Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity

February 9, 2024 updated by: Carla Andreotti Damante, University of Sao Paulo

Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity

The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

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
      • Bauru, São Paulo, Brazil, 17012-901
        • Recruiting
        • Bauru School of Dentistry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carla Damante, PhD
        • Sub-Investigator:
          • Andreia Pavani, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Obesity (grade II and III classified according to Body Mass Index)
  • Periodontitis stage II to IV
  • Presence of at least 20 teeth excluding 3rd molars.

Exclusion Criteria:

  • Smokers
  • Alcohol or drugs consumption
  • Kidney disorders
  • Pregnancy or lactation
  • Use of antibiotics at the last 30 days
  • Use of drugs that alter periodontal structures as phenytoin or ciclosporin
  • Periodontal treatment at the last 6 months

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
Experimental: Antimicrobial Photodynamic therapy adjunct to scaling and root planing
Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser
Procedure: antimicrobial photodynamic therapy (aPDT)
Scaling and root planing followed by antimicrobial photodynamic therapy
Other Names:
  • Photodynamic therapy
  • Photochemotherapy
Active Comparator: Control
Treatment of scaling and root planing.
Procedure: Control
Treatment of scaling and root planing
Other Names:
  • scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: Baseline, 1, 3 and 6 months
Changes in probing depth measured from the gingival margin to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.
Baseline, 1, 3 and 6 months
Clinical attachment level
Time Frame: Baseline, 1, 3 and 6 months
Changes in clinical attachment level measured from the cemento-enamel junction to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.
Baseline, 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in proteomics
Time Frame: baseline, 3 and 6 months
Changes in inflammatory proteins after treatment by proteomics assay. Presence or absence of proteins in gingival fluid are compared before and after treatment.
baseline, 3 and 6 months
Changes on bleeding on probing
Time Frame: Baseline, 1,3,and 6 months
Changes in percentage of sites with bleeding after probing. Six sites per tooth are examined and presence/absence of bleeding is recorded.
Baseline, 1,3,and 6 months

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)

October 9, 2023

Primary Completion (Estimated)

October 23, 2024

Study Completion (Estimated)

December 23, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity and Periodontitis

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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