跳至主要内容
临床试验/NCT07196566
NCT07196566Enrolling By Invitation不适用

Double-Layer Closure of Oroantral Fistula Using Buccal Split-Thickness and Palatal Subepithelial Connective Tissue Flaps

Tanta University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
12
试验地点
1
主要终点
recurrence of fistula

研究概览

简要总结

A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.

详细描述

The proposed double-layer technique achieved high success rates in closing oroantral fistulas with minimal postoperative complications, reduced facial edema, and better preservation of vestibular depth compared to conventional techniques.

A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.

This technique demonstrated reliable, tension-free closure with excellent clinical outcomes, reduced postoperative facial edema, and preserved vestibular depth, supporting its potential as an effective and safe surgical option for managing oroantral fistulas.

The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients with oroantral fistula

排除标准

  • •patients with repeated oroantral fistula closure

研究组 & 干预措施

Double-Layer Closure of Oroantral Fistula Using Buccal and palatal Split-Thickness flap

Experimental

A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.

干预措施: Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft (Procedure)

结局指标

主要结局

recurrence of fistula

时间窗: one week -4 weeks

presence of oroantral fistula or not

vestibular height

时间窗: 1-3 months postoperatively

using periodontal prob

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed sobhie abdelhameed

Teaching assistant in oral and maxillofacial department, faculty pf dentistry, Tanta university

Tanta University

研究点 (1)

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