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NCT Number: NCT07196566

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Tanta university

Tanta, 3111, Egypt

About this study

The proposed double-layer technique achieved high success rates in closing oroantral fistulas with minimal postoperative complications, reduced facial edema, and better preservation of vestibular depth compared to conventional techniques.

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.

This technique demonstrated reliable, tension-free closure with excellent clinical outcomes, reduced postoperative facial edema, and preserved vestibular depth, supporting its potential as an effective and safe surgical option for managing oroantral fistulas.

The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with oroantral fistula

Exclusion criteria

  • patients with repeated oroantral fistula closure

Treatment and study plan

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.

Primary outcomes

  1. recurrence of fistula

    Time frame: one week -4 weeks

    presence of oroantral fistula or not

  2. vestibular height

    Time frame: 1-3 months postoperatively

    using periodontal prob

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Double-Layer Closure of Oroantral Fistula Using Buccal Split-Thickness and Palatal Subepithelial Connective Tissue Flaps

Acronym: OAF-DLC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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