Double-Layer Closure Technique Using Buccal and Palatal Flaps for Oroantral Fistula

NCT07196566 | Enrolling By Invitation DMC

• 1 other identifier: TantaOMS-OAF-DLC2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oroantral Fistula; Double Layer

Keywords

oroantral fistula; double layer closure; buccal flap; palatal flap; rotational palatal connective tissue flap

Outcome Measures

Primary Outcomes (2)

• recurrence of fistula

  presence of oroantral fistula or not

  one week -4 weeks

• vestibular height

  using periodontal prob

  1-3 months postoperatively

Study Arms (1)

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.

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

Interventions

Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft PROCEDURE

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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with oroantral fistula

You may not qualify if:

• patients with repeated oroantral fistula closure

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, 3111, Egypt

Location

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral Fistula; Mouth Diseases; Stomatognathic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• mohamed s abdelhameed, Asst lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant in oral and maxillofacial department, faculty pf dentistry, Tanta university

Model Details: All enrolled patients will undergo closure of chronic oroantral fistula using double-layer technique consist of split thickness buccal, palatal flap and rotational palatal underlaying connective tissue. this a single-arm, prospective clinical study.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 29, 2025
• Study Start: July 28, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 30, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

EG (1)