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Recruiting Not applicable

Probiotic Treatment of Orthodontic Patients

NCT06751979 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-10-02
Last updated
2024-12-30

Condition(s) studied

Dental PlaqueDental Caries

Investigational drug(s) / intervention(s)

Probiotic treatmentPlacebo

Probiotic treatment: Daily intake of a lozenge containing the probiotic strain S. salivarius M18.

Placebo: Placebo

Study summary

The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.

Eligibility

Sex
ALL
Min age
10 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Generally healthy males and females ≥ 10 years of age. 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: 1. Significant oral soft tissue pathology based on a visual examination. 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.

Primary outcome measure(s)

  • Planimetric plaque quantification — 6 weeks
    Amount of dental plaque formed after 6 weeks of probiotic treatment

Trial sites (1)

FacilityCityRegionStatus
Aarhus University, Department of Dentistry and Oral Health Aarhus Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06751979 on ClinicalTrials.gov ↗ ← All trials in Denmark