Clinical Efficacy
Conditions
Keywords
Regeneration, Bone regeneration, Grafting, Bone, Allograft, Xenograft
Brief summary
A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane when used for a post-extraction ridge preservation procedure to prevent the bone loss that typically occurs. The hypothesis is that there will be no difference in the clinical and histologic results between the two membranes.
Detailed description
Patient Selection 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
PROCEDUREPTFE membrane
The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.
PROCEDURECollagen membrane
A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.
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 (nonsteroidal anti-inflammatory drug) or steroid therapy. 10. Pregnant patients. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal ridge width | Time 4 months | The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent vital bone | Time 4 months | A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site. |
Countries
United States
Outcome results
None listed