Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

Study Overview
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Brief Summary
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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
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Patient Selection 30 patients will be selected that meet the following criteria: Inclusion Criteria 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. Healthy male or female who is at least 18 years old. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. Presence or history of osteonecrosis of jaws. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. Patients who have been treated with oral bisphosphonates for more than three years. Patients with an allergy to any material or medication used in the study. Patients who need prophylactic antibiotics. Previous head and neck radiation therapy. Chemotherapy in the previous 12 months. Patients on long term NSAID or steroid therapy. Pregnant patients.

Official Title
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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.

Conditions
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Clinical Efficacy

Intervention / Treatment
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* Procedure: PTFE membrane
* Procedure: Collagen membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Healthy male or female who is at least 18 years old. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. - Exclusion Criteria: Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. Presence or history of osteonecrosis of jaws. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. Patients who have been treated with oral bisphosphonates for more than three years. Patients with an allergy to any material or medication used in the study. Patients who need prophylactic antibiotics. Previous head and neck radiation therapy. Chemotherapy in the previous 12 months. Patients on long term NSAID (nonsteroidal anti-inflammatory drug) or steroid therapy. Pregnant patients. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTFE membrane<br>A non-resorbable PTFE (polytetrafluoroethylene) membrane will be used as a positive control treatment. | Procedure: PTFE membrane<br>* The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.<br>|
| Experimental: Collagen membrane<br>A resorbable collagen membrane will be used in the test group. | Procedure: Collagen membrane<br>* A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal ridge width | The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination. | Time 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent vital bone | A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site. | Time 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regeneration, Bone regeneration, Grafting, Bone, Allograft, Xenograft