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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Root coverage with extended flap technique and acelular dermal matrix
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Acellular dermal matrix graft, Clinical Trial, Root coverage, Noncarious cervical lesion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry of Ribeirao Preto - University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2018
Last Updated
August 4, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03615092
Brief Title
Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions
Official Title
Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2011 (Actual)
Primary Completion Date
October 5, 2011 (Actual)
Study Completion Date
July 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Acellular dermal matrix graft, Clinical Trial, Root coverage, Noncarious cervical lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Controlled Split-mouth clinical trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The clinical parameters were screened by one single examiner that was not aware of the procedures
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Root coverage with extended flap technique and acelular dermal matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Root coverage
Description
Root coverage is measured by the difference between the gingival recession height at 6 months and baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Keratinized tissue
Description
The difference between keratinized tissue width and depth at 6 months and at baseline.
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
School of Dentistry of Ribeirao Preto - University of Sao Paulo
City
Ribeirão Preto
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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