NCT07433816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 19, 2026

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    at the baseline, one week after the baseline, two weeks after the baseline,3 months after the baseline

Study Arms (2)

Photodynamic therapy

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

Rinsing the mouth

EXPERIMENTAL
Procedure: Tongue scraper and oral rinse treatmentProcedure: full mouth scaling

Interventions

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

Rinsing the mouth

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

Photodynamic therapy

removal of tartar deposits within both dental arches

Photodynamic therapyRinsing the mouth

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology and Oral Mucosa Diseases

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

MeSH Terms

Conditions

Halitosis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

June 20, 2025

Primary Completion

October 30, 2025

Study Completion

December 30, 2025

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations