Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies

February 24, 2023 updated by: Carla Andreotti Damante, University of Sao Paulo

Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.

The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.

Study Type

Interventional

Enrollment (Actual)

60

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)
  • Indication of root coverage by dentin hypersensitivity or esthetic.
  • Minimum palate thickness (1,5mm)
  • Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality
  • Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;

Exclusion Criteria:

  • Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
  • Smokers
  • Pregnancy
  • Diabetics
  • History of head and neck radiotherapy
  • Teeth with mobility
  • Malpositioned teeth
  • History of periodontal surgery at the area on the last 12 months
  • Patients with orthodontic therapy in progression

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Root surface treatment by scaling and root planing
Procedure: Control
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.
Other Names:
  • Scaling and root planing only
Experimental: antimicrobial photodynamic therapy
Root surface treatment by antimicrobial photodynamic therapy
Procedure: antimicrobial photodynamic therapy
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)
Active Comparator: Photobiomodulation
Treatment of the whole surgical site with laser
Procedure: Photobiomodulation
After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.
Other Names:
  • Low level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total root coverage
Time Frame: One year
Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized mucosa width
Time Frame: One year
Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width > 5mm
One year
Probing depth
Time Frame: One year
Probing depth measured with a periodontal probe in millimeters. The distance from gingival margin and the apical point of gingival pocket or sulcus. Ideal if <2mm.
One year
Clinical attachment level
Time Frame: One year
Clinical attachment level measured with a periodontal probe in millimeters. The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus. Ideal if <2mm.
One year
Dentin hypersensitivity
Time Frame: One year
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 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)

April 1, 2018

Primary Completion (Actual)

November 28, 2019

Study Completion (Actual)

November 28, 2019

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOBaPDTrecession

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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