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Probiotic formulation · 1 trial · 2 indications
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...
The probiotic formulation is being studied for the treatment of gingivitis, a common form of gum disease that causes inflammation. It is intended for use in pediatric patients, with a clinical trial evaluating its effects in children aged 11 years and older.
Integra LifeSciences Holdings Corporation (NASDAQ: IART) is developing the probiotic formulation. The company is conducting clinical research to evaluate the probiotic's potential in treating gingivitis in pediatric patients.
The probiotic formulation is in Phase 2 clinical development. A Phase 2 trial has been completed to assess its safety and efficacy in treating gingivitis in pediatric patients. The formulation is investigational and has not been approved for commercial use.
The probiotic formulation has been evaluated in one clinical trial, NCT01954849, titled "Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients." This Phase 2, randomized, double-blind, placebo-controlled study enrolled 60 participants in Canada and has been completed.
The probiotic formulation is not known to be the same as any other marketed drug. It is a distinct investigational product being developed by Integra LifeSciences Holdings Corporation for the treatment of gingivitis in pediatric patients.