Alveolar Ridge Deficiency
Conditions
Keywords
allograft, acellular dermal matrix, alveolar ridge
Brief summary
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.
Detailed description
30 patients will be selected that meet the following criteria: 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 male or female who 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. Presence or history of osteonecrosis of jaws. 3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. 4. Patients who have been treated with oral bisphosphonates for more than three years. 5. Patients with an allergy to any material or medication used in the study. 6. Patients who need prophylactic antibiotics. 7. Previous head and neck radiation therapy. 8. Chemotherapy in the previous 12 months. 9. Patients on long term NSAID or steroid therapy. 10. Pregnant patients.
Interventions
PROCEDURENon-resorbable membrane
The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.
PROCEDUREAcellular dermal matrix
The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 male or female who 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. Presence or history of osteonecrosis of jaws. 3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. 4. Patients who have been treated with oral bisphosphonates for more than three years. 5. Patients with an allergy to any material or medication used in the study. 6. Patients who need prophylactic antibiotics. 7. Previous head and neck radiation therapy. 8. Chemotherapy in the previous 12 months. 9. Patients on long term NSAID or steroid therapy. 10. Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal ridge width | 4 months | The width of the ridge at the crest will be measured with a digital caliper. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent vital bone | 4 months | Percent vital bone at the graft site will be determined from a trephine core sample. |
Countries
United States
Outcome results
None listed