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CompletedNCT06764342Updated Dec 22, 2025

Adjunctive Effect of Photodynamic Therapy on Halitosis

An interventional study of Full-mouth scaling combined with antimicrobial photodynamic therapy and full-mouth scaling in Periodontitis and Halitosis, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontitis
  • Halitosis

Keywords

  • halitosis
  • periodontitis
  • full-mouth disinfection
  • antimicrobial photodynamic therapy
  • real time polymerase chain reaction
  • bacteria
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's enrollment of 40 is close to the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 152 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Full-mouth scaling

    Full-mouth ultrasonic and manual periodontal instrumentation

    Procedure: full-mouth scaling

  • 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

Interventions

  • RadiationFull-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.

  • Procedurefull-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.

06

What researchers measure

Primary outcomes

  1. sulfur volatile compounds changes

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

    Time frame: baseline versus 21 and 45 days after treatment

Secondary outcomes

  1. Changes in periodontal probing depth

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

    Time frame: baseline versus 45 days after treatment

  2. Changes in organoleptic testing

    Pre and post-treatment changes in organoleptic scores

    Time frame: Baseline versus 45 days after treatment

  3. Changes in tongue total bacteria count

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

    Time frame: baseline versus 45 days after treatment

07

Study locations

1 site
  • Federal University of Minas Gerais, Dental School
    Belo Horizonte, Minas Gerais 31270-901, Brazil
08

References and documents

Individual participant data

Plan to share: No — Data will be analyzed by group and using numerical codes avoiding individual personal data identification. Data access will be protected by password.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Feb 2025, 1 month.

Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 1 month is below that.

Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2025
First posted
Jan 8, 2025
StartActual
Jan 8, 2025
Primary completionActual
Feb 22, 2025
CompletionActual
Jun 25, 2025
Last update
Dec 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06764342
Responsible party
Fernando O Costa (titular professor, Federal University of Minas Gerais) — Principal investigator
First posted
Jan 8, 2025
Start date
Jan 8, 2025
Primary completion
Feb 22, 2025
Completion
Jun 25, 2025
Last update
Dec 22, 2025

Study contacts

Fernando O Costa, doctorate
principal investigator · Federal University of Minas Gerais, Dental School

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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