Adjunctive Effect of Photodynamic Therapy on Halitosis

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Halitosis
• Intervention / Treatment: Procedure: full-mouth scaling; Radiation: Full-mouth scaling combined with antimicrobial photodynamic therapy

Detailed Description

The present study aims to evaluate halitosis in patients undergoing non-surgical periodontal therapy [(Full-mouth disinfection (FMD) combined with tongue scraping and antimicrobial photodynamic therapy (aPDT), and to assess its potential benefits for both periodontal and microbiological condition. A pilot study will be performed with participants who took part almost 10 years ago in the study NCT02368678. They will be invited by phone contact. In addition, new participants will be recruited by convenience in dental clinics from the Federal University of Minas Gerais until completion of 20 participants per group. Individuals with stage III periodontitis and halitosis (organoleptic method > 2), will be allocated into two periodontal treatment groups. Halitosis will be assessed using the organoleptic method and gas chromatography (OralChroma device) at three time points: before and after treatments. Microbiological samples will be collected before and after treatments from periodontal pockets and pooled samples from the tongue dorsum. These samples will be analyzed by using real-time PCR (q-PCR) aiming at detecting target bacterial species.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 31270-901
      • Federal University of Minas Gerais, Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Full-mouth scaling; Full-mouth ultrasonic and manual periodontal instrumentation	Procedure: full-mouth scaling; 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.
Experimental: Full-mouth scaling combined with antimicrobial photodynamic therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in periodontal probing depth	Pre and pos-treatment changes in periodontal pocket depth (mm)	baseline versus 45 days after treatment
Changes in organoleptic testing	Pre and post-treatment changes in organoleptic scores	Baseline versus 45 days after treatment
Changes in tongue total bacteria count	Pre- and post-treatment changes in total bacteria counts from tongue dorsal samples	baseline versus 45 days after treatment

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Fernando O Costa, doctorate, Federal University of Minas Gerais, Dental School

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): February 22, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: periodontitis; bacteria; halitosis; antimicrobial photodynamic therapy; full-mouth disinfection; real time polymerase chain reaction
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Periodontitis; Halitosis; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 30378613.5.0000.5149; NTC02368678 (Registry Identifier: clinicaltrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be analyzed by group and using numerical codes avoiding individual personal data identification. Data access will be protected by password.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No