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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 for caries prevention in healthy subjects, including partial denture wearers. It is an investigational small molecule being developed by GSK plc for the ENT therapeutic area. The product is intended for use in adults aged 18 years and older.
Fluoride Toothpaste is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted clinical trials to evaluate the product's effects on caries in healthy subjects.
Fluoride Toothpaste is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. Two Phase 3 trials have been completed to assess its use in caries prevention.
Fluoride Toothpaste has been studied in two completed Phase 3 trials: NCT00708123, titled "In Situ Caries of Fluoride Toothpastes," and NCT01005966, titled "In Situ Caries Model of Fluoride Toothpastes." Both trials enrolled healthy adults aged 18 years and older.
Fluoride Toothpaste is the name used for this specific investigational product developed by GSK plc. No alternative names have been associated with this product in the clinical trial records.
A total of 65 participants have been enrolled across the completed Fluoride Toothpaste clinical trials. The trials were randomized and placebo-controlled, and they included healthy volunteers. The studies were not double-blinded.