Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 80
- Locations
- 8
- Primary Endpoint
- Non -Inferiority of Dermis to Alloderm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Non -Inferiority of Dermis to Alloderm
Time Frame: 12 months
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.
Secondary Outcomes
No secondary outcomes reported