A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

Not Applicable

Completed

• Conditions: Oroantral Fistula
• Interventions: Procedure: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

• Registration Number: NCT05987943
• Lead Sponsor: Marwa Taha Ibrahim

Brief Summary

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.

Detailed Description

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.

Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation and recurrences.

Study Timeline

• Study Start: 2023-03-21
• Primary Completion: 2023-04-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Study Completion: 2023-09-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. patients have oroantral fistula
2. clear maxillary sinus with no infection

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healing.recurrence of oroanral fistula	A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula	A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

Primary Outcome Measures

Name	Time	Method
comparison of vestibular depth preoperatively and postoperatively	1 month	the vestibular depth measured from gingival margin to bottom of vestibule.
visual analogue scale	1 month	0 representing no pain and 10 representing the highest level of pain
inflammation score scale	1 month	0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

Trial Locations

Locations (1)

Egypt; 🇪🇬 Tanta, Egypt