Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.

Detailed Description
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This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.

Official Title
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Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Puros® Dermis versus Alloderm®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, of any ethnicity, between 18 and 99 years of age. No known allergies to study material. Able to communicate with the investigator and read, understand, and sign the informed consent form. Maxillary incisor, canine, or premolar with at least one Miller's Class I or II gingival recession defects that are not adjacent to one another. Depth of the gingival recession defects of 2mm or greater. No gingival surgery within the past 12 months at the defect site. No prior antibiotic use within 3 months with less than 2 weeks durations. Ability to maintain good oral hygiene. Exclusion Criteria: Patients taking any medications known to cause gingival enlargement. Patients with unstable systemic diseases. Patients with compromised immune systems or unstable bleeding disorders. Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HIV, etc.). Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.). Patients taking steroid medications. Tobacco use or smoking within 1 year of screening visit (e.g. cigarettes, pipes, cigars, chew). Pregnant females or females attempting to get pregnant. Other conditions the investigator feels would inhibit from a good candidate for the study.

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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No

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: Group 1: Puros Dermis<br>Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. | Device: Puros® Dermis versus Alloderm®<br>* Puros Dermis and Alloderm (both Allograft Tissue Matrix)<br>* Other names: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM);|
| Active Comparator: Group 2: Alloderm<br>Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. | Device: Puros® Dermis versus Alloderm®<br>* Puros Dermis and Alloderm (both Allograft Tissue Matrix)<br>* Other names: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non -Inferiority of Dermis to Alloderm | Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exposed Root Surface or Tooth, Tooth Sensitivity Miller Class I, Miller Class II, Gingival Margin