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Dentin HypersensitivityPhase 3NCT07215767

Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice

A Phase 3 study testing Stannous fluoride and Potassium nitrate Dentifrice, Stannous fluoride Dentifrice and Potassium nitrate Dentifrice in people with Dentin Hypersensitivity, run by HALEON at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and potassium nitrate (KNO3) dentifrice (Investigational Product), compared to SnF2 only, KNO3 only and Vehicle dentifrices, after 8 weeks twice daily use. Read more about this study

Who is it for?
Ages 12 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dentin Hypersensitivity
What is being tested?
Stannous fluoride and Potassium nitrate Dentifrice, Stannous fluoride Dentifrice and Potassium nitrate Dentifrice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
688 participants
Where
3 sitesUnited States
Study dates
16 Sep 2025to 11 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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 and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or well-being, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
  • Participant has a history of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
  • Participant has a minimum of 2 non-adjacent teeth (incisors, canines or premolars), in different quadrants, with exposed dentin due to facial/cervical erosion, abrasion or gingival recession, and clinically confirmed dentin hypersensitivity to tactile and evaporative (air) stimuli at Screening and Baseline.

Who cannot join

  • Female participant who is pregnant at Screening and Baseline, or is intending to become pregnant during the study.
  • Female participant who is breastfeeding.
  • Participant with known or suspected intolerance or hypersensitivity to any of the study products, any of their stated ingredients or closely related compounds.
  • Participant is participating in, or has participated in, other studies (including non-medicinal studies) involving an Investigational Product within 30 days of Screening or plans to participate in other studies (including non-medicinal studies) during this study.
  • Participant has participated in a tooth sensitivity study within 8 weeks of Screening.
  • Participant is currently using an oral care product indicated for dentin hypersensitivity relief or care of sensitive teeth or has used an antihypersensitivity oral care product within 8 weeks of Screening.
Show all 15Show fewer
  • Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity.
  • Participant has had professional tooth de-sensitising treatment within 8 weeks of Screening.
  • Participant has had a tooth bleaching procedure within 8 weeks of Screening.
  • Participant has had dental prophylaxis within 4 weeks of Screening.
  • Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
  • Participant with evidence of current/recent active dental caries or treatment for decay within 12 months of Screening.
  • Participant who, in the opinion of the investigator or dentally qualified designee, is at high risk of dental caries.
  • Participant with specific dentition exclusions for 'Test Teeth'.
  • Participant has taken antibiotics in the 2 weeks prior to Screening or Baseline.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Salus Research, Inc.

    Fort Wayne, Indiana, 46825

  • Silverstone Research

    Las Vegas, Nevada, 89146

  • All Sum Research Limited

    Melbourne, Florida, 32935

Other trials in United States

About this study

The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and potassium nitrate (KNO3) dentifrice (Investigational Product), compared to SnF2 only, KNO3 only and Vehicle dentifrices, after 8 weeks twice daily use.

Read the detailed description

This will be a multi-center, randomized, controlled, double-blind, 4-treatment arm, stratified, parallel design, Phase III clinical study in healthy participants, aged 12-65 years inclusive, with self-reported and clinically confirmed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be stratified and randomized to one of four study dentifrices. Approximately 630 qualifying participants will be randomized to study treatment (approximately 180 participants each to the SnF2 and KNO3 dentifrice, the SnF2 dentifrice and the KNO3 dentifrice; approximately 90 participants to the Vehicle dentifrice). Dentin hypersensitivity will be clinically assessed at Screening and Baseline, and after 3 days, 1 week, 2 weeks, 4 weeks and 8 weeks treatment (7 study visits).

Being tested
Stannous fluoride and Potassium nitrate Dentifrice, Stannous fluoride Dentifrice, Potassium nitrate Dentifrice, Vehicle Dentifrice
Medical subject headings
Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stannous fluoride and Potassium nitrate DentifriceDrug

    Fluoride dentifrice

  • Stannous fluoride DentifriceDrug

    Fluoride dentifrice

  • Potassium nitrate DentifriceDrug

    Non-fluoride dentifrice

  • Vehicle DentifriceDrug

    Placebo dentifrice

Study groups in NCT07215767
Study groupRoleWhat they receive
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.
Receives: Drug: Stannous fluoride and Potassium nitrate Dentifrice
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.
Receives: Drug: Stannous fluoride Dentifrice
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.
Receives: Drug: Potassium nitrate Dentifrice
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.
Receives: Drug: Vehicle Dentifrice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Schiff sensitivity score at Week 8 (Test Dentifrice Versus [Vs] Reference Dentifrices 1, 2 and 3)

    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.

    Measured: Baseline and Week 8

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

    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.

    Measured: Baseline and Week 8

Secondary outcomes (4)
  1. 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)

    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 the stimulus). A decrease in Schiff sensitivity score indicates improvement. Schiff sensitivity score = mean score of 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 = score at given timepoint minus Baseline score.

    Measured: Baseline, Day 4, Week 1, Week 2 and Week 4

  2. 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)

    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 other timepoints, 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) = value at given timepoint minus Baseline value.

    Measured: Baseline, Day 4, Week 1, Week 2 and Week 4

  3. 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)

    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 the stimulus). A decrease in Schiff sensitivity score indicates improvement. Schiff sensitivity score = mean score of 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 = score at given timepoint minus Baseline score.

    Measured: Baseline, Day 4, Week 1, Week 2, Week 4 and Week 8

  4. Change from Baseline in tactile threshold (g) at Day 4, Week 1, Week 2, Week 4 and Week 8 (Reference Dentifrices 1 and 2 Vs Reference Dentifrice 3)

    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, the upper force setting will be 20g; at other timepoints, the 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) = value at given timepoint minus Baseline value.

    Measured: Baseline, Day 4, Week 1, Week 2, Week 4 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study start16 Sep 2025
  3. Primary completion11 Aug 2026
  4. Study completion11 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215767
Sponsor's protocol ID
300140
Status last verified
Aug 2026
First submitted
6 Oct 2025
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stannous fluoride and Potassium nitrate Dentifrice, Stannous fluoride Dentifrice and Potassium nitrate Dentifrice in people with Dentin Hypersensitivity, run by HALEON at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Schiff sensitivity score at Week 8 (Test Dentifrice Versus [Vs] Reference Dentifrices 1, 2 and 3) (time frame: Baseline and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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