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 combination being studied for the treatment of tooth erosion. It is a small molecule product developed by GSK plc (GSK). The active ingredients are fluoride and potassium nitrate, which are intended to help protect tooth enamel from erosive damage.
GSK plc (ticker: GSK) is the developer of 0.254% w/w fluoride and 5% KNO3, an investigational toothpaste for tooth erosion. The company is conducting clinical research to evaluate the product's effectiveness in reducing enamel erosion.
0.254% w/w fluoride and 5% KNO3 is in Phase 3 clinical development for tooth erosion. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with no active trials currently ongoing.
0.254% w/w fluoride and 5% KNO3 was studied in a completed Phase 3 clinical trial, NCT03296072, titled "In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste." This randomized, double-blind, placebo-controlled trial enrolled 62 healthy adult volunteers in the United States.
0.254% w/w fluoride and 5% KNO3 is an experimental toothpaste formulation containing fluoride and potassium nitrate, ingredients commonly found in sensitivity toothpastes. However, it is an investigational product and not marketed under the Sensodyne brand. GSK plc develops both, but this specific combination is still in clinical trials.