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NCT Number: NCT06073704

Effects of Adjunct Antimicrobial Photodynamic Therapy in 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.

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Key information

Conditions

Periodontitis Body Weight Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Periodontal Diseases Signs and Symptoms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antimicrobial photodynamic therapy (aPDT)

Procedure

Scaling and root planing followed by antimicrobial photodynamic therapy

Other names: Photodynamic therapy, Photochemotherapy

Control

Procedure

Treatment of scaling and root planing

Other names: scaling and root planing

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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