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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular dermal matrix membrane | Active Comparator | An acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap. |
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| Polylactic acid membrane | Experimental | A polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular dermal matrix membrane | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Greenwell, DMD, MSD | University of Louisville School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graduate Periodontics Clinic, School of Dentistry, University of Louisville | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| C105021 | Guidor |
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| Polylactic acid membrane | Procedure | 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 |
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