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

Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Device: Puros® Dermis versus Alloderm®

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1078
      • University of Michigan
  • New Jersey
    • Newark, New Jersey, United States, 07103-0009
      • University of Medicine and Dentistry of New Jersey
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non -Inferiority of Dermis to Alloderm	Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.	12 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Zimmer Dental

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 14, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: exposed Root Surface or Tooth; Tooth Sensitivity Miller Class I; Miller Class II; Gingival Margin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 07-800