Ridge Preservation Comparing a Flap Versus Flapless Technique

Study Overview
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Brief Summary
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To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.

Detailed Description
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Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Official Title
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Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Procedure: Ridge Preservation


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 with a dental implant where at least one adjacent tooth is present Study subjects at least 18 years old Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board. Exclusion Criteria: Patients with debilitating systemic disease, or a disease affects the periodontium Have an allergy to any material or medication used in the study Require prophylactic antibiotics Previous head and neck radiation therapy Chemotherapy in the previous 12 months Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy Smoked more than one pack of cigarettes per day

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: Control<br>The flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal. | Procedure: Ridge Preservation<br>* Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.<br>|
| Experimental: Test<br>The test will be a flapless technique, no flap will be reflected. | Procedure: Ridge Preservation<br>* Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal Horizontal Ridge Width | Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper. | 4 months after surgery | 

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 after surgery |