Recruiting

ABCC & Collagen

Sponsor:

Debora Dias

Code:

NCT07580495

Conditions

Dehiscence

Tooth Extraction

Alveolar Bone Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Minimally Invasive tooth extraction

Alveolar ridge preservation with ABCC

Resorbable collagen membrane (InterCollagen® Guide)

Study Details

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.

Conditions

Dehiscence

Tooth Extraction

Alveolar Bone Loss

Study ID

NCT07580495

Start date

May 26, 2026

Status verified date

Jun, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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);

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Minimally Invasive tooth extraction

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

The extraction socket will be grafted with ABCC (SigmaGraft®).

Resorbable collagen membrane (InterCollagen® Guide)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Debora R Dias, DDS, PhD

4126488595deboradias@pitt.edu

Carla Sanchez, MS

4126241179cab28@pitt.edu

Locations

University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Debora R Dias, DDS, PhD

412-648-8595deboradias@pitt.edu

Andrea Ravida, DDS, PhD

7347309678andrearavida@pitt.edu

Principal Investigator:

Debora R Dias, DDS, PhD

More Information

Sponsor

Debora Dias

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Ridge preservation
  • Collagen membrane
  • Socket grafting
  • Buccal bone loss
  • Delayed implant placement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Debora Dias on 2026-06-04.