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

NCT06073704 | Recruiting DMC

• 1 other identifier: Obesity and Periodontitis
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Periodontitis

Keywords

periodontitis; obesity

Outcome Measures

Primary Outcomes (2)

• Probing depth

  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

  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 Outcomes (2)

• Changes on bleeding on probing

  Baseline, 1,3,and 6 months

• Differences in proteomics

  baseline, 3 and 6 months

Study Arms (2)

Antimicrobial Photodynamic therapy adjunct to scaling and root planing

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

Treatment of scaling and root planing.

Procedure: Control

Interventions

antimicrobial photodynamic therapy (aPDT) PROCEDURE

Scaling and root planing followed by antimicrobial photodynamic therapy

Also known as: Photodynamic therapy, Photochemotherapy

Antimicrobial Photodynamic therapy adjunct to scaling and root planing

Control PROCEDURE

Treatment of scaling and root planing

Also known as: scaling and root planing

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

RECRUITING

Related Publications (2)

• Vohra F, Akram Z, Bukhari IA, Sheikh SA, Javed F. Short-term effects of adjunctive antimicrobial photodynamic therapy in obese patients with chronic periodontitis: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2018 Mar;21:10-15. doi: 10.1016/j.pdpdt.2017.10.022. Epub 2017 Oct 27.

  PMID: 29111391 BACKGROUND

• da Silva-Junior PGB, Abreu LG, Costa FO, Cota LOM, Esteves-Lima RP. The effect of antimicrobial photodynamic therapy adjunct to non-surgical periodontal therapy on the treatment of periodontitis in individuals with type 2 diabetes mellitus: A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2023 Jun;42:103573. doi: 10.1016/j.pdpdt.2023.103573. Epub 2023 Apr 14.

  PMID: 37062511 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Obesity

Interventions

Photochemotherapy; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)