Comparative evaluation of the clinical efficacy of bi layered platelet-rich fibrin membrane obtained by low speed centrifugation concept in the management of gingival recession: Randomized controlled clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 1.To assess and compare the changes in Recession height (RH) between the study groups at baseline and 6 months follow up.
研究概览
简要总结
Gingival recession is described as apical migration of the free gingival margin relative to the cemento enamel junction leading to root exposure. The prevalence of mid-buccal recession defects was 91.6% as indicated in a recent epidemiological study conducted by NHANES 2020.Gingival recession is often associated with dentinal hypersensitivity, esthetic issues and also root caries. Periodontal plastic procedures aim to achieve complete root coverage while enhancing aesthetics by integrating mucosa and keratinized gingiva with adjacent tissues.
Periodontal wound healing is a complex biological mechanism where multiple cellular events occur concurrently leading to repair or regeneration.Platelets are the initial cells involved in the wound healing process. Upon activation, they release various bioactive molecules, cytokines, and adhesive proteins stimulating inflammatory cells to populate in the surgical area thereby setting the pace for the wound healing process.
A-PRF obtained by centrifugation protocol of 1500rpm for 14min at 200G, exhibited porous fibrin structure with larger interfibrinous space incorporating quantitatively more platelets and inflammatory cells, evenly distributed all through the matrix releasing significantly increased growth factor proteins (VEGF, PDGF, TGF-β, IGF and EGF). A-PRF was found to contain increased levels of VEGF, responsible for neoangiogenesis, monocytes as a source for BMP’s and fibronectin for extracellular matrix formation. The potential benefit of multilayer advanced platelet rich fibrin in management of gingival recession has not yet been established. The aim of this clinical study was to evaluate and compare the clinical efficacy of conventional gold standard connective tissue graft and single/ bi layered A-PRF in the treatment of gingival recession defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Cairo’s RT1 & RT2 recession defects in maxillary anteriors and premolars
- •Minimum recession depth ≥ 2mm.
排除标准
- •Recession sites with probing depth ≥ 4mm and mobile teeth
- •Teeth with prosthetic restorations
- •Anemic patients
- •Individuals with Platelet disorders
- •Individuals with infectious diseases
- •Patients with poor oral hygiene
- •Systemic condition /disease/any medication influencing the periodontal therapy and disease.
结局指标
主要结局
1.To assess and compare the changes in Recession height (RH) between the study groups at baseline and 6 months follow up.
时间窗: Baseline, 3 months and 6 months
2. To compare the mean Root coverage% (RC%) between the study groups at 6 months follow up.
时间窗: Baseline, 3 months and 6 months
次要结局
- 1. To evaluate the comparative changes in Gingival thickness (GT) between the study groups at baseline and 6 months follow up.(2. To evaluate the comparative changes in Width of keratinized tissue (WKT) between the study groups at baseline and 6 months follow up)