Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.254% w/w fluoride and 5% KNO3 · 1 trial · 1 indication
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = \[(E1-R)/(E1-B)\]\*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
| Arm | Type | Description |
|---|---|---|
| Test product | EXPERIMENTAL | Participants will apply a full ribbon of the test product (1.5 grams \[g\]) containing 0.254% w/w sodium fluoride and 5% KNO3. |
| Comparator Product | ACTIVE_COMPARATOR | Participants will apply a full ribbon of the comparator product (1.5 g orally) containing 0.454% w/w stannous fluoride. |
| Placebo Product | PLACEBO_COMPARATOR | Participants will apply a full ribbon of the placebo (1.5 g orally) containing 5% KNO3. |
| Name | Type | Description |
|---|---|---|
| 0.254% w/w sodium fluoride and 5% KNO3 | DRUG | Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres \[mL\] of tap water for 10 seconds before expectorating again. |
| 0.454% w/w stannous fluoride | DRUG | Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again. |
| 5% KNO3 | DRUG | Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent. * Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive. * Participant who is willing and able to comply with scheduled visits, treatment plan, and other study ...
0.254% w/w fluoride and 5% KNO3 is an investigational toothpaste formulation developed by GSK plc for tooth erosion. It combines fluoride with potassium nitrate and is being studied as a small molecule therapy. It is not yet approved and remains in clinical development.
0.254% w/w fluoride and 5% KNO3 is being developed for tooth erosion. A Phase 3 in situ erosion study evaluated the experimental toothpaste in this indication. The formulation is intended for use as a dental care product, though it has not been approved for marketing.
GSK plc, which trades under the ticker GSK, is the developer of 0.254% w/w fluoride and 5% KNO3. The company sponsored the Phase 3 in situ erosion study of the experimental toothpaste. GSK is a global pharmaceutical and consumer healthcare company.
0.254% w/w fluoride and 5% KNO3 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for tooth erosion or any other indication.
0.254% w/w fluoride and 5% KNO3 has been studied in one completed Phase 3 trial, NCT03296072, titled an In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste. The trial enrolled 62 healthy adult volunteers in the United States and was randomized, double blind, and placebo controlled.