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

• ClinicalTrials.gov Identifier: NCT03615092
• Recruitment Status: Completed
• First Posted: August 3, 2018
• Last Update Posted: August 7, 2018
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Arthur Belem Novaes Jr, University of Sao Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gingival Recession	Procedure: Root coverage with extended flap technique and acelular dermal matrix	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Controlled Split-mouth clinical trial
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The clinical parameters were screened by one single examiner that was not aware of the procedures
• Primary Purpose: Treatment
• Official Title: Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial
• Actual Study Start Date: January 30, 2011
• Actual Primary Completion Date: October 5, 2011
• Actual Study Completion Date: July 13, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Procedure: 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.
Placebo Comparator: 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	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Keratinized tissue [ Time Frame: 6months ]
   The difference between keratinized tissue width and depth at 6 months and at baseline.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Brazil

School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, Sao Paulo, Brazil

Sponsors and Collaborators

University of Sao Paulo

More Information

• Responsible Party: Arthur Belem Novaes Jr, Phd, Ms, DDs. Chairman of Periodontolgy, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03615092
• Other Study ID Numbers: CAAE: 0002.0.138.000.-11
• First Posted: August 3, 2018
• Last Update Posted: August 7, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Arthur Belem Novaes Jr, University of Sao Paulo:

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

Additional relevant MeSH terms:

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