跳至主要内容
临床试验/CTRI/2021/05/033726
CTRI/2021/05/033726已完成不适用

“Comparative Evaluation of Clinical Efficacy of Subepithelial Connective Tissue Graft (SCTG) and Advanced Platelet Rich Fibrin (A-PRF) in the Management of Gingival Recession Defects-A Randomized controlled trialâ€

Dr Anupama Tadepalli1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
To assess and compare the changes in Recession height

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 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 A-PRF in the treatment of gingival recession defects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • 1.Systematically healthy patients manifesting with millers class I and II recession defects in maxillary anteriors and premolars
  • Minimum recession height ≥ 2mm.

排除标准

  • Millers class III and 1V gingival recession
  • Recession sites with probing depth ≥ 4mm and mobile teeth
  • Teeth with prosthetic restoration
  • Anaemic patients
  • Pregnant and lactating women
  • Patients with poor oral hygiene
  • Systemic condition /disease/ any medication influencing the periodontal therapy and disease.

结局指标

主要结局

To assess and compare the changes in Recession height

时间窗: Baseline, 3 months and 6 months

次要结局

  • To assess and compare the changes in gingival biotype(Baseline, 3 months and 6 months)

研究者

发起方
Dr Anupama Tadepalli
申办方类型
Other [Self funded]

研究点 (1)

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