Effect of Collagen Membrane on Ridge Preservation

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Debora Dias
Study ID
NCT07580495
Status
Recruiting
Apply to this trial

Conditions

  • Alveolar Bone Loss
  • Dehiscence
  • Tooth Extraction

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Minimally Invasive tooth extraction — PROCEDURE
    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.
  • Alveolar ridge preservation with ABCC — DEVICE
    The extraction socket will be grafted with ABCC (SigmaGraft®).
  • Resorbable collagen membrane (InterCollagen® Guide) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 26, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group (bone graft only)
    Control group (bone graft only): The socket will be grafted with ABCC alone. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure.
  • Experimental: Test group (bone graft + collagen membrane)
    Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft). The socket will then be grafted with ABCC. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure.

Primary Outcome Measure

Horizontal dimensional changes (%) [ Time Frame: Baseline and 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive DentistryPittsburghPennsylvania15213
Debora R Dias, DDS, PhD
[email protected]
412-648-8595
Andrea Ravida, DDS, PhD
[email protected]
7347309678
Debora R Dias, DDS, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry· Pittsburgh, PA

Related Studies