Ridge Preservation Comparing 2 Membranes

Study Overview
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Brief Summary
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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
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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 Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.

Conditions
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Alveolar Ridge Deficiency

Intervention / Treatment
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* Procedure: Non-resorbable membrane
* Procedure: Acellular dermal matrix


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 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 |
| --- | --- |
| Experimental: Acellular dermal matrix<br>A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane. | Procedure: Acellular dermal matrix<br>* The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.<br>* Other names: Acellular dermal matrix allograft, Alloderm;|
| Active Comparator: Non-resorbable membrane<br>A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane. | Procedure: Non-resorbable membrane<br>* The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.<br>* Other names: PTFE or Cytoplast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal ridge width | The width of the ridge at the crest will be measured with a digital caliper. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent vital bone | Percent vital bone at the graft site will be determined from a trephine core sample. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allograft, acellular dermal matrix, alveolar ridge