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

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.

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.