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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Probiotic treatment
Dietary supplementDaily intake of a lozenge containing the probiotic strain S. salivarius M18.
Placebo
Dietary supplementPlacebo
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Planimetric plaque quantification
Amount of dental plaque formed after 6 weeks of probiotic treatment
Time frame
6 weeksSecondary outcomes
1
Prevalence of S. salivarius
The prevalence and abundance of S. salivarius M18 in saliva, tongue coating and dental plaque samples, as determined by 16S rRNA gene sequencing
Time frame
Immediately after intervention2
Gingivitis
Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI)
Time frame
Immediately after intervention3
Plaque pH
The acidogenic potential of dental plaque, as determined by pH ratiometry
Time frame
Immediately after interventionOther outcomes
1
Microbiome composition
The effects of probiotic treatment on the overall composition of the oral microbiome, assessed by next generation sequencing
Time frame
Immediately after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Bluestone Pharma
Collaborator
Source ClinicalTrials.gov