Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure (NCT07630701) | Clinical Trial Compass
CompletedNot Applicable
Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure
Syria24 participantsStarted 2024-09-15
Plain-language summary
This randomized controlled clinical study will evaluate the effectiveness of the inverted buccal periosteal flap in closing recent post-extraction oroantral communications and compare it with the conventional buccal advancement flap. The study will include 24 patients who develop an oroantral communication measuring 3-6 mm after non-surgical extraction of maxillary posterior teeth. Participants will be randomly allocated into two groups: the test group treated with the inverted buccal periosteal flap, and the control group treated with the buccal advancement flap. The primary outcome will be successful clinical closure of the communication, assessed by absence of oroantral fistula, nasal fluid leakage, and air leakage during the Valsalva test. Secondary outcomes will include postoperative pain, facial edema. Patients will be followed for up to 45 days after surgery.
Who can participate
Age range
24 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Presence of an oroantral communication (OAC) with a diameter between 3-7 mm.
. Communication resulting from extraction of posterior maxillary teeth (first molar, second molar, third molar, or second premolar).
. Recent perforation occurring no more than 48 hours prior to surgical intervention.
Exclusion criteria
. Presence of foreign bodies or residual tooth fragments within the maxillary sinus.
. Presence of systemic diseases that could impair wound healing (e.g., uncontrolled diabetes, immunosuppression).
. History of maxillary sinusitis prior to the perforation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful Closure of Oroantral Communication
Timeframe: 1 week, 15 days, and 45 days after surgery.