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| Name | Class |
|---|---|
| Bluestone Pharma | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic treatment | Dietary Supplement | Daily intake of a lozenge containing the probiotic strain S. salivarius M18. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Planimetric plaque quantification | Amount of dental plaque formed after 6 weeks of probiotic treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after intervention |
| Gingivitis |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome composition | The effects of probiotic treatment on the overall composition of the oral microbiome, assessed by next generation sequencing | Immediately after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Schlafer, DDS | Contact | 42976020 | +45 | sebastians@dent.au.dk |
| Elisabeth Reichardt, DDS | Contact | 17620130691 | +49 | elisabeth.reichardt@dent.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University, Department of Dentistry and Oral Health | Recruiting | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
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This clinical trial applies a randomized double-blind placebo-controlled design with two parallel arms.
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| Placebo | Dietary Supplement | Placebo |
|
Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI)
| Immediately after intervention |
| Plaque pH | The acidogenic potential of dental plaque, as determined by pH ratiometry | Immediately after intervention |