Dental Plaque, Dental Caries
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotic treatment
Daily intake of a lozenge containing the probiotic strain S. salivarius M18.
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Bluestone Pharma
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This clinical trial applies a randomized double-blind placebo-controlled design with two parallel arms.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Planimetric plaque quantification | 6 weeks | Amount of dental plaque formed after 6 weeks of probiotic treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of S. salivarius | Immediately after intervention | The prevalence and abundance of S. salivarius M18 in saliva, tongue coating and dental plaque samples, as determined by 16S rRNA gene sequencing |
| Gingivitis | Immediately after intervention | Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI) |
| Plaque pH | Immediately after intervention | The acidogenic potential of dental plaque, as determined by pH ratiometry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiome composition | Immediately after intervention | The effects of probiotic treatment on the overall composition of the oral microbiome, assessed by next generation sequencing |
Countries
Denmark
Contacts
Primary ContactSebastian Schlafer, DDS
Backup ContactElisabeth Reichardt, DDS
Outcome results
None listed