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Stannous fluoride and nitrate Dentifrice · 1 trial · 1 indication
Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Schiff sensitivity score = mean score of the two 'Test Teeth' (selected at Baseline). Change from Baseline is calculated for each 'Test Tooth' first before calculating mean change for the two 'Test Teeth', where change from Baseline = Week 8 score minus Baseline score.
Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in g. At Baseline, upper force setting will be 20g; at Week 8, upper force setting will be 80g. An increase in tactile threshold (g) indicates improvement. Tactile threshold (g) = mean value for the two 'Test Teeth'. Change from Baseline is calculated for each 'Test Tooth' first before calculating mean change for the two 'Test Teeth', where change from Baseline in tactile threshold (g) at Week 8 = Week 8 value minus Baseline value.
| Arm | Type | Description |
|---|---|---|
| Test Dentifrice | EXPERIMENTAL | Participants will be instructed to dose the toothbrush head with the Test Dentifrice (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
| Reference Dentifrice 1 | ACTIVE_COMPARATOR | Participants will be instructed to dose the toothbrush head with Reference Dentifrice 1 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
| Reference Dentifrice 2 | ACTIVE_COMPARATOR | Participants will be instructed to dose the toothbrush head with Reference Dentifrice 2 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
| Reference Dentifrice 3 | PLACEBO_COMPARATOR | Participants will be instructed to dose the toothbrush head with Reference Dentifrice 3 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
| Name | Type | Description |
|---|---|---|
| Stannous fluoride and Potassium nitrate Dentifrice | DRUG | Fluoride dentifrice |
| Stannous fluoride Dentifrice | DRUG | Fluoride dentifrice |
| Potassium nitrate Dentifrice | DRUG | Non-fluoride dentifrice |
| Vehicle Dentifrice | DRUG | Placebo dentifrice |
Inclusion Criteria: * Provision of signed and dated informed consent document (and assent document, if appropriate) * Participant is biologically male or female. * Participant is 12 to 65 years of age, inclusive, at the time of signing the consent/assent form. * Participant is in good general, oral...
Stannous fluoride and nitrate Dentifrice is an investigational small molecule being developed for the treatment of dentin hypersensitivity, a condition characterized by sharp pain in teeth when exposed to hot, cold, sweet, or acidic stimuli. It is formulated as a dentifrice, or toothpaste, intended to reduce this tooth sensitivity.
Stannous fluoride and nitrate Dentifrice is being developed by Haleon plc, a consumer healthcare company traded on the London Stock Exchange under the ticker HLN. The company is conducting clinical research to evaluate the dentifrice's efficacy in reducing dentin hypersensitivity.
Stannous fluoride and nitrate Dentifrice is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its antihypersensitivity efficacy in patients with dentin hypersensitivity.
Stannous fluoride and nitrate Dentifrice has one completed Phase 3 clinical trial, registered as NCT07215767, titled 'Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice.' The trial enrolled 688 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 12 years and older.
Stannous fluoride and nitrate Dentifrice is not FDA approved. It is an investigational product currently in Phase 3 clinical development. A completed Phase 3 trial has evaluated its efficacy for dentin hypersensitivity, but regulatory approval has not been granted.