Dentin SensitivityNCT07802886
A Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
A study testing Test Toothpaste and Regular Fluoride Toothpaste in people with Dentin Sensitivity, run by HALEON at 1 site in United Kingdom.
Trial summary
The primary purpose of this study is to demonstrate the clinical efficacy of Test Toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride reference toothpaste, after 8 weeks twice daily use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Test Toothpaste and Regular Fluoride Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant provision of signed and dated informed consent before any study procedures are performed.
- Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions, and other study procedures.
- 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 wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
- Screening (Visit 1): Participant must have
- History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
- Good general oral health, with a minimum of 20 natural teeth.
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- Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:
- Exposed dentine due to facial/cervical erosion, abrasion, or gingival recession (EAR).
- Modified Gingival Index (MGI)= 0 directly adjacent to the exposed dentine (i.e., the test area only).
- Clinical mobility= 0.
- Clinically confirmed DH to both tactile and evaporative (air) stimuli: Qualifying tactile threshold less than or equal to (<=) 20g and Qualifying Schiff sensitivity score more than or equal to (>=) 2.
- Baseline (Visit 2, Pre-Treatment)
- Participant must have a minimum of two non-adjacent, accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both Screening (Visit 1) and Baseline (Visit 2).
- Tactile threshold <= 20g at Screening and Baseline.
- Schiff sensitivity score >= 2 at Screening and Baseline.
- The clinical examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline.
Who cannot join
- Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
- Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
- Female participant who is pregnant or intending to become pregnant during the study (self-reported).
- Female participant who is breastfeeding (self-reported).
- Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
- Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
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- Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1) 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 (Visit 1).
- Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used such a product within 8 weeks of Screening (Visit 1).
- 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 (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
- Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1).
- Baseline (Visit 2): Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the acclimatization period.
- Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
- Participant requires antibiotic prophylaxis for dental procedures.
- Participant has had professional tooth de-sensitizing treatment within 8 weeks of Screening (Visit 1).
- Participant has had a tooth bleaching procedure within 8 weeks of Screening (Visit 1).
- Participant has had dental prophylaxis or supragingival professional mechanical plaque removal (PMPR) within 4 weeks of Screening (Visit 1).
- Participant has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1).
- Participant has had subgingival instrumentation within 3 months of Screening (Visit 1).
- Participant with gross periodontal disease.
- Participant with a tongue or lip piercing in the area of the test teeth.
- Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
- Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- Participant with multiple dental implants which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- Participant has had orthodontic treatment (fixed or removable orthodontic braces/bands) within 6 months of Screening (Visit1).
- Participant with a fixed or removable orthodontic retainer which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes (e.g., Participant who is an intermittent user of a removable orthodontic retainer). Note: Teeth involved in a fixed orthodontic retainer may be used as 'test teeth' if, in the opinion of the investigator or dentally qualified designee, their selection would not impact study outcomes.
- Specific Dentition Exclusions for 'Test teeth':
- Tooth with evidence of current/recent caries.
- Tooth with (self-reported) treatment for decay within 12 months of Screening (Visit 1).
- Tooth with exposed dentine and deep, defective, or facial restorations.
- Tooth with a full crown or veneer.
- Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- Sensitive tooth with contributing etiologies other than EAR to exposed dentine.
- Sensitive tooth not expected to benefit from use of an anti-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.
- Participant has previously been enrolled in this study.
- Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Bristol Dental School
Bristol, BS1 2LY
Nicola West
About this study
Official title: An 8-Week, Randomised, Controlled, Double-Blind, Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
The primary purpose of this study is to demonstrate the clinical efficacy of Test Toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride reference toothpaste, after 8 weeks twice daily use.
Read the detailed description
This will be a single centre, 8-week, randomised, controlled, double-blind, 2-treatment arm, parallel group, stratified study in healthy participants with DH. Participants who meet the required study criteria at Screening and Baseline will be randomised to one of two treatments: a 5% CSPS toothpaste (Test Toothpaste) or a regular sodium fluoride toothpaste (Reference Toothpaste). Sufficient participants will be screened to ensure approximately 192 participants are randomised to investigational products (approximately 96 participants per treatment group) and approximately 172 participants complete the study (approximately 86 participants per treatment group).
- Conditions
- Dentin Sensitivity
- Being tested
- Test Toothpaste, Regular Fluoride Toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ToothpasteDevice
Toothpaste containing 5.0 % weight/weight (w/w) CSPS.
