Effect of Collagen Membrane on Ridge Preservation

Debora Dias

Status: Enrolling

Conditions: Tooth Extraction; Dehiscence; Alveolar Bone Loss

Treatments: Device: Resorbable collagen membrane (InterCollagen® Guide); Procedure: Minimally Invasive tooth extraction; Device: Alveolar ridge preservation with ABCC

Study type: Interventional

Funder types: Other

Identifiers

NCT07580495

STUDY25080006

Details and patient eligibility

About

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.

Full description

This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants.

Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it.

Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement.

During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing.

The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Control group (bone graft only)

Active Comparator group

Description:

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.

Treatment:

Device: Alveolar ridge preservation with ABCC

Procedure: Minimally Invasive tooth extraction

Test group (bone graft + collagen membrane)

Experimental group

Description:

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.

Treatment:

Device: Alveolar ridge preservation with ABCC

Procedure: Minimally Invasive tooth extraction

Device: Resorbable collagen membrane (InterCollagen® Guide)