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

Zimmer Biomet

Status: Completed

Conditions: Gingival Recession

Treatments: Device: Puros® Dermis versus Alloderm®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881959

07-800

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group 1: Puros Dermis

Experimental group

Description:

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.

Treatment:

Device: Puros® Dermis versus Alloderm®

Group 2: Alloderm

Active Comparator group

Description:

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.

Treatment:

Device: Puros® Dermis versus Alloderm®