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

U

University of Sao Paulo

Status

Completed

Conditions

Gingival Recession

Treatments

Procedure: Root coverage with extended flap technique and acelular dermal matrix

Study type

Interventional

Funder types

Other

Identifiers

NCT03615092
CAAE: 0002.0.138.000.-11

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

17 participants in 2 patient groups, including a placebo group

Test Group
Active Comparator group
Description:
Active Comparator: gingival recession with a previous restored cervical lesion the aim of this study is to compare if the acellular dermal matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions with non carious cervical lesions.
Treatment:
Procedure: Root coverage with extended flap technique and acelular dermal matrix
Control Group
Placebo Comparator group
Description:
the aim of this study is to compare if the acellular dermal matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions with non carious cervical lesions. The control group had no cervical lesion, and was treated with the same technique as the acelular dermal matrix graft
Treatment:
Procedure: Root coverage with extended flap technique and acelular dermal matrix

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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