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

May 19, 2016 updated by: Arthur Belem Novaes Jr, University of Sao Paulo

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Ribeirão Preto, SP, Brazil, 14098561
        • Gabriel F Bastos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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

Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,
Experimental: tunnel 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

Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: arthur b novaes jr, PhD, FORP-USP
  • Principal Investigator: gabriel f bastos, MSD Student, FORP-USP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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