Effect of Collagen Membrane on Ridge Preservation (NCT07580495) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Collagen Membrane on Ridge Preservation
United States30 participantsStarted 2026-05-26
Plain-language summary
This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement.
Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans.
The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.
Who can participate
Age range
18 Years – 80 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 18-80
* Indicated for extraction of a single-rooted maxillary tooth
* ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions
* Presence of both adjacent teeth
* No interproximal bone loss
* ASA I-II health status
* Ability to comply with required procedures, including attending required number of clinic visits
Exclusion Criteria:
* Patients diagnosed with periodontitis adjacent to the area to be treated
* History of allergic reactions to local anesthetics or bone graft material (self-reported);
* Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
* Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
* Presence of active infectious diseases of any kind;
* History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
* Severe hematologic disorders (risk for hemorrhage)(self-reported);
* Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
* Any history of alcohol or drug abuse (self-reported);
* Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);
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.