Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
Completed · Not applicable
Conditions studied: Alveolar Bone Loss
In brief
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Key facts
- Study ID
- NCT02515058
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 44
- Starts
- 2015-09-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2018-01-23
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
- Patients will are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Smokers who smoke >10 cigarettes per day
- Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
- Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants
Where it is running
- UT Health Science Center at San Antonio, School of Dentistry — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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