HalitosisNCT07433816
Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.
A study testing Tongue scraper and oral rinse treatment, Tongue scraper and aPDT (photodynamic therapy) and full mouth scaling in people with Halitosis and Halitoses, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Halitosis, Halitoses, Fetor Oris
- What is being tested?
- Tongue scraper and oral rinse treatment, Tongue scraper and aPDT (photodynamic therapy) and full mouth scaling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 informed consent form previously approved by the Bioethics Committee were included in the study.
Who cannot join
- 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, steroids, 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 hypersensitivity to the photosensitizer to be used.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Periodontology and Oral Mucosa Diseases
Zabrze, Silesian Voivodeship, 41-800
About this study
Official title: Toluidin Blue Orto-Mediated Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.
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.
Read more
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.
- Conditions
- Halitosis, Halitoses, Fetor Oris, Oral Malodor
- Being tested
- Tongue scraper and oral rinse treatment, Tongue scraper and aPDT (photodynamic therapy), full mouth scaling
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue scraper and oral rinse treatmentProcedure or surgery
The procedure involves treating the tongue with a tongue scraper and rinsing the mouth with a chlorhexidine solution.
Tongue scraper and aPDT (photodynamic therapy)Procedure or surgery
The procedure involves treatment with a tongue scraper and photodynamic therapy with toluidine blue using a diode laser.
full mouth scalingProcedure or surgery
removal of tartar deposits within both dental arches
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy | Experimental | Not described Receives: Procedure: Tongue scraper and aPDT (photodynamic therapy); Procedure: full mouth scaling |
| Rinsing the mouth | Experimental | Not described Receives: Procedure: Tongue scraper and oral rinse treatment; Procedure: full mouth scaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the baseline, 2 weeks after the baseline
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.
Measured: at the baseline, one week after the baseline, two weeks after the baseline,3 months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 Jun 2025
- Primary completion30 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 (control): cleaning the tongue with a tongue scraper and rinsing the mouth with an antiseptic mouthwash with chlorheksidine Group two (intervention): cleaning the tongue with a tongue scraper and aPDT (photodynamic therapy with toluidine blue) The intervention will be performed at the beginning, then repeated after 1 week, two weeks, and 3 months.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433816
- Sponsor's protocol ID
- BNW/NWN/0052/KB1/77/24
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toluidin Blue Orto-Mediated Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.
- ClinicalTrials.gov ID
- NCT07433816
- Acronym / sponsor ID
- BNW/NWN/0052/KB1/77/24
- Conditions
- Halitosis, Halitoses, Fetor Oris, Oral Malodor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Group 1 (control): cleaning the tongue with a tongue scraper and rinsing the mouth with an antiseptic mouthwash with chlorheksidine Group two (intervention): cleaning the tongue with a tongue scraper and aPDT (photodynamic therapy with toluidine blue) The intervention will be performed at the beginning, then repeated after 1 week, two weeks, and 3 months.
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy | Experimental | Procedure: Tongue scraper and aPDT (photodynamic therapy), Procedure: full mouth scaling |
| Rinsing the mouth | Experimental | Procedure: Tongue scraper and oral rinse treatment, Procedure: full mouth scaling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 informed consent form previously approved by the Bioethics Committee were included in the study.
Key exclusion criteria (6 listed)
- 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, steroids, 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 hypersensitivity to the photosensitizer to be used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue scraper and oral rinse treatmentThe procedure involves treating the tongue with a tongue scraper and rinsing the mouth with a chlorhexidine solution. | Procedure or surgery | Rinsing the mouth |
| Tongue scraper and aPDT (photodynamic therapy)The procedure involves treatment with a tongue scraper and photodynamic therapy with toluidine blue using a diode laser. | Procedure or surgery | Photodynamic therapy |
| full mouth scalingremoval of tartar deposits within both dental arches | Procedure or surgery | Photodynamic therapy, Rinsing the mouth |
Primary outcome
Total number of microorganisms
Time frame: At the baseline, 2 weeks after the baseline
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.
Values of concentration of VSCs (volatile sulfur compounds) in exhaled air
Time frame: at the baseline, one week after the baseline, two weeks after the baseline,3 months after the baseline
Values of concentration of VSCs above 112 ppb (1.5 ng/10 mL) were indicators of halitosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue scraper and oral rinse treatment, Tongue scraper and aPDT (photodynamic therapy) and full mouth scaling in people with Halitosis and Halitoses, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of microorganisms (time frame: At the baseline, 2 weeks after the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.