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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881959
• Other study ID #: 07-800
• Status: Completed
• Phase: N/A
• First received: April 14, 2009
• Last updated: May 7, 2015
• Start date: August 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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, non-adjacent Miller's Class I or II gingival recession.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Puros® Dermis versus Alloderm®
Puros Dermis and Alloderm (both Allograft Tissue Matrix)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer, Inc.	Zimmer Dental

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No