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Clinical Trials/NCT03251001
NCT03251001
Completed
Not Applicable

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

University of Sao Paulo1 site in 1 country25 target enrollmentFebruary 1, 1999
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ConditionsGingiva AtrophyGingivitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingiva Atrophy
Sponsor
University of Sao Paulo
Enrollment
25
Locations
1
Primary Endpoint
keratinized tissue width
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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)

Registry
clinicaltrials.gov
Start Date
February 1, 1999
End Date
December 20, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carla Andreotti Damante

Associate professor

University of Sao Paulo

Eligibility Criteria

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
  • •Pregnancy
  • •Intake of calcium channel blockers that cause gingival augmentation

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Attachment level(18 years)
  • Recession depth(18 years)
  • Probing depth(18 years)

Study Sites (1)

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