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NaF/ KNO3/isopentane Dentifrice · 1 trial · 1 indication
SMH test was used to assess 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 re-hardening of enamel surface. Percent 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 |
|---|---|---|
| Sodium fluoride/potassium nitrate/Isopentane dentifrice | EXPERIMENTAL | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. |
| NaF/KNO3 Dentifrice | EXPERIMENTAL | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. |
| NaF Dentifrice | ACTIVE_COMPARATOR | Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. |
| Placebo Dentifrice | PLACEBO_COMPARATOR | Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). |
| Name | Type | Description |
|---|---|---|
| NaF/ KNO3/isopentane Dentifrice | DRUG | Experimental toothpaste |
| NaF/KNO3 Dentifrice | DRUG | Experimental toothpaste |
| NaF Dentifrice | DRUG | Active comparator |
| Placebo Dentifrice | OTHER | Placebo comparator |
Inclusion Criteria: 1. Age: Aged between 18 and 78 2. Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons 3. Dentures: Currently wearing a removable mandibular partial denture with sufficient room...
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.