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

Completed · Not applicable

Conditions studied: Gingival Recession

In brief

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.

Key facts

Study ID

NCT00881959

Run by

Zimmer Biomet

People needed

80

Starts

2009-08-01

Expected to finish

2012-06-01

Last updated by the study team

2015-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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