Clinical trial NCT00881959: Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
Official title: Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: exposed Root Surface or Tooth
Tooth Sensitivity Miller Class I
Miller Class II
Gingival Margin
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Zimmer Dental
First posted: 2009-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Non -Inferiority of Dermis to Alloderm
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: