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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Puros® Dermis versus Alloderm®

Intervention Type DEVICE

Puros Dermis and Alloderm (both Allograft Tissue Matrix)

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.

Group Type ACTIVE_COMPARATOR

Puros® Dermis versus Alloderm®

Intervention Type DEVICE

Puros Dermis and Alloderm (both Allograft Tissue Matrix)

Interventions

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Puros® Dermis versus Alloderm®

Puros Dermis and Alloderm (both Allograft Tissue Matrix)

Intervention Type DEVICE

Other Intervention Names

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Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No