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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 toothpaste being developed by Haleon plc for dentin hypersensitivity, the tooth sensitivity caused by exposed dentin. It combines stannous fluoride with nitrate in a single oral care formulation. It is a small molecule product currently in Phase 3 clinical development.
Stannous fluoride and nitrate dentifrice is being developed for dentin hypersensitivity, a condition in which exposed dentin causes sharp tooth pain in response to stimuli such as cold, heat, or touch. The investigational dentifrice is intended to reduce this hypersensitivity. It is not yet approved and remains in clinical development.
Stannous fluoride and nitrate dentifrice is developed by Haleon plc, which trades under the ticker HLN. Haleon is the sponsor of the clinical program evaluating this investigational dentifrice for dentin hypersensitivity.
Stannous fluoride and nitrate dentifrice is in Phase 3 clinical development. The program includes one completed Phase 3 trial. The product is investigational and has not been approved for marketing.
Stannous fluoride and nitrate dentifrice has been studied in one completed Phase 3 trial, NCT07215767, titled a clinical study to investigate the antihypersensitivity efficacy of a novel dentifrice. The trial enrolled 688 participants in the United States, included ages 12 years and older, and was randomized, double blind, and placebo controlled.