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

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Root coverage with extended flap technique and acelular dermal matrix

• Registration Number: NCT03615092
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-30
• Primary Completion: 2011-10-05
• Study Completion: 2018-07-13
• Study First Submitted: 2018-07-30
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Last Update Submitted: 2018-08-04
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Root coverage with extended flap technique and acelular dermal matrix	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
Test Group	Root coverage with extended flap technique and acelular dermal matrix	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Keratinized tissue	6months	The difference between keratinized tissue width and depth at 6 months and at baseline.

Trial Locations

Locations (1)

School of Dentistry of Ribeirao Preto - University of Sao Paulo; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil