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| ID | Type | Description | Link |
|---|---|---|---|
| 185428 | Other Identifier | Health Canada, Natural Health Products Directorate | |
| OCE VIP #20964 | Other Grant/Funding Number | Ontario Centres of Excellence |
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| Name | Class |
|---|---|
| Integra Medical Inc. | INDUSTRY |
| University of Toronto | OTHER |
| University of Western Ontario, Canada | OTHER |
| Ontario Centres of Excellence |
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This study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this study will be randomly assigned to receive either the probiotic treatment or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. They will also be assessed for the same measures at day 56, following a 28-day wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/or inflammatory cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic formulation | Experimental | Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days. |
|
| Placebo | Placebo Comparator | Placebo dissolving lozenge, with the exact same appearance as the treatment lozenge (including flavour, colour, shape and texture), and formulated with all the same ingredients except for the live bacteria, taken for 28 days at the same prescribed regimen as the probiotic lozenge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic formulation | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in gingivitis | Gingivitis will be assessed by gingival index: 0 - Absence of gingival inflammation
| 0, 14, 28, and 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced plaque | Reduction in levels of plaque as measured by a plaque index: 0 - No plaque in the gingival area
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in S. mutans | Reduced levels of S. mutans in plaque and saliva | 0, 14, 28, and 56 days |
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Cadieux, PhD | University of Western Ontario, Canada | Principal Investigator |
| Siew-Ging Gong, BDS, MS, MA, PhD. | University of Toronto, Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toronto Orthodontics Clinic | Toronto | Ontario | M5S 2J7 | Canada |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D007249 | Inflammation |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| INDUSTRY |
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| 0, 14, 28, and 56 days |
| Reduction in inflammation | Reduction in salivary cytokines IL-1, IL-6, IL-8, TNF-A, IL-12 and an increase in IL-10, and IL-13 as measured by immunofluorometric assay. | 0, 14, 28, and 56 days |
| D009057 |
| Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |