Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions

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

Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions

The aim of this study is to evaluate the additional effect of antimicrobial photodynamic therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone and porcine collagen membrane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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
      • Bauru, Brazil
        • Bauru School of Dentistry
    • 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars
  • Mandibular 1st and 2nd molars without caries, erosion or abrasion

Exclusion Criteria:

  • Smoking habit
  • Pregnancy
  • Use of antibiotics in the last six months
  • Periodontal treatment in the last six months
  • Endodontic lesion
  • Systemic diseases that impair wound healing

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
Decontamination of furcation defect with scaling and root planing only.
Procedure: Scaling and root planing
Furcation treatment by scaling and root planing
Experimental: Antimicrobial Photodynamic Therapy
Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.
Procedure: Scaling and root planing
Furcation treatment by scaling and root planing
Drug: Toluidine Blue O
Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
Other Names:
  • Antimicrobial photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal probing depth
Time Frame: one year
Measured with a periodontal probe (mm). Ideal if 0.
one year
Tomographic Bone filling
Time Frame: One year
Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: one year
Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
one year
Clinical Attachment Level
Time Frame: one year
Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
one year
Bleeding on probing
Time Frame: One year
Visual confirmation of bleeding after probing. Ideal if not bleeding.
One year

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Geistlich Pharma AG

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 2, 2017

Primary Completion (Actual)

December 22, 2018

Study Completion (Actual)

December 22, 2018

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 28, 2017

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BauruSchoolDentistryfurcation

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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