Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 5% KNO3
5% KNO3/ 0.2542% NaF dentifrice with 0.5% spherical silica · 1 trial · 1 indication
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
| Arm | Type | Description |
|---|---|---|
| Test Product 1 | EXPERIMENTAL | Participants will be instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. |
| Test Product 2 | EXPERIMENTAL | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. |
| Reference Product 1 | ACTIVE_COMPARATOR | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. |
| Reference Product 2 | ACTIVE_COMPARATOR | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. |
| Name | Type | Description |
|---|---|---|
| 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica | DRUG | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
| 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP | DRUG | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
| 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica | DRUG | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
| 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP | DRUG | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Male and female participants who, at the time of screening, are between the ages of...