Comparative valuation of outcomes of xenogeneic pericardial collagen membrane enriched with injectable platelet rich fibrin(i-prf) and connective tissue graft in the treatment of gingival recession- A prospective clinical study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within XCM+i-PRF group.
研究概览
简要总结
Gingival recession is a prevalent periodontal condition where the apical migration of gingival tissue causes exposure of the root surface and results in hypersensitivity, root caries , esthetic concerns to patients. The coronally advanced flap (CAF) along with connective tissue graft (CTG) is one of the most effective techniques for the management of Miller Class I and II recessions because it offers excellent esthetic results, highest root coverage. However, in patients with multiple gingival recession defects and having thin gingival phenotype, harvesting CTGs of adequate dimensions are clinically challenging due to the limited donor area. Recently the allogeneic or xenogeneic membranes or matrices have been employed along with platelet concentrates to improve root coverage and as an alternative treatment protocol to CTG . In this study we are proposing to compare the efficacy of combination of xenogeneic pericardial membrane and injectable platelet concentrate with de-epithelized free gingival graft tissue along with coronally advanced flap in management of maxillary gingival recession.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy subjects with an age range of 25-50 years.
- •Individuals diagnosed with recession defects in maxillary anteriors and premolars that is the Cairo’s RT1, RT2 classes of recession
- •Sites with minimum depth of recession more or equal to 4mm
- •Isolated or multiple adjoining recession involving less or equal to 3 teeth.
排除标准
- •Sites with probing pocket depth ≥4mm.
- •2.Teeth with mobility and/or associated with trauma from occlusion.
- •Sites with dental caries and prosthetic restorations.
- •4.Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
- •6.Pregnant and lactating women.
- •7.Patient known allergic response with xenogeneic derived substances.
- •8.Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
- •9.Patients with systemic conditions or disease influencing the course of periodontal disease and therapy.
结局指标
主要结局
1. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within XCM+i-PRF group.
时间窗: baseline and 6months
2. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+DFGG group.
时间窗: baseline and 6months
3. To assess and compare the changes in the recession height from baseline to 6 months between XCM+i-PRF and CAF+DFGG groups.
时间窗: baseline and 6months
次要结局
- 1. To assess and compare the percentage of complete root coverage (CRC%) achieved at 6 months between XCM+i-PRF and CAF+DFGG group.(2. To assess and compare the patient perception regarding pain following the treatment modalities by using visual analogue scale score (VAS-P))
研究者
Kiran choudhary
SRM dental college