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

This study has been completed.
Sponsor:
Collaborator:
Zimmer Dental
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00881959
First received: April 14, 2009
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Gingival Recession
 Device: Puros® Dermis versus Alloderm®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Descriptive statistics of patient demographics [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2009
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Puros Dermis
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.
 Device: Puros® Dermis versus Alloderm®
Puros Dermis and Alloderm (both Allograft Tissue Matrix)
Other Name: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)
Active Comparator: Group 2: Alloderm
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.
 Device: Puros® Dermis versus Alloderm®
Puros Dermis and Alloderm (both Allograft Tissue Matrix)
Other Name: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)

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, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881959

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-1078
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07103-0009
United States, New York
University of Rochester
Rochester, New York, United States, 14620
Sponsors and Collaborators
Zimmer, Inc.
Zimmer Dental
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00881959     History of Changes
Other Study ID Numbers: 07-800
Study First Received: April 14, 2009
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
exposed Root Surface or Tooth
Tooth Sensitivity Miller Class I
Miller Class II
Gingival Margin

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy

ClinicalTrials.gov processed this record on May 23, 2013