NCT00881959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 27, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

April 14, 2009

Results QC Date

May 7, 2015

Last Update Submit

May 7, 2015

Conditions

Gingival Recession

Keywords

exposed Root Surface or ToothTooth Sensitivity Miller Class IMiller Class IIGingival Margin

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (2)

Group 1: Puros Dermis

EXPERIMENTAL

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.

Device: Puros® Dermis versus Alloderm®

Group 2: Alloderm

ACTIVE COMPARATOR

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.

Device: Puros® Dermis versus Alloderm®

Interventions

Puros® Dermis versus Alloderm®DEVICE

Puros Dermis and Alloderm (both Allograft Tissue Matrix)

Also known as: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)
Group 1: Puros DermisGroup 2: Alloderm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-1078, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103-0009, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Results Point of Contact

Title
Hai Bo Wen
Organization
Zimmer Dental
haibo.wen@zimmer.com
760 929 4312

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

May 27, 2015

Results First Posted

May 27, 2015

Record last verified: 2015-05

Locations

US(4)