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

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT06073704
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
14.5
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: antimicrobial photodynamic therapy (aPDT)
  • Procedure: Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.
Primary Purpose:
Treatment
Official Title:
Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity
Anticipated Study Start Date :
Oct 9, 2023
Anticipated Primary Completion Date :
Oct 23, 2024
Anticipated Study Completion Date :
Dec 23, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Probing depth [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.

    2. Clinical attachment level [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.

    Secondary Outcome Measures

    1. Changes on bleeding on probing [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.

    2. Differences in proteomics [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bauru School of Dentistry Bauru São Paulo Brazil 17012-901

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Carla Andreotti Damante, Associate professor, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT06073704
    Other Study ID Numbers:
    • Obesity and Periodontitis
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Carla Andreotti Damante, Associate professor, University of Sao Paulo
    periodontitis
    obesity
    Additional relevant MeSH terms:
    Periodontitis
    Obesity
    Anti-Infective Agents
    Anti-Bacterial Agents

    Study Results

    No Results Posted as of Oct 12, 2023