NCT07580495 Effect of Collagen Membrane on Ridge Preservation
| NCT ID | NCT07580495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Debora Dias |
| Condition | Dehiscence |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-05-26 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Adults aged 18-80 * Indicated for extraction of a single-rooted maxillary tooth * ≥ 30% 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);
Contact & Investigator
Debora R Dias, DDS, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh, Department of Periodontics and Preventive Dentistry
Frequently Asked Questions
Who can join the NCT07580495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dehiscence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07580495 currently recruiting?
Yes, NCT07580495 is actively recruiting participants. Contact the research team at deboradias@pitt.edu for enrollment information.
Where is the NCT07580495 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07580495 clinical trial?
NCT07580495 is sponsored by Debora Dias. The principal investigator is Debora R Dias, DDS, PhD at University of Pittsburgh, Department of Periodontics and Preventive Dentistry. The trial plans to enroll 30 participants.