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

NCT ID: NCT03615092

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-30
• Study Completion Date: 2018-07-13

Brief Summary

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Group

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.

Group Type: ACTIVE_COMPARATOR

Root coverage with extended flap technique and acelular dermal matrix

Intervention Type: 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.

Control Group

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

Group Type: PLACEBO_COMPARATOR

Root coverage with extended flap technique and acelular dermal matrix

Intervention Type: 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.

Interventions

Root coverage with extended flap technique and acelular dermal matrix

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Arthur Belem Novaes Jr

Phd, Ms, DDs. Chairman of Periodontolgy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAAE: 0002.0.138.000.-11

Identifier Type: -

Identifier Source: org_study_id