Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-02
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Probiotic
Probiotic treatment
Daily intake of a lozenge containing the probiotic strain S. salivarius M18.
Placebo
Placebo
Placebo
Interventions
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Probiotic treatment
Daily intake of a lozenge containing the probiotic strain S. salivarius M18.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Able to read and receive a copy of the signed informed consent form.
3. Have at least 20 natural teeth.
4. Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw \> 6 months.
5. An average plaque score of \> 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.
Exclusion Criteria
2. History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
3. History of allergies to milk proteins.
4. History of allergies towards probiotics.
5. Self-reported as pregnant or nursing.
6. Self-reported serious medical conditions.
7. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
8. Acute sinusitis or severe oral-pharyngeal infections.
9. Smoker.
10 Years
ALL
Yes
Sponsors
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Bluestone Pharma
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University, Department of Dentistry and Oral Health
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Sebastian Schlafer, Dr.
Role: primary
Elisabeth Reichardt, Dr.
Role: backup
Other Identifiers
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1-10-72-77-24
Identifier Type: -
Identifier Source: org_study_id