Regular Fluoride ToothpasteOther
Regular fluoride toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Participants will dose the toothbrush with a ribbon of Test Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning \& evening), for approximately 56 days. Receives: Device: Test Toothpaste |
| Reference Toothpaste (Negative Control) | Placebo comparator | Participants will dose the toothbrush with a ribbon of Reference Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning \& evening), for approximately 56 days. Receives: Other: Regular Fluoride Toothpaste |
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
Evaporative (air) sensitivity will be assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 3, where 0 equal to (=) Did not respond to air stimulation; 1= Responded to air stimulus but did not request discontinuation of stimulus; 2= Responded to air stimulus and requested discontinuation or moved from stimulus; 3= Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Week 8 score. Lower score indicates improvement.
Measured: Baseline and Week 8
Secondary outcomes (3)
Change from Baseline in Tactile Threshold gram (g) at Week 8
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline is calculated by subtracting Baseline value from Week 8 value.
Measured: Baseline and Week 8
Change from Baseline in Schiff Sensitivity Score at Weeks 2 and 4
Evaporative (air) sensitivity will be assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 3, where 0= Did not respond to air stimulation; 1= Responded to air stimulus but did not request discontinuation of stimulus; 2= Responded to air stimulus and requested discontinuation or moved from stimulus; 3= Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Weeks 2 and 4 scores. Lower score indicates improvement.
Measured: Baseline, Week 2 and Week 4
Change from Baseline in Tactile Threshold (g) at Weeks 2 and 4
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline is calculated by subtracting Baseline value from Week 2 and Week 4 values.
Measured: Baseline, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802886
- Sponsor's protocol ID
- 400367
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Randomised, Controlled, Double-Blind, Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
- ClinicalTrials.gov ID
- NCT07802886
- Acronym / sponsor ID
- 400367
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Sep 2026 (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 primary purpose of this study is to demonstrate the clinical efficacy of Test Toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride reference toothpaste, after 8 weeks twice daily use.
Detailed description
This will be a single centre, 8-week, randomised, controlled, double-blind, 2-treatment arm, parallel group, stratified study in healthy participants with DH. Participants who meet the required study criteria at Screening and Baseline will be randomised to one of two treatments: a 5% CSPS toothpaste (Test Toothpaste) or a regular sodium fluoride toothpaste (Reference Toothpaste). Sufficient participants will be screened to ensure approximately 192 participants are randomised to investigational products (approximately 96 participants per treatment group) and approximately 172 participants complete the study (approximately 86 participants per treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Device: Test ToothpasteParticipants will dose the toothbrush with a ribbon of Test Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning \& evening), for approximately 56 days. |
| Reference Toothpaste (Negative Control) | Placebo comparator | Other: Regular Fluoride ToothpasteParticipants will dose the toothbrush with a ribbon of Reference Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning \& evening), for approximately 56 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participant provision of signed and dated informed consent before any study procedures are performed.
- Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions, and other study procedures.
- 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 wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
- Screening (Visit 1): Participant must have
- History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
Key exclusion criteria (36 listed)
- Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
- Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
- Female participant who is pregnant or intending to become pregnant during the study (self-reported).
- Female participant who is breastfeeding (self-reported).
- Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
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 |
|---|---|---|
| Test ToothpasteToothpaste containing 5.0 % weight/weight (w/w) CSPS. | Device | Test Toothpaste |
| Regular Fluoride ToothpasteRegular fluoride toothpaste. | Other | Reference Toothpaste (Negative Control) |
Primary outcome
Change from Baseline in Schiff Sensitivity Score at Week 8
Time frame: Baseline and Week 8
Evaporative (air) sensitivity will be assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 3, where 0 equal to (=) Did not respond to air stimulation; 1= Responded to air stimulus but did not request discontinuation of stimulus; 2= Responded to air stimulus and requested discontinuation or moved from stimulus; 3= Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Week 8 score. Lower score indicates improvement.
3 secondary outcomes
Change from Baseline in Tactile Threshold gram (g) at Week 8
Time frame: Baseline and Week 8
Change from Baseline in Schiff Sensitivity Score at Weeks 2 and 4
Time frame: Baseline, Week 2 and Week 4
Change from Baseline in Tactile Threshold (g) at Weeks 2 and 4
Time frame: Baseline, Week 2 and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Toothpaste and Regular Fluoride Toothpaste in people with Dentin Sensitivity, run by HALEON at 1 site in United Kingdom.
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 16 inclusion and 36 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haleon Response Center (+441932 95 95 00, ww.clinical-trial-register@haleon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Schiff Sensitivity Score at Week 8 (time frame: Baseline and Week 8). 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 3 Sep 2026.