Comparative Evaluation of Clinical Efficacy of Volume Stable Xenogenic Collagen Matrix Incorporated With Injectable Platelet Rich Fibrin And De-Epithelialized Gingival Graft Along With Coronally Advanced Flap in The Management of Gingival Recession Defects – A Comparative Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1.To assess & compare the changes in the recession height from baseline to 6 months, within & between the treatment groups.
研究概览
简要总结
Gingival recession is defined as a apical migration of gingival margin to the cementoenamel junction exposing the root surface which may lead to dentinal hypersensitivity, root caries and aesthetic concerns to patients. Gold standard treatment protocol for management of gingival recession is the autologous graft obtained from palate. However donor site may not be adequate in all the subjects to manage multiple recessions. The proposed study aims to compare the clinical efficacy of volume stable xenogeneic collagen matrix incorporated with injectable platelet rich fibrin versus de-epithelized gingival graft in the treatment of gingival recession defects. If the intervention group shows similar significant results as the control group, in future we may recommend the intervention group protocol as a choice of treatment in the patients who don’t have adequate donor tissue and are fearful about second surgical site for procuring graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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.Individuals diagnosed with 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
- •Sites with probing pocket depth greater than 4mm.
- •2.Teeth with mobility and/or associated with trauma from occlusion.
- •Sites with dental caries and prosthetic restorations.
- •Patients who exhibit unacceptable oral hygiene compliance during/or after phase one periodontal therapy.
- •Pregnant and lactating women.
- •Patient known allergic response with Porcine derived substances.
- •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
1.To assess & compare the changes in the recession height from baseline to 6 months, within & between the treatment groups.
时间窗: Baseline, 3 & 6 months
2. To assess & compare the percentage of Complete root coverage achieved at 6months between the treatment groups.
时间窗: Baseline, 3 & 6 months
次要结局
- 1.To assess & compare the changes in the Gingival thickness from baseline to 6 months, within & between the treatment groups.