Root Coverage Comparing an Allograft to a Bovine Xenograft

Study Overview
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Brief Summary
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Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials

Detailed Description
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Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.

Official Title
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Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Tunnel + AlloDerm
* Procedure: Tunnel + Novomatrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). The mucogingival defect must be on a non-molar tooth. Patients must be at least 18 years of age. Exclusion Criteria: Patients with debilitating systemic or diseases that significantly affect the periodontium. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline). Patients requiring antibiotic prophylaxis. Root surface restorations at the site of recession. No detectable CEJ Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces. Patients who are pregnant or lactating. Patients who use tobacco products (smoking or smokeless tobacco). Patients with alcohol abuse problems. Patients undergoing long-term steroid therapy. History of previous root coverage procedures, graft or GTR, on the test teeth. Patients who fail to complete the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Tunnel + AlloDerm®<br>A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®). | Procedure: Tunnel + AlloDerm<br>* A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).<br>* Other names: AlloDerm®;|
| Experimental: Tunnel + Novomatrix<br>A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix). | Procedure: Tunnel + Novomatrix<br>* A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).<br>* Other names: Novomatrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent root coverage | Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100. | 4 months |