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Also known as NaF
NaF/ KNO3/isopentane Dentifrice · 2 trials · 2 indications
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.
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 |
|---|---|---|
| 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) |
| 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 | DRUG | Fluoride |
| Placebo | DRUG | Placebo |
| NaMFP | DRUG | Fluoride |
| 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: * 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/KNO3/isopentane dentifrice is an investigational toothpaste formulation developed by GSK plc for oral care. It is being studied in the areas of caries and dental erosion, two conditions involving loss of tooth mineral. The product combines sodium fluoride with potassium nitrate and isopentane in a single dentifrice.
NaF/KNO3/isopentane dentifrice is being developed for caries and dental erosion. Caries is tooth decay caused by demineralization of enamel, while dental erosion is mineral loss from acid exposure. The formulation is intended as a remineralizing and fluoride-delivering oral care product for adults.
GSK plc, which trades under the ticker GSK, is the developer of NaF/KNO3/isopentane dentifrice. The company is studying the formulation in clinical trials of fluoride toothpastes for caries and dental erosion.
NaF/KNO3/isopentane dentifrice is in Phase 3 development. It is investigational and has not been approved. One Phase 3 trial has been completed, and a related Phase 2 trial has also been completed.
Two completed trials have studied this dentifrice. NCT00708097 was a Phase 3 in situ caries efficacy study of fluoride toothpastes with 57 enrolled participants in the United States. NCT00752089 was a Phase 2 in situ remineralization and fluoride uptake study in dental erosion with 20 participants.
NaF is an alternative name used for NaF/KNO3/isopentane dentifrice. NaF refers to sodium fluoride, one component of the formulation, so searches for NaF in this context point to the same GSK dentifrice product.