Acellular Dermal Matrix Allograft Versus Free Gingival Graft

NCT ID: NCT03251001

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-01

Study Completion Date

2017-12-20

Brief Summary

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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)

Detailed Description

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Conditions

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Gingiva Atrophy Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth design. One side of mouth was test group, other side was control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.

Study Groups

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Control

Sites receiving a free gingival graft

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva

Device - Acellular dermal matrix

Sites receiving acellular dermal matrix

Group Type EXPERIMENTAL

Acellular Dermal Matrix

Intervention Type DEVICE

Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate

Interventions

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Control

Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Other Intervention Names

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allograft

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carla Andreotti Damante

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bauru School of Dentistry

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.

Reference Type BACKGROUND
PMID: 15974840 (View on PubMed)

Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.

Reference Type BACKGROUND
PMID: 26681852 (View on PubMed)

Other Identifiers

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BauruSchoolDentistryADM

Identifier Type: -

Identifier Source: org_study_id

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