Socket Healing Clinical Trial
Official title:
Ridge Preservation Comparing the Clinical and Histologic Healing of an Intrasocket Mineralized Cancellous Allograft vs. an Intrasocket Mineralized Cancellous Allograft Plus a Facial Overlay Graft Using Bovine Xenograft With a Bioabsorbable Barrier Membrane
The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth. 2. Healthy person that is at least 18 years old. 3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: 1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. 2. Molar teeth. 3. Presence of or history of osteonecrosis of the jaws. 4. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration. 5. Patients who have been treated with oral bisphosphonates for more than three years. 6. Pregnant women due to the possibility of miscarriage. 7. Patients with an allergy to any material or medication used in the study. 8. Patients who need prophylactic antibiotics. 9. Previous head and neck radiation therapy. 10. Chemotherapy in the previous 12 months. 11. Patients on long term NSAID or steroid therapy. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Graduate Periodontics Clinic, School of Dentistry, University of Louisville | Louisville | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| University of Louisville |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Horizontal ridge dimension | WIll be measured with a digital caliper | 4 months | No |
| Secondary | Histologic healing of the osseous graft | Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages | 4 months | No |