Surgical technique to close chronic oroantral fistulas
A Hinge Flap as an Additional Layer to Reinforce the Buccal Advancement Flap for Treating Chronic Oroantral Fistulae (COAF) in the Most Posterior Aspect of the Maxilla"
This study is testing a new surgical method to close chronic oroantral fistulas in the back of the mouth to see if it works better and reduces the chances of the problem coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qassim University Academic / other |
| Locations | 1 site (Buraidah, Al-Qassim Region) |
| Trial ID | NCT06066086 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel surgical approach to treat chronic oroantral fistulas (COAF) by using a hinge flap to reinforce a buccal advancement flap. The study aims to address the challenges associated with traditional flap techniques, particularly in the posterior maxilla, where complications such as compromised blood supply can lead to recurrence. By employing a double or triple-layer closure method, the trial seeks to enhance the success rate of the surgical closure and minimize the risk of recurrence. The study will include patients over 18 years old with COAF located in the posterior maxilla, who are medically fit for surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with chronic oroantral fistulas located at the most posterior area of the maxilla.
Not a fit: Patients with oroantral communications, those with sinus infections, or those whose fistulas resulted from tumor resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence rate of oroantral fistulas and improve surgical outcomes for patients.
How similar studies have performed: While traditional flap techniques have been used, this specific approach combining a hinge flap with a buccal advancement flap is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Chronic oroantral fistula at the most posterior area of the maxilla 2. Ages above 18 years 3. Patients who are medical free Exclusion Criteria: 1. Oroantral communications 2. Absence of sinus infection 3. Oroantral fistula which are resulted from tumor resections
Where this trial is running
Buraidah, Al-Qassim Region
- College of Dentistry, Qassim University — Buraidah, Al-Qassim Region, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Ghada A Khalifa, Professor
- Email: G.Khalifa@qudent.org
- Phone: 0096504840248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.