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

Not Applicable

Recruiting

• Conditions: Periodontitis; Obesity
• Interventions: Procedure: Control; Procedure: antimicrobial photodynamic therapy (aPDT)

• Registration Number: NCT06073704
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-10-02
• Study Start: 2023-10-09
• Study First Posted: 2023-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Treatment of scaling and root planing.
Antimicrobial Photodynamic therapy adjunct to scaling and root planing	antimicrobial photodynamic therapy (aPDT)	Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, São Paulo, Brazil