Effect of Collagen Membrane on Ridge Preservation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDebora Dias

About this trial

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

Qualifiers

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

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Minimally Invasive tooth extraction
  • Alveolar ridge preservation with ABCC
  • Resorbable collagen membrane (InterCollagen® Guide)

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Debora Dias

Lead sponsor

University of Pittsburgh

Sponsor institution

SigmaGraft Inc.

Collaborator