Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

March 23, 2017 updated by: Carla Andreotti Damante, University of Sao Paulo

Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial

The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.

Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.

Study Type

Interventional

Enrollment (Actual)

14

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
    • Sao Paulo
      • Bauru, Sao Paulo, Brazil, 17012-901
        • Bauru School of Dentistry

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
  • Indication of root coverage by dentin hypersensitivity or esthetic

Exclusion Criteria:

  • Smokers
  • Pregnancy
  • Systemic medication use that could impair wound healing or surgery procedure
  • Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Root treatment with scaling and root planing.
Procedure: Control
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing
EXPERIMENTAL: Citric acid plus tetracycline
Root treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s.
Procedure: citric acid plus tetracycline
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline
EXPERIMENTAL: Antimicrobial photodynamic therapy
Antimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s)
Procedure: antimicrobial photodynamic therapy
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total root coverage measured with a periodontal probe in mm
Time Frame: one year
Distance from cemento-enamel junction to gingival margin = 0 mm
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized mucosa width measured with a periodontal probe in mm
Time Frame: one year
Ideal if keratinized mucosa width > 5mm
one year
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale
Time Frame: one year
Ideal if scale = 0
one year

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

March 10, 2014

Primary Completion (ACTUAL)

February 10, 2017

Study Completion (ACTUAL)

March 10, 2017

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (ACTUAL)

March 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BauruSchoolDentistryPDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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