Effect of Collagen Membrane on Ridge Preservation
Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial
Debora Dias
30 participants
May 26, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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);
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Interventions
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
The extraction socket will be grafted with ABCC (SigmaGraft®).
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07580495