Effect of Collagen Membrane on Ridge Preservation

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

Interventions

PROCEDURE

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.

DEVICE

Alveolar ridge preservation with ABCC

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

DEVICE

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.

Sponsors & Collaborators

• SigmaGraft Inc.

  collaborator UNKNOWN

• Debora Dias

  lead OTHER

Principal Investigators

• Debora R Dias, DDS, PhD · University of Pittsburgh, Department of Periodontics and Preventive Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-10

Primary Completion

2027-10-31

Completion

2027-10-31

FDA Device

Yes

Countries

• United States

Study Locations