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Completed

NCT Number: NCT03615092

Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions

Patients with high standards of oral hygiene frequently search for buccal gingival recession (GR) treatment due to cervical wear, root sensitivity and compromising aesthetics. The cervical lesion (NCCL) is commonly produced by improper toothbrushing techniques, sharing the same etiology of GR. Many different surgical approaches have been described. The association of a graft to the coronally advanced flap had demonstrated the best long-term outcome for root coverage. But, substitutes for the autogenous graft must be studied. Therefore, the aim of this clinical trial was to investigate the effectiveness of the acellular dermal matrix graft (ADMG) in root coverage associated with a previous restored cervical lesion or not.

Material and methods: Seventeen individuals with bilateral GR were included in the study. At one side, the GR must present a previously restored cervical lesion, as the test group (TG). The contralateral arch, must present GR with an intact root surface (CG). All patients were treated with the extended flap technique associated with the ADMG. All clinical parameters were assessed at baseline and 6-months postoperative.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • CEJ without significant damage;
  • localized bilateral RT112 gingival recession ≥3 mm in the same arch, in which one had a non-carious cervical lesion (NCCL) restored with composite and the opposite one was intact

Exclusion criteria

  • previous periodontal surgical treatment on the involved sites;
  • smokers
  • pregnants or lactating
  • compromised systemic health and contraindications for periodontal surgery

Treatment and study plan

Root coverage with extended flap technique and acelular dermal matrix

Procedure

At one side, the root coverage have been done with a extended flap technique and acellular dermal matrix and there was no cervical lesion. At the other side, the same technique was performed, but the gingival recession was associated with a noncarious cervical lesion.

Primary outcomes

  1. Root coverage

    Time frame: 6 months

    Root coverage is measured by the difference between the gingival recession height at 6 months and baseline

Secondary outcomes

  1. Keratinized tissue

    Time frame: 6months

    The difference between keratinized tissue width and depth at 6 months and at baseline.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Aug 7, 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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