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临床试验/CTRI/2024/05/068095
CTRI/2024/05/068095尚未招募4 期

Comparative Evaluation of Rate of Mucosalization of Residual Raw Areas Post Palatoplasty With Use of Buccal Fat Pad in Cleft Palate – A Randomised Controlled Study

MGM Dental College and Hospital Kamothe navi mumbai1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
rate of mucosalization

研究概览

简要总结

Palatoplasty is surgery of cleft palate patients to reconstruct the altered intraoral anatomy and achieve normal functions. Several surgical techniques have been described for cleft palate, including von Langenbeck, Bardach’s and Furlow’s techniques. The goal of the surgery is to restore normal anatomy, which helps in feeding to prevent nasal regurgitation and prevention of articulation issues secondary to the removal of air through the nose. The techniques used to close the defect may result in bare bony areas on the hard palate after the elevation of mucoperiosteal flaps and their subsequent medial mobilization. The defect lateral to mucoperiosteal flaps closure is sometimes covered with sterile gauze soaked with soft paraffin or tincture of benzoin or are left open for mucosalization by means of secondary intention, which leads to discomfort to the patient.  The defect usually heals by secondary intention and scarring.

Buccal fat pad is one of several encapsulated fat masses in cheek which is highly vascularised and easy to harvest and may be used as flap.

Aim of this study is to evaluate the advantages of using BFP as adjuvant to palatoplasty to cover residual raw area defects created during palatoplasty.

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
12.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Participants with cleft palate veau’s type I,II,III,IV 2) Participants under age group 12 months to 18 years of age requiring cleft palate surgery 3) Participants with parenteral consent upto 7 years of age, parenteral consent and assent from 7 years to 18 years of age willing to be part of study.

排除标准

  • Participants in which buccal fat pad has been previously used.
  • Participants having systemic bleeding disorders.

结局指标

主要结局

rate of mucosalization

时间窗: 7th day, 14th day,16th day,18th day,20th day,22nd day,24th day,26th day,28th day

次要结局

  • incidence of fistula formation(6 months)
  • incidence of bleeding(0hr,3hrs,6hrs,12hrs,24hrs)

研究者

发起方
MGM Dental College and Hospital Kamothe navi mumbai
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Ritesh Chhatwani

MGM Dental College and Hospital Kamothe NAVI MUMBAI

研究点 (1)

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