Trials / Completed
CompletedNCT01900964
Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane
Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable vs. a Collagen Membrane With an Intrasocket Mineralized Cancellous Allograft Plus a Facial Overlay Bovine Xenograft.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Louisville · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | PTFE membrane | The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure. |
| PROCEDURE | Collagen membrane | A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2013-07-17
- Last updated
- 2016-12-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01900964. Inclusion in this directory is not an endorsement.