Comparative Clinical Evaluation of Coronally Advanced Flap With Platelet Rich Fibrin Membrane and Chorion Membrane in the Treatment of Human Gingival Recession
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recession depth (RD)
研究概览
简要总结
The present study was a double-blind, randomised, controlled clinical trial with a parallel design, comparing the coronally advanced flap (CAF) with platelet-rich fibrin (PRF) and chorion membrane (CM) for the treatment of isolated gingival recession defects. A total of 50 patients were randomly divided into; Experimental site A: Twenty five sites were treated with coronally advanced flap (CAF) and platelet-rich fibrin (PRF) membrane; Experimental site B: Twenty five sites were treated with coronally advanced flap (CAF) and chorion membrane (CM)The study was conducted in accordance with the Declaration of Helsinki, protocol was developed and ethical clearance was obtained from the Institutional Ethics Committee, Institute of Dental Sciences, Bareilly, India [IDS/ETHCC/14/08]. As per protocol, a study was conducted in five phases: (1) initial screening; (2) initial therapy and clinical measurements; (3) surgical therapy; (4) maintenance phase; and (5) post-operative evaluation after 1 month, 3 months, and 6 months.
详细描述
Platelet-rich fibrin (PRF), a second-generation platelet concentrate, accelerates soft and hard tissue regeneration. Chorion membrane, of fetal origin, has wound-modulating properties. This study aimed to evaluate and compare the clinical outcomes of PRF and chorion membrane in treating isolated Miller's Class I or II gingival recession defects. Fifty recession defects in 50 patients were randomly treated with a coronally advanced flap (CAF) and PRF membrane (site A, n = 25) or CAF with chorion membrane (site B, n = 25). Clinical parameters recorded at baseline, 1, 3, and 6 months included recession depth (RD), recession width (RW), clinical attachment level (CAL), width of keratinised gingiva (WKG), plaque index (PI), gingival index (GI), and gingival biotype. Statistical analysis compared outcomes across follow-up intervals. At six months, both groups demonstrated significant improvements in RD, RW, CAL, WKG, PI, and GI compared with baseline. Mean percentage root coverage was 86.76 ± 13.76 in the PRF group and 82.89 ± 15.65 in the chorion group, with no statistically significant difference between them. Sites with an initial thin biotype showed conversion to a thick biotype in both groups. Both PRF and chorion membrane demonstrated predictable effectiveness for managing isolated recession defects, with comparable outcomes. Longitudinal studies are needed to confirm these findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-35 years
- •In good general health
- •Isolated Miller's Class I or II gingival recession ≥ 2 mm
- •≥ 1 mm keratinised tissue apical to root exposure
- •Identifiable CEJ (cementoenamel junction)
排除标准
- •Poor oral hygiene after Phase I therapy
- •Smoking or alcohol use
- •Occlusal disharmony
- •Parafunctional habits
- •Non-vital or endodontically treated teeth
- •Caries, restorations, or crowns at the CEJ
- •Frenum pull at the attached gingiva
- •Previous surgery in the area
结局指标
主要结局
Recession depth (RD)
时间窗: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
Measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin
Assessment of gingival biotype
时间窗: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
Evaluated based on the transparency of the probe through the gingival margin while probing the sulcus at the midfacial aspect of teeth
Recession width (RW)
时间窗: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
Measured between mesial and distal papillae across the buccal surface at the CEJ level
Clinical attachment level (CAL)
时间窗: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits:
Measured from the CEJ to the bottom of the gingival sulcus;
Width of keratinized gingiva (WKG)
时间窗: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
Measured from the gingival margin to the mucogingival junction (MGJ)
次要结局
未报告次要终点
研究者
Bimmi Tripathi
Doctor-primary Investigator
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India