Probiotic treatment for orthodontic patients

Effect of the Probiotic Strain Streptococcus Salivarius M18 on de Novo Formation and Composition of Dental Biofilm in Orthodontic Patients: A Randomized Double-blind Placebo-controlled Clinical Trial.

This study is testing if a probiotic lozenge can help reduce dental plaque and cavities in healthy orthodontic patients wearing braces.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 1 site (Aarhus)
• Trial ID: NCT06751979 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are generally healthy individuals aged 10 and older who are currently undergoing orthodontic treatment and have a moderate level of dental plaque.

Not a fit: Patients with significant oral health issues, allergies to probiotics, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could reduce dental plaque and caries in orthodontic patients, improving oral health outcomes.

How similar studies have performed: While the specific probiotic approach may be novel, other studies have shown promising results with probiotics in oral health.

Eligibility criteria

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 this trial is running

Aarhus

• Aarhus University, Department of Dentistry and Oral Health — Aarhus, Denmark (RECRUITING)

Study contacts

• Study coordinator: Sebastian Schlafer, DDS

Conditions: Dental Plaque, Dental Caries