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

Gingival Recession Clinical Trial

Official title:

Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615092
• Other study ID #: CAAE: 0002.0.138.000.-11
• Status: Completed
• Phase: N/A
• Start date: January 30, 2011
• Est. completion date: July 13, 2018

Study information

• Verified date: August 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 13, 2018
• Est. primary completion date: October 5, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirao Preto - University of Sao Paulo	Ribeirão Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root coverage	Root coverage is measured by the difference between the gingival recession height at 6 months and baseline	6 months
Secondary	Keratinized tissue	The difference between keratinized tissue width and depth at 6 months and at baseline.	6months