Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant
Launched by UNIVERSITY OF ROCHESTER · Dec 2, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two types of bone graft materials used to help preserve bone after a front tooth is removed and before a dental implant is placed. The two materials being studied are freeze-dried bone allograft (FDBA), which comes from human donors, and collagen-enriched bovine xenograft (CEBX), which is made from cow tissue. Patients will be randomly assigned to receive one of these materials, and the study will look at how each affects the healing process and the overall success of the dental implant after about four months.
To participate, individuals must be at least 18 years old and need at least one front tooth extracted for an implant. They should be able to give informed consent and have healthy bone in the area where the tooth is being removed. However, certain people, such as smokers, those with uncontrolled diabetes, or women who are pregnant, cannot participate. Throughout the study, participants will have seven visits that coincide with their regular dental appointments, where their healing will be monitored, and their satisfaction with the treatment will be assessed. This research aims to find the best approach to ensure successful dental implants and improve patient experiences.
Gender
ALL
Eligibility criteria
- 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 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
About University Of Rochester
The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, New York, United States
Patients applied
Trial Officials
Elli Anna Kotsailidi, DDS, MS
Principal Investigator
Eastman Institute for Oral Health, University of Rochester
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported