Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions

November 11, 2011 updated by: Arthur Belem Novaes Jr, University of Sao Paulo

Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions

The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14040-904
        • Faculty of Dentistry of Ribeirão Preto USP

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
  • Main complaint aesthetic issues or dentine hypersensitivity
  • The patient must be a candidate for bilateral root coverage procedure
  • Patient shows sufficient plaque control (FMPS < 20%)
  • The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

  • Smokers
  • Systemic diseases
  • Pregnants or lactating
  • Periodontal disease
  • General contraindications for dental and/or surgical treatment are present
  • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
  • The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test and control
The test and control technique will be tested in a split-mouth design.
Procedure: Periodontal surgery to gingival recessions
Test and control technique to treat gingival recessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of root coverage
Time Frame: 6 months
Clinical parameters will be assessed after 6 months of surgical procedures.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized Tissue
Time Frame: 6 months
Clinical parameters will be assessed after 6 months of surgical procedures.
6 months

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Arthur B. Novaes Júnior, PhD, University of Sao Paulo
  • Principal Investigator: Lauro G. Ayub, MSD student, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 11, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lga030183

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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