N/A
N=80
Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
Gingival Recession
Bottom Line
View on ClinicalTrials.gov: NCT00881959 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Non -Inferiority of Dermis to Alloderm — 2.06; 2.00 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Puros® Dermis versus Alloderm® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non -Inferiority of Dermis to Alloderm |
2.06; 2.00 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00881959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.