Acellular Dermal Matrix Allograft Versus Free Gingival Graft

March 8, 2018 updated by: Carla Andreotti Damante, University of Sao Paulo

Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial

The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Bauru, Sao Paulo, Brazil, 17012-901
        • Bauru School of Dentistry

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars
  • Miller Class I or II gingival recession
  • Absence of radiographic bone loss
  • Vital tooth or with adequate endodontic treatment
  • Root surfaces without caries
  • Good oral hygiene (plaque index < 20%)

Exclusion Criteria:

  • Allergic to penicillin
  • Presenting systemic disease that impede surgical procedure
  • Smokers
  • Pregnancy
  • Intake of calcium channel blockers that cause gingival augmentation

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: Control
Sites receiving a free gingival graft
Procedure: Control
Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva
Experimental: Device - Acellular dermal matrix
Sites receiving acellular dermal matrix
Device: Acellular Dermal Matrix
Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
Other Names:
  • allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
keratinized tissue width
Time Frame: 18 years
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm.
18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 18 years
Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
18 years
Attachment level
Time Frame: 18 years
Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
18 years
Recession depth
Time Frame: 18 years
Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.
18 years

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

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 (Actual)

February 1, 1999

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BauruSchoolDentistryADM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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