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临床试验/NCT05987943
NCT05987943已完成不适用

Lecturer of Oral and Maxillofacial Surgery

Marwa Taha Ibrahim2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年3月21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
10
试验地点
2
主要终点
comparison of vestibular depth preoperatively and postoperatively

研究概览

简要总结

The aim of this study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

详细描述

Background: Oroantral fistula (OAF) is a pathological communication between the oral cavity and the maxillary sinus. A variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. To increase the success rates of OAF closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.

Purpose: The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

Patients & Methods: Ten patients with oroantral fistula will be included in this study. The patients will be examined and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation: It will include the collection of demographic data, medical status and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of fluid, infection and previous surgical closure attempts). Cone beam computed tomography (CBCT) scan will be performed to determine the size of the underlying bony defect.

Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will transected at the bone level, the pedicled deep periosteal layer will be dissected and turned over the fistula at the bone level and will be stabilized using sutures. The superficial layer will be returned to its original position and sutured.

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

入选标准

  • patients have oroantral fistula
  • clear maxillary sinus with no infection

排除标准

  • Patients suffering from any systemic diseases affect healing of soft tissue
  • patients have remaining roots or foreign body in sinus indicated for cald well luc opearation

结局指标

主要结局

comparison of vestibular depth preoperatively and postoperatively

时间窗: 1 month

the vestibular depth measured from gingival margin to bottom of vestibule.

visual analogue scale

时间窗: 1 month

0 representing no pain and 10 representing the highest level of pain

inflammation score scale

时间窗: 1 month

0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

次要结局

未报告次要终点

研究者

发起方
Marwa Taha Ibrahim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marwa Taha Ibrahim

principle investigator

Tanta University

研究点 (2)

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