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Completed

NCT Number: NCT07433816

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.

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.

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Key information

Conditions

Halitosis Fetor Oris Halitoses Oral Malodor Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral Mucosa Diseases

Zabrze, Silesian Voivodeship, 41-800, Poland

Who can participate

Healthy volunteers accepted: No

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

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 informed consent form previously approved by the Bioethics Committee were included in the study.

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, 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.

Treatment and study plan

Tongue scraper and oral rinse treatment

Procedure

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

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

full mouth scaling

Procedure

removal of tartar deposits within both dental arches

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Toluidin Blue Orto-Mediated Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Mar 5, 2026

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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