Effect of Collagen Membrane on Ridge Preservation

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.

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);