Back to results

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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Puros® Dermis versus Alloderm®

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring exposed Root Surface or Tooth, Tooth Sensitivity Miller Class I, Miller Class II, Gingival Margin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama
University of Michigan
University of Medicine and Dentistry of New Jersey
University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Puros Dermis

Group 2: Alloderm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00881959

First Posted

April 14, 2009

Last Updated

May 7, 2015

Sponsor

Zimmer Biomet

Collaborators

Zimmer Dental

1. Study Identification

Unique Protocol Identification Number

NCT00881959

Brief Title

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

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

Collaborators

Zimmer Dental

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

exposed Root Surface or Tooth, Tooth Sensitivity Miller Class I, Miller Class II, Gingival Margin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Puros Dermis

Arm Type

Experimental

Arm Description

Arm Title

Group 2: Alloderm

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Puros® Dermis versus Alloderm®

Other Intervention Name(s)

Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)

Intervention Description

Puros Dermis and Alloderm (both Allograft Tissue Matrix)

Primary Outcome Measure Information:

Title

Non -Inferiority of Dermis to Alloderm

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-1078

Country

United States

Facility Name

University of Medicine and Dentistry of New Jersey

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103-0009

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs