ≥
- •4.History of periodontal surgical treatment in quadrant selected for the study.
- •5.Pregnant lady or lactating mother.
- •6.Presence of badly caries teeth 7.Presence of mobile teeth.
结局指标
主要结局
root coverage
时间窗: 3 and 6 months
次要结局
- gains in clinical attachment level, gingival thickness and improvement in the width of the keratinized gingiva(3 and 6 months)