Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.
Toluidin Blue Orto-Mediated Antimicrobial Photodynamic Therapy Or Lingual Scraper Associated With Periodontal Treatment In The Reduction Of Halitosis.
1 other identifier
interventional
48
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFirst Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedMarch 5, 2026
February 1, 2026
4 months
February 19, 2026
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
EXPERIMENTALRinsing the mouth
EXPERIMENTALInterventions
The procedure involves treating the tongue with a tongue scraper and rinsing the mouth with a chlorhexidine solution.
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
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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