RecruitingNot Applicable

Probiotic Treatment of Orthodontic Patients

Denmark60 participantsStarted 2024-10-02

Plain-language 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.

Who can participate

Age range10 Years

SexALL

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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.

What they're measuring

Planimetric plaque quantification

Timeframe: 6 weeks

Trial details

NCT IDNCT06751979

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03

Contact for this trial

Sebastian Schlafer, DDS

42976020 sebastians@dent.au.dk

View on ClinicalTrials.gov More Dental Plaque trials