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Completed

NCT Number: NCT03251001

Acellular Dermal Matrix Allograft Versus Free Gingival Graft

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)

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Key information

Conditions

Gingiva Atrophy Gingival Diseases Gingival Recession Gingivitis Infections Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Procedure

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

Acellular Dermal Matrix

Device

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

Primary outcomes

  1. 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

  1. Probing depth

    Time frame: 18 years

    Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.

  2. Attachment level

    Time frame: 18 years

    Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.

  3. Recession depth

    Time frame: 18 years

    Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2017
Study completion
2017
First posted
Aug 16, 2017
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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