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

Lecturer of Oral and Maxillofacial Surgery

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.

Study Overview

• Status: Completed
• Conditions: Oroantral Fistula
• Intervention / Treatment: Procedure: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: healing.recurrence of oroanral fistula; A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula	Procedure: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula; A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marwa Taha Ibrahim
• Investigators: Principal Investigator: marwa t Ibrahim, lecturer, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: oroantral fistula; A Pedicled Buccal Periosteal Flap
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Oral Fistula; Fistula; Oroantral Fistula
• Other Study ID Numbers: R-OS-9-22-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No