Evaluation Of Clinical Efficacy Of Xenogenic Collagen Matrix Loaded With Injectable-PRF And PRF Membrane Obtained By Horizontal Spin Protocol Along With Coronally Advanced Flap In The Management Of Gingival Recession Defects – A Prospective Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 2.To assess and compare the percentage of Complete root coverage achieved at 6months between the treatment groups.
研究概览
简要总结
Gingival recession is defined as the apical displacement of gingival margin to the cementoenamel junction exposing the root surfaces which may lead to dentinal hypersensitivity, root caries and aesthetic concerns to patients. Connective tissue graft along with coronally advanced flap is considered as the gold standard treatment protocol in the management of gingival recession. However , due to drawbacks of connective tissue grafts like palatal morbidity as a result of secondary surgical site and patient’s fear of pain the proposed study aims to compare the clinical efficacy of volume stable xenogenic collagen matrix incorporated with injectable platelet rich fibrin versus platelet rich fibrin obtained by horizontal spin protocol in the treatment of gingival recession defects. If both the groups shows similar significant results, in future we may recommend the groups protocol as a choice of treatment in the management of gingival recession defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cairo’s RT1 & RT2 class of recession defects in maxillary anteriors and premolars.
- •2.Sites with minimum depth of recession greater then or equal to 2mm.
- •3.Isolated or multiple adjoining recession involving less than or equal to 3 teeth.
排除标准
- •1.Sites with probing pocket depth greater than 4mm.
- •2.Teeth with mobility and/or associated with trauma from occlusion.
- •3.Sites with dental caries and prosthetic restorations.
- •4.Patients who exhibit unacceptable oral hygiene compliance during/or after phase one periodontal therapy.
- •6.Pregnant and lactating women.
- •8.Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
结局指标
主要结局
2.To assess and compare the percentage of Complete root coverage achieved at 6months between the treatment groups.
时间窗: Baseline and 6months
1.To assess & compare the changes in the recession height from baseline to 6 months, within & between the treatment groups.
时间窗: Baseline and 6months
次要结局
- 1.To assess & compare the changes in the Gingival thickness from baseline to 6 months, within & between the treatment groups.(Baseline and 6months)