Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sodium fluoride toothpaste
fluoride toothpaste · 2 trials · 3 indications
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.
| Arm | Type | Description |
|---|---|---|
| Run in | OTHER | Placebo |
| Sodium Fluoride Toothpaste | EXPERIMENTAL | Sodium fluoride toothpaste |
| Amine Fluoride Toothpaste | ACTIVE_COMPARATOR | Amine Fluoride |
| 675ppmf toothpaste | OTHER | Dose response |
| Sodium monofluorophosphate/sodium fluoride Toothpaste | ACTIVE_COMPARATOR | Sodium monofluorophosphate/sodium fluoride Toothpaste |
| 0 ppmf toothpaste | PLACEBO_COMPARATOR | - |
| Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F] | ACTIVE_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| NaF/Carbopol toothpaste (1400 ppm F) | EXPERIMENTAL | Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| NaMFP/NaF toothpaste (1450 ppm F) | ACTIVE_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| NaF toothpaste (250 ppm F) | ACTIVE_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| Placebo toothpaste (0 ppm F) | PLACEBO_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth. |
| Name | Type | Description |
|---|---|---|
| Sodium Fluoride Toothpaste | DRUG | Test product |
| Amine Fluoride Toothpaste | DRUG | Test product |
| Sodium monofluorophosphate/Sodium Fluoride Toothpaste | DRUG | test product |
| Placebo | DRUG | placebo and washout treatment |
| 675 ppmf toothpaste | DRUG | dose response |
| Placebo toothpaste | DRUG | Fluoride free toothpaste (0 ppm F) |
Inclusion Criteria: * Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form * Age:Aged 18 to 80 years inclusive * Compliance: Understands and is willing,...
Fluoride toothpaste is used to help prevent dental caries, also known as tooth decay. GSK plc, which trades under the ticker GSK, has developed it as a small molecule product. The clinical program studied it in adults aged 18 years and older, including healthy volunteers and partial denture wearers, in caries-related research settings.
Fluoride toothpaste is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical development program for this small molecule product in the caries indication. GSK is the developer named for the two completed Phase 3 trials that studied the product in adults.
Fluoride toothpaste has been studied in Phase 3 clinical development. Two Phase 3 trials have been completed, and neither is currently active. The program enrolled a total of 125 participants across the two studies, which were randomized, double blind, and placebo controlled. It is an investigational product in the caries research setting.
Fluoride toothpaste has been studied in two completed Phase 3 trials. NCT01005966, titled In Situ Caries Model of Fluoride Toothpastes, enrolled 65 participants. NCT00708123, titled In Situ Caries of Fluoride Toothpastes, enrolled 60 participants. Both trials included adults aged 18 years and older and enrolled healthy volunteers.
Yes, fluoride toothpaste is also known as sodium fluoride toothpaste. The names refer to the same product developed by GSK plc under the ticker GSK. Readers searching for sodium fluoride toothpaste or sodium fluoride toothpaste will find the same Phase 3 caries program, which includes the completed trials NCT01005966 and NCT00708123.
The fluoride toothpaste clinical program enrolled 125 participants in total across two completed Phase 3 trials. NCT01005966 enrolled 65 participants, and NCT00708123 enrolled 60 participants. Both studies were randomized, double blind, and placebo controlled, and both included adults aged 18 years and older.