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Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions

Primary Purpose

Gingival Recession, Gingival Diseases, Mouth Diseases

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
root coverage
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

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ages 18 to 50 years old bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm in height and less than 3mm of keratinized tissue in canine and pre-molar teeth

Exclusion Criteria:

diabetics pregnant women chronic use of medication periodontitis smokings

Sites / Locations

  • Gabriel F Bastos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

extended flap technique

tunnel technique

Arm Description

root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique

root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique

Outcomes

Primary Outcome Measures

Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months

Secondary Outcome Measures

Full Information

First Posted
May 13, 2016
Last Updated
May 19, 2016
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02774967
Brief Title
Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions
Official Title
Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The gold standard for the treatment of gingival recession, is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The acellular dermal matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of ADM 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 of utmost importance because the healing benefit and outcome. The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better cosmetic results 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 ADM as a graft. However , in one Quadrant partial flap will be held together with relaxing incisions through an incision intrasucular , ADM 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 a minimally invasive technique periosteal envelope above does not use relaxing incisions , preserves the buds will be held , as well as avoiding any scars, the graft will be used to ADM. The clinical parameters (probing depth, clinical attachment level, bleeding on probing index, height and width of the gingival retraction and height and thickness of keratinized gingiva) will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to surgical procedures. In addition, measurements of photographic gingival recession with the aid of software will be performed.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extended flap technique
Arm Type
Active Comparator
Arm Description
root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique
Arm Title
tunnel technique
Arm Type
Experimental
Arm Description
root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique
Intervention Type
Procedure
Intervention Name(s)
root coverage
Intervention Description
Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,
Primary Outcome Measure Information:
Title
Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 18 to 50 years old bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm in height and less than 3mm of keratinized tissue in canine and pre-molar teeth Exclusion Criteria: diabetics pregnant women chronic use of medication periodontitis smokings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arthur b novaes jr, PhD
Organizational Affiliation
FORP-USP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
gabriel f bastos, MSD Student
Organizational Affiliation
FORP-USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gabriel F Bastos
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14098561
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions

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