Probiotic Treatment of Orthodontic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Aarhus
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Probiotic treatment
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Aarhus
Lead sponsor
Bluestone Pharma
Collaborator
Source ClinicalTrials.gov