Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT06722482
- Status
- Recruiting
Conditions
- Allografts
- Extraction, Tooth
- Ridge Preservation
- Xenograft
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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 Dates
- Start date
- Nov 27, 2023
- Status verified
- Jan 2026
- Primary completion
- Nov 1, 2026
- Completion
- Nov 1, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: FDBA arm
- Active Comparator: CEBX arm
Primary Outcome Measure
Mean change in radiographic horizontal and vertical ridge dimensions [ Time Frame: baseline to 16 weeks after surgery ]
Central Contacts
- Elli Anna Kotsailidi, DDS, MS585-274-1146
- Nasser Assery, BDS, MS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eastman Institute for Oral Health | Rochester | New York | 14620 | Nasser Assery, BDS, MS Elli Anna Kotsailidi, DDS, MS (PRINCIPAL_INVESTIGATOR) Alexandra Tsigarida, DDS, MS (SUB_INVESTIGATOR) Nasser Assery, BDS, MS (SUB_INVESTIGATOR) Hongyue Cookie Wang, PhD (SUB_INVESTIGATOR) |