Adjunctive Effect of Photodynamic Therapy on Halitosis

NCT06764342 | Completed DMC

• 2 other identifiers: 30378613.5.0000.5149NTC02368678
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate bad breath in patients undergoing gingival treatment combined with tongue scraping and laser and to assess its potential benefits for both periodontal and microbiological condition. Firs patients will be selected among those who participated in a privies study. Additional patients will be also invited. They must have gum disease and bad breath. Treatments will be completed within 24 hours and oral samples will be collected with thin paper points. Bad breath will be evaluated by a professional and a specific gas machine.

Conditions

Periodontitis; Halitosis

Keywords

halitosis; periodontitis; full-mouth disinfection; antimicrobial photodynamic therapy; real time polymerase chain reaction; bacteria

Outcome Measures

Primary Outcomes (1)

• sulfur volatile compounds changes

  pre and post-treatment changes in levels (parts per billion) of CH3SH, a sulfur volatile compound

  baseline versus 21 and 45 days after treatment

Secondary Outcomes (3)

• Changes in periodontal probing depth

  baseline versus 45 days after treatment

• Changes in organoleptic testing

  Baseline versus 45 days after treatment

• Changes in tongue total bacteria count

  baseline versus 45 days after treatment

Study Arms (2)

Full-mouth scaling

ACTIVE COMPARATOR

Full-mouth ultrasonic and manual periodontal instrumentation

Procedure: full-mouth scaling

Full-mouth scaling combined with antimicrobial photodynamic therapy

EXPERIMENTAL

Full-mouth ultrasonic and manual periodontal instrumentation combined with antimicrobial photodynamic therapy applied to tongue dorsum and periodontal pockets

Radiation: Full-mouth scaling combined with antimicrobial photodynamic therapy

Interventions

full-mouth scaling PROCEDURE

Full-mouth scaling within 24 hours, divided into two sessions of ultrasonic instrumentation followed by manual supra- and subgingival scaling and root planing. Tongue cleaning was performed with a tongue scraper.

Full-mouth scaling

Full-mouth scaling combined with antimicrobial photodynamic therapy RADIATION

After full-mouth scaling procedures antimicrobial photodynamic therapy was carried out using a laser-activated disinfection device with a red laser emission (wavelength: 630 nm, irradiance: 2000-4000 mW/cm², spot size at the probe tip: 8 mm diameter) and high-viscosity methylene blue gel (0.1 mg/mL) which was applied at six spots on the tongue dorsum. Antimicrobial photodynamic therapy was also applied iIn sites with altered periodontal pocket depth (≥ 4mm). The dye remained in the pockets for 10 minutes to ensure full absorption and its excess was rinsed with sterile saline after laser exposure.

Full-mouth scaling combined with antimicrobial photodynamic therapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported halitosis;
• organoleptic score \>2;
• stage III periodontitis;
• at least 14 teeth.

You may not qualify if:

• smokers or former smokers;
• individuals diagnosed with diabetes and/or immune diseases;
• pregnant or lactating women;
• individuals with removable partial dentures and/or fixed or removable orthodontic appliances;
• systemic use of antibiotics or anti-inflammatory drugs in the last three months; - individuals who required prophylactic antibiotics for periodontal exams and treatments;
• individuals who regularly used or had used any type of mouthwash in the past three months;
• individuals who underwent periodontal treatment in the six months prior to the study.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais, Dental School

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Halitosis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando O Costa, doctorate

  Federal University of Minas Gerais, Dental School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: titular professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: January 8, 2025
• Primary Completion: February 22, 2025
• Study Completion: June 25, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)