Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.
University of Rochester
Summary
The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material. The study aims to examine the following main questions: * Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing * Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated. The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as: * Demographic information * Clinical information from intraoral photographs * Radiographic information from cone beam computed tomography and periapical radiographs.
Description
The study will compare clinical, radiographic (dental cone beam computed tomography) and histologic outcomes upon tooth extraction and alveolar ridge preservation (ARP) as well as clinical, radiographic and patient-reported outcomes upon implant placement and crown fabrication at the same site. Both bone graft materials (FDBA and CEBX) are FDA approved and are widely available in the US market and are routinely used in everyday practices and within the university. * FDBA is produced by Community Blood Center (Community Tissue Services, Ohio, USA) (FEI: 3008808182). * CEBX is produced by Geis…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * patients able to provide informed consent * patients of 18 years of age or older at time of consent and enrollment * patients in need of at least one anterior tooth extraction and seeking dental implant replacement * bone on the buccal of the central/lateral incisors or canines planned for extraction that is either intact or has a dehiscence \</=5mm as determined radiographically through cone beam computed tomography (CBCT) Exclusion Criteria: * current smokers or tobacco-product users (self-reported) * uncontrolled diabetes (HbA1c≥7 in the last 3 months) * pregnant an…
Interventions
- DeviceFDBA
Twenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.
- DeviceCEBX
Twenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.
Location
- Eastman Institute for Oral HealthRochester, New York