Acute Oroantral Communication Closure: Resorbable Collagen Membrane vs. Buccal Advancement Flap O… (NCT07476664) | Clinical Trial Compass
CompletedNot Applicable
Acute Oroantral Communication Closure: Resorbable Collagen Membrane vs. Buccal Advancement Flap Outcomes
Poland24 participantsStarted 2021-05-01
Plain-language summary
Oroantral communication (OAC) is an abnormal opening between the oral cavity and the maxillary sinus that may occur after extraction of posterior maxillary teeth. If not treated promptly, it can lead to sinus contamination, chronic infection, and development of an oroantral fistula requiring more complex surgical management. The standard surgical treatment is closure with a buccal advancement flap (Rehrmann technique). However, this method may reduce vestibular depth, displace the mucogingival junction, and decrease the width of keratinized gingiva.
This prospective clinical study compares two surgical approaches for closure of acute OAC diagnosed within 24 hours after tooth extraction: placement of a resorbable collagen membrane beneath the mucosa versus the conventional buccal advancement flap. Clinical and radiographic parameters related to soft tissue architecture, postoperative recovery, and bone healing are evaluated during a 90-day follow-up period.
Who can participate
Age range
18 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:
* Adults aged 18 years or older
* Acute oroantral communication diagnosed within 24 hours after extraction of a maxillary posterior tooth
* General health status permitting outpatient dental surgery
* Indication for single-tooth extraction in the posterior maxilla
* Systemic conditions not contraindicating minor oral surgery
* Ability and willingness to attend scheduled follow-up visits
* Provision of written informed consent
Exclusion Criteria:
* Oroantral communication present for more than 24 hours
* Chronic inflammatory disease of the maxillary sinus
* History of head and neck neoplastic disease or its treatment
* Pregnancy
* Systemic diseases preventing outpatient surgical treatment
* Blood disorders or coagulation abnormalities
* Ongoing anticoagulant therapy
* Immunosuppressive therapy
* Age under 18 years
* History of multiple previous surgical procedures in the study area
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
Change in vestibular depth from baseline to 90 days
Timeframe: Baseline (day 0) to 90 days postoperatively