Probiotic treatment for orthodontic patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a lozenge containing the probiotic strain S. salivarius M18 on dental plaque and caries in healthy orthodontic patients. Participants will receive either the probiotic treatment or a placebo while undergoing orthodontic treatment with fixed appliances. The study aims to assess changes in the formation, composition, and virulence of dental plaque over the treatment period. Eligible participants must have a certain level of plaque and be generally healthy with at least 20 natural teeth.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aarhus University, Department of Dentistry and Oral Health
  Aarhus, Denmark Recruiting

Study contacts

• Study coordinator: Sebastian Schlafer, DDS
• Email: sebastians@dent.au.dk
• Phone: 42976020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.