Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01954849 | Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients | PHASE2 | COMPLETED | 60 | — | — | Aug 1, 2014 | Dec 1, 2014 | Aug 19, 2015 | 1 | Canada |
Gingivitis will be assessed by gingival index: 0 - Absence of gingival inflammation 1. \- Mild inflammation: slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit 2. \- Mild inflammation: criteria as above, but involving the entire marginal or papillary gingival unit 3. \- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4. \- Severe inflammation: marked redness, edema, and/or hypertrophy of marginal or papillary gingival unit; spontaneous bleeding, congestion or ulceration.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| Probiotic formulation | DIETARY_SUPPLEMENT | - |
Inclusion criteria: * Are male or female between the ages of 11 to 18 years * Have mild to moderate gingivitis as determined by dentist (GI of at least 1 to a maximum of 2) * Are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars fo...