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.
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
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).
- Conditions
- Dentin Hypersensitivity
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Stannous fluoride and Potassium nitrate Dentifrice |
| 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. Receives: Drug: Stannous fluoride Dentifrice |
| 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. Receives: Drug: Potassium nitrate Dentifrice |
| 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. Receives: Drug: Vehicle Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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.
- First posted10 Oct 2025
- Study start16 Sep 2025
- Primary completion11 Aug 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pejmon Amini, Principal investigator, Silverstone ResearchJeffery L Milleman, Principal investigator, Salus Research, IncJohn T Gallob, Principal investigator, All Sum Research
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice
- ClinicalTrials.gov ID
- NCT07215767
- Acronym / sponsor ID
- 300140
- Conditions
- Dentin Hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 11 Aug 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Drug: Stannous fluoride and Potassium nitrate DentifriceParticipants 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 | Drug: Stannous fluoride DentifriceParticipants 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 | Drug: Potassium nitrate DentifriceParticipants 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 | Drug: Vehicle DentifriceParticipants 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. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stannous fluoride and Potassium nitrate DentifriceFluoride dentifrice | Drug | Test Dentifrice |
| Stannous fluoride DentifriceFluoride dentifrice | Drug | Reference Dentifrice 1 |
| Potassium nitrate DentifriceNon-fluoride dentifrice | Drug | Reference Dentifrice 2 |
| Vehicle DentifricePlacebo dentifrice | Drug | Reference Dentifrice 3 |
Primary outcome
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
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)
Time frame: 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.
4 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, Day 4, Week 1, Week 2, Week 4 and Week 8
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)
Time frame: Baseline, Day 4, Week 1, Week 2, Week 4 and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pejmon Amini principal investigator
Silverstone Research
Jeffery L Milleman principal investigator
Salus Research, Inc
John T Gallob principal investigator
All Sum Research
3 sites in 1 country: see every site and its status.
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.