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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Puros Dermis and Alloderm (both Allograft Tissue Matrix)
University of Alabama
Birmingham, Alabama, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
University of Rochester
Rochester, New York, United States
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.
Time frame: 12 months
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