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Clinical Trials/NCT05987943
NCT05987943
Completed
Not Applicable

Lecturer of Oral and Maxillofacial Surgery

Marwa Taha Ibrahim1 site in 1 country10 target enrollmentMarch 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oroantral Fistula
Sponsor
Marwa Taha Ibrahim
Enrollment
10
Locations
1
Primary Endpoint
comparison of vestibular depth preoperatively and postoperatively
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2023
End Date
September 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Marwa Taha Ibrahim
Responsible Party
Sponsor Investigator
Principal Investigator

Marwa Taha Ibrahim

principle investigator

Tanta University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

comparison of vestibular depth preoperatively and postoperatively

Time Frame: 1 month

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

visual analogue scale

Time Frame: 1 month

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

inflammation score scale

Time Frame: 1 month

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

Study Sites (1)

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