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Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
root coverage comparing two techniques
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 root coverage, gingival recession, periodontal surgery

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 25 to 50 years old
  • bilateral gingival recession type Miller class I or II
  • with 3 mm in height and less than 3mm of keratinized tissue
  • non-molar teeth

Exclusion Criteria:

  • diabetics
  • pregnant women
  • chronic use of medication
  • periodontitis

Sites / Locations

  • School of dentistry of Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

coronal advanced technique

extended flap technique

Arm Description

root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique)

root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique)

Outcomes

Primary Outcome Measures

Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months
At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2014
Last Updated
May 1, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02129504
Brief Title
Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix
Official Title
Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
root coverage, gingival recession, periodontal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
coronal advanced technique
Arm Type
Experimental
Arm Description
root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique)
Arm Title
extended flap technique
Arm Type
Experimental
Arm Description
root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique)
Intervention Type
Device
Intervention Name(s)
root coverage comparing two techniques
Other Intervention Name(s)
Mucograft, porcine collagen matrix, extended flap technique, coronal advanced flap technique
Intervention Description
The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.
Primary Outcome Measure Information:
Title
Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months
Description
At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter.
Time Frame
Change from Baseline at 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ages 25 to 50 years old bilateral gingival recession type Miller class I or II with 3 mm in height and less than 3mm of keratinized tissue non-molar teeth Exclusion Criteria: diabetics pregnant women chronic use of medication periodontitis
Facility Information:
Facility Name
School of dentistry of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20350159
Citation
McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.
Results Reference
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Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

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