Overview
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
Inclusion Criteria:
- Generally healthy males and females ≥ 10 years of age.
- Able to read and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth.
- Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw > 6 months.
- An average plaque score of > 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.
Exclusion Criteria:
- Significant oral soft tissue pathology based on a visual examination.
- 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.
- History of allergies to milk proteins.
- History of allergies towards probiotics.
- Self-reported as pregnant or nursing.
- Self-reported serious medical conditions.
- Antibiotic or anti-inflammatory medication within 30 days of screening visit.
- Acute sinusitis or severe oral-pharyngeal infections.
- Smoker.