Comparative Evaluation of Volume Stable Collagen Matrix and Platelet Rich Fibrin Using Modified Coronally Advanced Flap Technique in The Management of Isolated Gingival Recession Defects – A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Gingival Recession Depth, Clinical attachment level ,
研究概览
简要总结
Aim: This study aimed to evaluate and compare the clinical efficacy of Volume Stable Collagen Matrix (VSCM) and Platelet-Rich Fibrin (PRF) using the Modified Coronally Advanced Flap (MCAF) in managing Isolated Gingival Recession Defects.
**Methods:**In this split-mouth interventional clinical study, 10 patients with Cairo’s RT1 single-tooth bilateral gingival recession is to be enrolled, and a total of 20 recession sites will be allocated to either the Test (VSCM + MCAF; n = 10 sites) and the contralateral site as Control (PRF + MCAF; n = 10 sites). Primary clinical parameters will be assessed - gingival recession depth , clinical attachment level , and percentage of root coverage. Secondary parameters included gingival index , plaque index , probing depth, keratinized tissue width , gingival thickness , and the Root Coverage Esthetic Score . All measurements will be recorded at baseline and 6 months postoperatively. Descriptive statistics were calculated for mean and standard deviation. Intragroup comparisons will be performed using paired t-tests, while intergroup comparisons will be analysed using unpaired t-tests. Statistical significance set at p < 0.05 (two-tailed) with a 95% confidence interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Age group of 20 to 60 years Presence of Cairo‘s Recession Type 1 defects in maxillary anterior and premolars region.
- •Presence of single tooth gingival recession sites bilaterally.
- •CEJ visible on the recessed teeth.
- •Presence of at least 1mm of residual keratinized tissue around target tooth.
- •Full mouth Plaque score less than 20 percent Subjects with healthy or effectively treated periodontal conditions.
- •Patients willing to comply with all study related procedures.
- •Patients with adequate Platelet Count.
排除标准
- •Pregnant or Lactating women.
- •Tobacco in any form.
- •Presence of Recession in Mandibular teeth.
- •Patients with known history of any systemic diseases like hypertension diabetes HIV bone metabolic disorders radiation therapy immunosuppressive therapy cancer.
结局指标
主要结局
Gingival Recession Depth, Clinical attachment level ,
时间窗: Gingival recession depth and Clinical attachment level at baseline and 6 Months. | Percentage of root coverage at 6 months.
Percentage of root coverage
时间窗: Gingival recession depth and Clinical attachment level at baseline and 6 Months. | Percentage of root coverage at 6 months.
次要结局
- gingival index (GI), plaque index (PI), probing depth (PD), keratinized tissue width (KTW), gingival thickness (GT), and the Root Coverage Esthetic Score (RES).(Baselien and 6 months)
研究者
DrAashlesha Sureshkumar Raut
Dr D Y Patil Dental College and Hospital
