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临床试验/CTRI/2025/07/090171
CTRI/2025/07/090171尚未招募不适用

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

Dr Aashlesha Raut1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月15日最近更新:

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

发起方
Dr Aashlesha Raut
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrAashlesha Sureshkumar Raut

Dr D Y Patil Dental College and Hospital

研究点 (1)

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