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

NCT03615092 | Completed

• 1 other identifier: CAAE: 0002.0.138.000.-11
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Acellular dermal matrix graft; Clinical Trial; Root coverage; Noncarious cervical lesion

Outcome Measures

Primary Outcomes (1)

• Root coverage

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

  6 months

Secondary Outcomes (1)

• Keratinized tissue

  6months

Study Arms (2)

Test Group

ACTIVE COMPARATOR

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.

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

Control Group

PLACEBO COMPARATOR

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

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

Interventions

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.

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical parameters were screened by one single examiner that was not aware of the procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, Ms, DDs. Chairman of Periodontolgy

Model Details: Controlled Split-mouth clinical trial

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: January 30, 2011
• Primary Completion: October 5, 2011
• Study Completion: July 13, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)