ClinicalTrials.gg
CompletedNCT07433816Updated Mar 5, 2026

Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.

An interventional study of Tongue scraper and oral rinse treatment and Tongue scraper and aPDT (photodynamic therapy) in Halitosis, Halitoses and Fetor Oris, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Medical University of Silesia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2025, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The aim of this study is to compare the effectiveness of two methods of treating bad breath. Patients are enrolled in the study based on an objective test using the Oral Chroma Device, which measures the concentration of volatile sulfur compounds in exhaled air, which are responsible for bad breath. Before the test begins, a sample will also be taken from the tongue to determine the total number of microorganisms. Patients are then randomly assigned to two groups.

Control group: Cleaning the tongue with a tongue scraper and rinsing the mouth with an antiseptic mouthwash.

Intervention group: Cleaning the tongue with a tongue scraper and antibacterial laser therapy on the tongue.

Then, all study participants will undergo a procedure to clean tartar from all their teeth.

Questions to be answered by the study: Will there be a decrease in the concentration of volatile sulfur compounds in exhaled air after treatment? Will the treatment results obtained after laser therapy be better compared to the classic method of treating bad breath? Cleaning procedures within the tongue will be performed at the beginning, then repeated after one week, two weeks, and 3 months from the baseline.

After each stage, the concentration of substances in exhaled air that are responsible for bad breath will be measured. Samples will be taken from the tongue to determine the total number of microorganisms before the first tongue cleaning, and then after 2 weeks from the intervention.

02

Conditions studied

  • Halitosis
  • Halitoses
  • Fetor Oris
  • Oral Malodor

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03

In context

Halitosis

93 studies on the registry are indexed under Halitosis; 17 are open to participants now.

This study's enrollment of 48 is close to the median of 45 across 79 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 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

  • Participants diagnosed with halitosis based on an objective exhaled sulfhydryl (H2S) concentration of ≥ 112 ppb (1.5 ng/10 mL) determined by gas chromatography (Oral Chroma) and who signed an form previously approved by the Bioethics Committee were included in the study.

Exclusion criteria

Exclusion Criteria:

The study excluded patients with a history of the following diseases:

  • otolaryngological, i.e., chronic tonsillitis (presence of tonsil plugs), chronic sinusitis, head and neck cancer
  • gastrointestinal, i.e., Helicobacter Pylori infection, esophageal diverticulitis, pyloric sphincter insufficiency, severe gastroesophageal reflux disease
  • pulmonary, i.e., bronchitis, bronchiectasis, lung cancer - metabolic, i.e., diabetes, uremia, chronic renal failure, and liver disease as well as individuals taking pharmacotherapies such as antihistamines, , anticholinergics, antispasmodics, alcohol consumers, smokers, and those suffering from severe obesity.
  • on antibiotic or antifungals treatment up to 1 month before the survey,
  • pregnant Additinaly indyviduals with local abnormalities were excluded: using a removable device, implant and/or prosthesis, with carious lesions, during orthodontic and/or orthopedic treatment, with to the photosensitizer to be used.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Photodynamic therapy

    Procedure: Tongue scraper and aPDT (photodynamic therapy) · Procedure: full mouth scaling

  • Experimental
    Rinsing the mouth

    Procedure: Tongue scraper and oral rinse treatment · Procedure: full mouth scaling

Interventions

  • ProcedureTongue scraper and oral rinse treatment

    The procedure involves treating the tongue with a tongue scraper and rinsing the mouth with a chlorhexidine solution.

  • ProcedureTongue scraper and aPDT (photodynamic therapy)

    The procedure involves treatment with a tongue scraper and photodynamic therapy with toluidine blue using a diode laser.

  • Procedurefull mouth scaling

    removal of tartar deposits within both dental arches

06

What researchers measure

Primary outcomes

  1. Total number of microorganisms

    Swab samples were collected from the dorsum of the tongue (posterior third). The material collected from the tongue was inoculated separately onto the Rodac ConTact Test to determine the total number of microorganisms.

    Time frame: At the baseline, 2 weeks after the baseline

  2. Values of concentration of VSCs (volatile sulfur compounds) in exhaled air

    Values of concentration of VSCs above 112 ppb (1.5 ng/10 mL) were indicators of halitosis.

    Time frame: at the baseline, one week after the baseline, two weeks after the baseline,3 months after the baseline

07

Study locations

1 site
  • Department of Periodontology and Oral Mucosa Diseases
    Zabrze, Silesian Voivodeship 41-800, Poland
08

References and documents

Individual participant data

Plan to share: No

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 Jun 2025 to primary completion in Oct 2025, 4 months.

Of 35 non-industry interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 4 months is below that.

Counting every sponsor, half of 43 studies reached it within 10 months; a quarter within 3 and three quarters within 18.

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

Registered
Feb 19, 2026
First posted
Feb 25, 2026
StartActual
Jun 20, 2025
Primary completionActual
Oct 30, 2025
CompletionActual
Dec 30, 2025
Last update
Mar 5, 2026
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 Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07433816
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Jun 20, 2025
Primary completion
Oct 30, 2025
Completion
Dec 30, 2025
Last update
Mar 5, 2026

Oversight

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

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