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Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

Primary Purpose

Gingival Recession, Xenograft Model, Gingival Recession, Generalized

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
tunnel technique for Root coverage with Porcine collagen Matrix
extended fla technique for Root coverage with Porcine collagen 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 Gingival recession, porcine collagen matrix, multiple gingival recessions, tunnel technique

Eligibility Criteria

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

Inclusion Criteria:

-bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height

Exclusion Criteria:

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

Sites / Locations

  • Marilia Bianchini Lemos ReisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test Group (tunnel technique)

Control Group (extended flap technique)

Arm Description

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique

Outcomes

Primary Outcome Measures

Root coverage (milimeters)
Root Coverage is measured by the difference between Gingival Recession Hight at baseline and 12 months

Secondary Outcome Measures

Keratinized tissue (milimeters)
Keratinized tissue is measured by its width and thickness.

Full Information

First Posted
January 17, 2018
Last Updated
August 1, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03619096
Brief Title
Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
Official Title
Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
July 6, 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome . The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Xenograft Model, Gingival Recession, Generalized
Keywords
Gingival recession, porcine collagen matrix, multiple gingival recessions, tunnel technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split Mouth clinical trial, comparing two different techniques. One side, the tunnel technique will be performed and on the other side, extended flap will be performed. Both surgical techniques will use Porcine Collagen Matrix.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participants and the outcomes Assessor are masked about the surgical technique that was performed. The surgical technique ir randomized in accordance with the arch side of each patient, so the investigator will open a envelope just before starting the incisions to know which technique will be performed.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group (tunnel technique)
Arm Type
Active Comparator
Arm Description
It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique
Arm Title
Control Group (extended flap technique)
Arm Type
Placebo Comparator
Arm Description
It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique
Intervention Type
Procedure
Intervention Name(s)
tunnel technique for Root coverage with Porcine collagen Matrix
Other Intervention Name(s)
mucograft matrix
Intervention Description
Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix
Intervention Type
Procedure
Intervention Name(s)
extended fla technique for Root coverage with Porcine collagen Matrix
Other Intervention Name(s)
mucograft matrix
Intervention Description
Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix
Primary Outcome Measure Information:
Title
Root coverage (milimeters)
Description
Root Coverage is measured by the difference between Gingival Recession Hight at baseline and 12 months
Time Frame
baseline, 6 and 12 motnhs
Secondary Outcome Measure Information:
Title
Keratinized tissue (milimeters)
Description
Keratinized tissue is measured by its width and thickness.
Time Frame
baseline, 6 and 12 months

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: -bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height Exclusion Criteria: diabetics pregnant women chronic use of medication periodontitis smokers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilia B Lemos Reis
Phone
+5516991482758
Email
marilia.bianchini.reis@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Belem Novaes JR
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marilia Bianchini Lemos Reis
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilia B Lemos Reis, MSD Student
Phone
+5516991482758
Email
marilia.bianchini.reis@usp.br
First Name & Middle Initial & Last Name & Degree
Arthur B Novaes Jr, Phd
First Name & Middle Initial & Last Name & Degree
Marilia B Lemos Reis, DDS

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

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