Osteotomy Clinical Trials

Clinical trials related to Osteotomy Procedure

Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
RECRUITING
Pittsburgh
Contact Information
Primary
Debora R Dias, DDS, PhD
deboradias@pitt.edu
4126488595
Backup
Carla Sanchez, MS
cab28@pitt.edu
4126241179
Time Frame
Start Date: 2026-05-26
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Debora Dias
Collaborators: SigmaGraft Inc.

This content was sourced from clinicaltrials.gov