Evaluation of the efficacy of Guided tissue regeneration using autologous heat compressed platelet-rich-fibrin membrane compared to subepithelial connective tissue graft in the management of RT1 marginal tissue recession : A Randomized controlled study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Recession depth reduction [Time Frame:6 months]
研究概览
简要总结
This randomized controlled clinical study aims to evaluate and compare the effectiveness of two guided tissue regeneration techniques in treating localized marginal gingival recession . A total of 32 subjects will be enrolled and randomly assigned into two equal groups
Active Comparator Group will beTreated with a coronally advanced flap in combination with autologous heat-compressed platelet-rich fibrin membrane
Control Group will beTreated with a coronally advanced flap along with a subepithelial connective tissue graft , which is the gold standard.
The goal is to assess clinical outcomes such as root coverage, tissue thickness, and esthetic integration, determining whether heat compressed platelet-rich fibrin membrane can serve as a viable alternative to subepithelial connective tissue graft in the management of localized marginal tissue recession defects.
Additionally , biomarkers like Angiogenin and Human Cementum Protein will evaluate vascularization and healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.localised gingival recession of at least 2mm in depth with minimum width of attached gingiva as more than 3mm apical to recession 2.presence of identifiable buccal cemento-enamel-junction without any carious, non carious, cervical lesion or restoration 3.in good general health(ASA 1) 4.palatal mucosal thickness more than 2.5 mm as assesses by trans gingival probing which serves as donor site.
排除标准
- •1.pregnancy and lactating women 2.teeth with evidence of a pulpal pathology and a non-vital tooth 3.teeth that had periodontal surgical procedure for root coverage in the last 2 years 4.subjects who are active smokers at the time of screening.
结局指标
主要结局
1. Recession depth reduction [Time Frame:6 months]
时间窗: 0-6 months
-Measured from the reference stent margin to the most apical extension of the gingival margin; will be measured in mm
时间窗: 0-6 months
2.Mean root coverage (MRC), calculated as
时间窗: 0-6 months
[(Baseline RD) – (6 months RD)/Baseline RD] × 100%.
时间窗: 0-6 months
3.complete root coverage (CRC), calculated as the percentage treated site with 100% coverage
时间窗: 0-6 months
次要结局
- 1.Pain assessment at the donor site [ Time Frame: 7 days](-Visual Analogue Scale)
研究者
Dr Smitha K
Government dental college and research institute