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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...
It is an experimental toothpaste formulation containing 5% potassium nitrate, 0.2542% sodium fluoride, and 0.5% spherical silica. It is being studied for oral hygiene, specifically for stain and plaque removal. It is a small molecule dentifrice developed by GSK plc and is not a marketed consumer product.
It is being studied for oral hygiene, with the clinical program focused on stain and plaque removal. The single Phase 2 trial enrolled healthy adult volunteers aged 18 and older in the United States. It is an investigational dentifrice, not an approved treatment for any condition.
GSK plc, which trades under the ticker GSK, is the developer of this dentifrice. The company sponsored the Phase 2 study evaluating the formulation. No other developer or partner is associated with the asset in the clinical record.
It is in Phase 2. One Phase 2 trial has been completed, and no trials are currently active. The study was randomized, double blind, and active controlled, and it enrolled 123 participants. The formulation remains investigational and is not an approved product.
The asset has been studied in NCT03267511, titled A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices. That Phase 2 trial is completed, enrolled 123 healthy volunteers aged 18 and older in the United States, and used an active-controlled, randomized, double-blind design.
Yes. 5% KNO3 is a shortened name for the same asset, which is also written as 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica. The full name reflects the potassium nitrate, sodium fluoride, and spherical silica components of the formulation. Searches for either name refer to the same GSK dentifrice.