- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433816
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.
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
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Silesian Voivodeship
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Zabrze, Silesian Voivodeship, Poland, 41-800
- Department of Periodontology and Oral Mucosa Diseases
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNW/NWN/0052/KB1/77/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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