Ridge Preservation Comparing a Polylactic Acid Membrane vs. an Acellular Dermal Matrix Membrane

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and resorbable membranes to determine if either provides a significant therapeutic advantage.

Detailed Description
-----------------
The control subjects will receive a bone graft in the extraction socket, plus an additional bone graft on the outside socket wall covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester. The test subjects will receive same type and technique of bone graft with a the acellular dermal matrix membrane to cover the bone graft. The membrane the patients receive will be randomly assigned using a coin toss: heads will be assigned to the test group while tails will be assigned for controls. The objective is to determine if at 4 months the width and height of the jaw bone and also the soft tissue thickness where the tooth was extracted has increased, decreased or remained the same. Also the amount of patients own newly formed bone will be determined by microscopic examination of a core of jaw bone that will be obtained from the site of implant placement immediately before the implant is placed (the implant is not considered part of the study).

Official Title
-----------------
Ridge Preservation Comparing the Clinical and Histologic Healing of a Bioabsorbable Membrane Made of Polylactic Acid and a Citric Acid Ester vs. an Acellular Dermal Matrix Allograft GBR

Conditions
-----------------
Ridge Preservation

Intervention / Treatment
-----------------
* Procedure: Acellular dermal matrix membrane
* Procedure: Polylactic acid membrane


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acellular dermal matrix membrane<br>An acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap. | Procedure: Acellular dermal matrix membrane<br>* The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive an intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft covered by an acellular dermal matrix, composed of human connective tissue matrix.<br>* Other names: Alloderm GBR;|
| Experimental: Polylactic acid membrane<br>A polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap. | Procedure: Polylactic acid membrane<br>* The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft, covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester<br>* Other names: Guidor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in crestal osseous width | Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper. | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent osseous tissue | A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space. | 4 months post-treatment |