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

March 3, 2026 updated by: Medical University of Silesia

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.

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 Overview

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photodynamic therapy
The procedure involves treatment with a tongue scraper and photodynamic therapy with toluidine blue using a diode laser.
removal of tartar deposits within both dental arches
Experimental: Rinsing the mouth
removal of tartar deposits within both dental arches
The procedure involves treating the tongue with a tongue scraper and rinsing the mouth with a chlorhexidine solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the baseline, 2 weeks after the baseline
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.
at the baseline, one week after the baseline, two weeks after the baseline,3 months after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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