Status:
COMPLETED
Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Zimmer Dental
Conditions:
Gingival Recession
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, ...
Detailed 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, t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00881959
Start Date
August 1 2009
End Date
June 1 2012
Last Update
May 27 2015
Active Locations (4)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of Michigan
Ann Arbor, Michigan, United States, 48109-1078
3
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07103-0009
4
University of Rochester
Rochester, New York, United States, 14620