跳至主要内容
临床试验/CTRI/2021/05/033564
CTRI/2021/05/033564已完成不适用

“Comparative evaluation of clinicalefficacy of Leukocyte rich Platelet Rich Fibrin (L-PRF) andAdvanced Platelet Rich Fibrin (A-PRF) in the management ofgingival 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5月25日最近更新:
适应症

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
1. 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. Research in the South Indian population found approximately 40-68% of the subjects had at least one or more gingival recession defects. 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.

Platelet concentrates aim at extracting all the potential elements present in the collected blood sample and providing supra-physiological concentration at the surgical site to accelerate the healing process and induce regeneration of lost tissues. The second generation platelet concentrates are formed by natural polymerization during centrifugation, resulting in a three-dimensional fibrin architecture with equilateral junctions mimicking the extracellular matrix structure, offering flexibility and elasticity. Low speed centrifugation concept (LSCC) by Choukroun et al 2014 led to the evolution of Advanced platelet rich fibrins (A-PRF, A-PRF+)

Various invitro and invivo studies had shown the positive outcomes with A-PRF in hard and soft tissue regeneration. However, 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 L-PRF and 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
Participant and 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

  • •Systematically healthy individuals manifesting with millers class I and II recession defects in maxillary anterior teeth and premolars.
  • •Minimum recession depth ≥ 2mm.

排除标准

  • •Millers class III and 1V gingival recession
  • •Recession sites with probing depth ≥ 4mm and teeth with mobility
  • •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

1. Changes in Recession height

时间窗: Baseline, 3 months, 6 months

2. Root coverage percentage

时间窗: Baseline, 3 months, 6 months

次要结局

  • 1. Changes in gingival biotype(Baseline, 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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