Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant
Recruiting now · Not applicable
Conditions studied: Ridge Preservation, Allografts, Extraction, Tooth, Xenograft
In brief
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.
Key facts
- Study ID
- NCT06722482
- Run by
- University of Rochester
- People needed
- 50
- Starts
- 2023-11-27
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- patients with history of radiation of the head and neck
- patients with allergy to collagen, bacitracin and/or polymyxin B
- patients with religious or cultural beliefs that prohibit the use of either allograft or bovine graft material
- patients with physical and/or mental/cognitive disabilities (self-reported) or decisionally-impaired, not able to consent for themselves
- patients with untreated periodontitis
- patients with central/lateral incisors or canines requiring extraction and are adjacent to an edentulous area
- patients with central/lateral incisors or canines with buccal bone dehiscence >5mm
Where it is running
- Eastman Institute for Oral Health — Rochester, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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