Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation

May 24, 2014 updated by: Michael K McGuire, Perio Health Professionals, PLLC

A Randomized, Controlled Clinical Trial to Evaluate a Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation

A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (< 2mm) KT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least two non-adjacent teeth in contralateral quadrants of the same jaw with < 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites.

    • Root coverage is not desired at the time of grafting.
    • Females of childbearing potential must have a documented negative urine pregnancy test.
    • Read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
    • Able and willing to follow study procedures and instructions.
    • Multi-rooted teeth may be treated but will not be included as study teeth

Exclusion Criteria:

  • Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility.

    • Any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
    • Presence of acute infectious lesions in the areas intended for surgery.
    • History of any tobacco use within the last six months.
    • Taking intramuscular or intravenous bisphosphonates.
    • Known hypersensitivity to collagen products, and/or allergy to iodine or shellfish.
    • Participating in other clinical studies involving therapeutic intervention (either medical or dental).
    • Previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site.
    • Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study.
    • Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: xenogeneic collagen matrix
Xenogeneic collagen matrix device placed on treatment wound bed site
Device: Xenogeneic Collagen Matrix
A type I and III porcine collagen matrix, as cleared by FDA (K012423)
Active Comparator: Free Gingival Graft
Traditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed
Device: Free Gingival Graft
Autogenous, full-thickness soft tissue graft harvested from patient's palate.
Other Names:
  • Free Autogenous Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized Tissue Width
Time Frame: 6 months
Change in Keratinized Tissue width
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perio Health Professionals, PLLC

Investigators

  • Principal Investigator: Michael K McGuire, DDS, Perio Health Professionals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

May 24, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13562-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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