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临床试验/CTRI/2024/12/078512
CTRI/2024/12/078512已完成3 期

Residual alveolar ridge height and wound healing after conventional vestibuloplasty versus PRF membrane as an adjunct to conventional vestibuloplasty : A pilot comparative clinical study.

Dr. Muskan Gupta1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
To evaluate the effectiveness of PRF membrane as an adjunct to conventional vestibuloplasty in increasing the residual alveolar ridge height.

研究概览

简要总结

  • Removable dentures are a common treatment for optimal improvement in function and esthetics in patients with edentulism. In subjects with high frenal attachment or shallow depth of vestibule , pre-prosthetic surgeries like vestibuloplasty and frenectomy play an imperative role in preparing the oral environment for a better denture stability.
  • Vestibuloplasty surgeries are usually performed to provide adequate depth in labial or lingual vestibular area for denture flange.
  • Several techniques for vestibuloplasty have been proposed such as conventional vestibuloplasty, Kazanjian technique and lip-switch technique, grafting vestibuloplasty with each one has its own advantages and disadvantages but the major disadvantage being relapse of the vestibular depth to the original position.
  • In 2000, platelet-rich fibrin (PRF) as the second generation of autologous platelet concentrates (APCs) caught extreme attention for various oral application.
  • PRF has no anti-coagulant agents and has excellent anti-bacterial , antiinflammatory , and regenerative potentials.
  • To reduce the shortcomings of conventional vestibuloplasty procedures, PRF membrane can be employed for covering the exposed area. Therefore, there would be no need for further skin or mucosal graft harvesting; besides, the epithelialization rate of the wound can be accelerated.
  • The ease-of-applicability of this natural biomaterial can ultimately increase its acceptance among surgeons and patients, while it leaves patients with less complications after surgery.

The present study aims at comparing the residual rodge height and wound healing after conventional vestibuloplasty versus PRF membrane as an adjunct to conventional vestibuloplasty.

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 Blinded

入排标准

年龄范围
60.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Completely edentulous mandibular arch.
  • Class III and class IV residual alveolar ridge height.

排除标准

  • Systemic diseases, pregnancy and lactation.
  • Smoking, use of tobacco in any form and recreational drug users.

结局指标

主要结局

To evaluate the effectiveness of PRF membrane as an adjunct to conventional vestibuloplasty in increasing the residual alveolar ridge height.

时间窗: Baseline, 1 month, 3 months

次要结局

  • To evaluate wound healing after conventional vestibuloplasty versus PRF(membrane as an adjunct to conventional vestibuloplasty.)

研究者

发起方
Dr. Muskan Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Muskan Gupta

JSS Academy of Higher Education and Research

研究点 (1)

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