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.
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)
current smokers or tobacco-product users (self-reported)
uncontrolled diabetes (HbA1c≥7 in the last 3 months)
pregnant and/or lactating females (self-reported)
patients on immunosuppressants, steroids, bisphosphonates or other medications that have been related to Medication-Related Osteonecrosis of the Jaw (MRONJ) as described by the American Association of Oral Maxillofacial Surgeons (AAOMS) 2014 update
Parallel
FDBA
DeviceTwenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.
CEBX
DeviceTwenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.
Mean change in radiographic horizontal and vertical ridge dimensions
Linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes will be measured and compared between groups after 16 weeks of healing.
Mean change in alveolar ridge contour
Alveolar ridge contour changes as they appear on intraoral optical scans will be measured and compared between groups.
Mean change in alveolar ridge contour
Alveolar ridge contour changes as they appear on intraoral optical scans will be measured and compared between groups.
Mean change in alveolar ridge contour
Alveolar ridge contour changes as they appear on intraoral optical scans will be measured and compared between groups.
Number of implants/participants with an implant placed on a prosthetically driven position
Feasibility of prosthetically driven implant placement will be assessed with an implant planning software on the cone beam computed tomography obtained at 16 weeks after the ARP, and compared between groups
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University of Rochester
Lead sponsor
Implant Dentistry Research & Education Foundation (IDREF)
Collaborator
