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Stannous fluoride and nitrate Dentifrice

Phase 3

Dentin Hypersensitivity | Small molecule | Other |Haleon plc|Last Updated: Feb 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment850
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07215767Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel DentifricePHASE3 RECRUITING 850Sep 16, 2025Aug 1, 2026Feb 5, 20263 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in Schiff sensitivity score at Week 8 (Test Dentifrice Versus [Vs] Reference Dentifrices 1, 2 and 3)
Baseline and Week 8

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.

Change from Baseline in tactile threshold (grams [g]) at Week 8 (Test Dentifrice Vs Reference Dentifrices 1, 2 and 3)
Baseline and Week 8

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.

Secondary Endpoints
Change from Baseline in Schiff sensitivity score at Day 4, Week 1, Week 2 and Week 4 (Test Dentifrice Vs Reference Dentifrices 1, 2 and 3)
Baseline, Day 4, Week 1, Week 2 and Week 4
Change from Baseline in tactile threshold (g) at Day 4, Week 1, Week 2 and Week 4 (Test Dentifrice Vs Reference Dentifrices 1, 2 and 3)
Baseline, Day 4, Week 1, Week 2 and Week 4
Change from Baseline in Schiff sensitivity score at Day 4, Week 1, Week 2, Week 4 and Week 8 (Reference Dentifrices 1 and 2 Vs Reference Dentifrice 3)
Baseline, Day 4, Week 1, Week 2, Week 4 and Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Test DentifriceEXPERIMENTALParticipants 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 1ACTIVE_COMPARATORParticipants 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 2ACTIVE_COMPARATORParticipants 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 3PLACEBO_COMPARATORParticipants 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.
Interventions
NameTypeDescription
Stannous fluoride and Potassium nitrate DentifriceDRUGFluoride dentifrice
Stannous fluoride DentifriceDRUGFluoride dentifrice
Potassium nitrate DentifriceDRUGNon-fluoride dentifrice
Vehicle DentifriceDRUGPlacebo dentifrice
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Eligibility Criteria
Age Range12 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07215767primaryCompletionDate: changed
LOWMay 24, 2026NCT07215767studyFirstPostDate: changed