Probiotic Treatment of Orthodontic Patients

Last updated: December 27, 2024
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Probiotic treatment

Clinical Study ID

NCT06751979
1-10-72-77-24
  • Ages > 10
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 theupper 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

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 hygieneproducts such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gumor 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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
October 02, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Aarhus University, Department of Dentistry and Oral Health

    Aarhus, 8000
    Denmark

    Active - Recruiting

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