Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NaF · 1 trial · 1 indication
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.
| Arm | Type | Description |
|---|---|---|
| NaF toothpaste(1450 ppmF) | EXPERIMENTAL | Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. |
| NaF toothpaste (1400 ppmF) | ACTIVE_COMPARATOR | Study toothpaste containing 1400 ppm F as NaF |
| NaMFP/NaF toothpaste (1450 ppmF) | ACTIVE_COMPARATOR | Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF |
| NaF toothpaste (675 ppmF) | ACTIVE_COMPARATOR | Study toothpaste containing 675 ppm F as NaF |
| Placebo toothpaste (0 ppmF) | PLACEBO_COMPARATOR | Fluoride free placebo toothpaste (0 ppm F) |
| Name | Type | Description |
|---|---|---|
| NaF | DRUG | Fluoride |
| Placebo | DRUG | Placebo |
| NaMFP | DRUG | Fluoride |
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 between 18 and 80 years. * Compliance:Understands and is willing,...
NaF is used for the prevention of caries (tooth decay) and dental erosion. It is a small molecule being developed by GSK plc for these dental conditions, which fall under the ear, nose, and throat therapeutic area.
NaF is a fluoride-based compound. It works by promoting remineralization of tooth enamel and inhibiting demineralization, which helps prevent caries and dental erosion. The exact molecular target is not specified.
NaF is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK.
NaF is in Phase 3 clinical development. One Phase 3 trial has been completed, and there are no active trials currently ongoing. The drug is investigational and not yet approved.
NaF has been studied in clinical trials including NCT00708097, a Phase 3 study on caries efficacy of fluoride toothpastes with 57 participants, and NCT00752089, a Phase 2 study on remineralization and fluoride uptake in dental erosion with 20 participants. Both trials are completed.