Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluoride · 5 trials · 4 indications
SMHR test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100.
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
| Arm | Type | Description |
|---|---|---|
| Low ppm fluoride dentifrice | EXPERIMENTAL | Low ppm fluoride as sodium fluoride in a silica base dentifrice |
| Medium ppm fluoride dentifrice | EXPERIMENTAL | Medium ppm fluoride as sodium fluoride in a silica base dentifrice |
| High ppm fluoride dentifrice | EXPERIMENTAL | High ppm fluoride as sodium fluoride in a silica base dentifrice |
| No fluoride dentifrice | PLACEBO_COMPARATOR | no added fluoride in a silica base dentifrice |
| Fluoride free toothpaste | PLACEBO_COMPARATOR | toothpaste with no fluoride |
| 1426ppm Fluoride Toothpaste | EXPERIMENTAL | Experimental toothpaste containing 1426 ppm Fluoride |
| 1000 ppm Fluoride Toothpaste | EXPERIMENTAL | Experimental toothpaste containing 1000 ppm Fluoride |
| 500 ppm Toothpaste | EXPERIMENTAL | Experimental toothpaste containing 500 ppm Fluoride |
| NaF toothpaste (1450 parts per million [ppm] fluoride [F]) | EXPERIMENTAL | Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| NaF toothpaste (1400ppmF) | ACTIVE_COMPARATOR | Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF)) | ACTIVE_COMPARATOR | Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| Placebo toothpaste (0ppmF) | PLACEBO_COMPARATOR | Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| Test Product | EXPERIMENTAL | Participants will rinse twice daily (morning and evening) with 10 milliliters (mL) of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. |
| Negative Control | OTHER | Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. |
| Placebo | PLACEBO_COMPARATOR | Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. |
| Test Dentifrice + Test Mouth Rinse (MR) | EXPERIMENTAL | Test fluoride dentifrice and test fluoride MR |
| Test Dentifrice + Sterile Water Rinse | EXPERIMENTAL | Test fluoride dentifrice and sterile water rinse |
| Placebo Dentifrice + Test MR | EXPERIMENTAL | Placebo dentifrice and test fluoride rinse |
| Reference Dentifrice + Sterile Water Rinse | ACTIVE_COMPARATOR | Marketed fluoride dentifrice with sterile water rinse |
| Placebo Dentifrice + Sterile Water Rinse | PLACEBO_COMPARATOR | Placebo dentifrice and sterile water rinse |
| Name | Type | Description |
|---|---|---|
| sodium fluoride | DRUG | fluoride as sodium fluoride |
| no added fluoride in a silica base | DRUG | no added fluoride |
| Fluoride | DRUG | Fluoride Toothpaste |
| Placebo | DRUG | Fluoride free toothpaste |
| Sodium Fluoride (NaF) | DRUG | Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF |
| Potassium oxalate | DEVICE | Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride |
| Sodium monoflurophosphate | DRUG | United Kingdom marketed fluoride toothpaste |
| Sterile water | DRUG | Sterile water rinse |
Inclusion Criteria: * intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
Fluoride is used for dentin sensitivity, dental caries, tooth erosion, and enamel erosion. It is a small molecule being developed by GSK plc for these oral health conditions. Clinical studies have evaluated fluoride toothpastes and oral rinses for their effects on caries and enamel remineralization.
GSK plc (ticker: GSK) is the developer of Fluoride. The company has conducted clinical trials evaluating fluoride in toothpaste and oral rinse formulations for dental caries, enamel erosion, and dentin sensitivity.
Fluoride is in Phase 3 clinical development. GSK has completed Phase 3 trials for dental caries and enamel erosion, as well as a Phase 2 trial for dentin sensitivity. It remains investigational and is not approved for these indications.
Fluoride has been studied in several completed trials, including NCT00708305 and NCT01607411 for dental caries, NCT01641237 for enamel erosion, and NCT03238352 for dentin sensitivity. These trials were conducted in the United States with healthy volunteers.
Fluoride is the active ingredient in fluoride toothpastes. GSK has evaluated experimental fluoride toothpastes in clinical trials, such as NCT01607411, which tested children's toothpastes in an in-situ caries model. The studies assess fluoride's effect on caries prevention and enamel remineralization.