NCT05505084

Alveolar Ridge Preservation Following Tooth Extraction.

Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method. In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge? The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.

Detailed description

The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months. The following products will be used during the study: * Collatape (Zimmer Dental)- approved by the FDA (class III) * Cytoplast (Osteogenics Biomedical)- cleared by the FDA * OssixPlus (Dantum Dental)- cleared by the FDA * Renovix-Plus (Salvin)- cleared by the FDA * BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking * PuroⓇ, Zimmer Dental)- cleared by the FDA * RegenerOssⓇ, Zimmer Dental) - cleared by the FDA During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following: * % viable of bone * % of connective tissue * % of residual graft material

Conditions

• Tooth Fractures
• Tooth Extraction Status Nos
• Caries

Interventions

Type	Name	Description
PROCEDURE	Tooth extraction and ridge preservation using different barrier mermbranes	The hopeless and unrestorable teeth are planned for extraction and implant placement.

Timeline

• Start date: 2022-08-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-08-17
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study