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Completed

NCT Number: NCT06764342

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.

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Key information

Conditions

Periodontitis Halitosis Mouth Diseases Pathological Conditions, Signs and Symptoms Periodontal Diseases Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Minas Gerais, Dental School

Belo Horizonte, Minas Gerais, 31270-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

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.

Primary outcomes

  1. sulfur volatile compounds changes

    Time frame: baseline versus 21 and 45 days after treatment

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

Secondary outcomes

  1. Changes in periodontal probing depth

    Time frame: baseline versus 45 days after treatment

    Pre and pos-treatment changes in periodontal pocket depth (mm)

  2. Changes in organoleptic testing

    Time frame: Baseline versus 45 days after treatment

    Pre and post-treatment changes in organoleptic scores

  3. Changes in tongue total bacteria count

    Time frame: baseline versus 45 days after treatment

    Pre- and post-treatment changes in total bacteria counts from tongue dorsal samples

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Dec 22, 2025

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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