Dentin SensitivityNCT07352956
A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population
A study testing Test toothpaste and Sodium fluoride toothpaste in people with Dentin Sensitivity, run by HALEON at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of a 0.454 percent (%) weight/weight (w/w) stannous fluoride (SnF2) toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus and tactile stimulus after 28 and 56 days twice daily brushing. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Test toothpaste and Sodium fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2026to 6 Apr 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
- Participant is biologically male or female.
- Participant is 18 to 70 years of age at the time of signing the consent form.
- Participant is willing and able to comply with the study visit schedule, toothpaste usage instructions, lifestyle restrictions, and other study procedures.
- Participant is in good general, oral, and mental health, which 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.
- Participant who is willing to receive reminders of appointments and videos reminding them on the brushing instructions.
- Participant must have a self-reported history of tooth sensitivity lasting more than 6 months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently.
- Participant must be in general oral health, with a minimum of 20 natural teeth.
Who cannot join
- Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
- Participant who is participating in, or has participated in, other studies (including nonmedicinal studies) involving investigational product(s) within 8 weeks of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
- Participant who is participating in, or has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
- Participant who is using or has used an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1).
- Participant who has had a professional desensitizing treatment within 8 weeks of Screening (Visit 1).
- Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
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- Participant who is unwilling or unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol.
- Participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1), or those observed to rinse with water while brushing during the supervised brushing with the allocated toothpaste at screening (Visit 1) or baseline (Visit 2).
- Female participant who is pregnant or intending to become pregnant during the study (self-reported) or is breastfeeding.
- Participant with a recent history (within the last year) of alcohol and/or substance abuse.
- Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- Participant taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain.
- Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
- Examples of traditional herbal treatments include clove oil, olive oil or other treatments directly applied to the oral cavity for the treatment of oral health conditions.
- Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, may cause xerostomia.
- Participant who needs antibiotic prophylaxis for dental procedures.
- Participant who has taken antibiotics within 2 weeks of screening (Visit 1) and Baseline visit (Visit 2) (during the acclimatization period).
- Participant who has had a professional or self-applied tooth bleaching procedure within 8 weeks of Screening (Visit 1).
- Participant who has had dental prophylaxis within 4 weeks of Screening (Visit 1).
- Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1).
- Participant who has had scaling or root planning within 3 months of Screening (Visit 1).
- Participant with a tongue or lip piercing.
- Participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease.
- 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 medically qualified designee, would impact study outcomes.
- Participant with multiple dental implants which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
- Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
- Participant who is unable to provide appropriate responses to the VAS training exercise.
- Specific dentition exclusions for 'Test Teeth':
- Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening (Visit 1).
- Tooth with exposed dentin but with deep, defective or facial restorations.
- Tooth with full crown or veneer.
- Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
- Sensitive tooth with contributing aetiologies other than EAR to exposed dentine.
- Sensitive tooth, in the opinion of the investigator or medically qualified designee, not expected to respond to treatment with an anti-sensitivity toothpaste.
- Participant who had previously been enrolled in this study.
- Any participant who, in the opinion of the investigator or medically qualified designee, was not expected to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
West China School/Hospital of Stomatology, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: An 8-Week, Randomised, Controlled, Examiner-blind Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population
The purpose of this study is to evaluate the clinical efficacy of a 0.454 percent (%) weight/weight (w/w) stannous fluoride (SnF2) toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus and tactile stimulus after 28 and 56 days twice daily brushing.
Read the detailed description
This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70, with self-reported and clinically confirmed DH in a Chinese population in a study design as per the Chinese Ministry of Health (MOH) Guidance. Sufficient participants will be screened so that approximately 100 participants (50 per group) will be stratified according to the maximum baseline Schiff sensitivity score of their two 'Test Teeth' and randomized to ensure approximately 90 evaluable participants (45 per group) complete the study.
- Conditions
- Dentin Sensitivity
- Being tested
- Test toothpaste, Sodium 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 toothpasteDrug
A toothpaste containing 0.454% SnF2.
Sodium fluoride toothpasteDrug
A regular sodium fluoride toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Participants will be instructed to brush the two test teeth first, then the whole mouth (all teeth) for at least 1-timed minute, twice daily (morning and evening) for 8 weeks. After brushing, participants will rinse once with 10 milliliter (ml) water using the measuring cup provided. Receives: Drug: Test toothpaste |
| Control Toothpaste | Other | Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) for 8 weeks. After brushing, rinse once with 10 ml water using the measuring cup provided. Receives: Drug: Sodium 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 Day 56
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline= Score at Day 56 minus baseline score. A decrease in Schiff sensitivity score indicates an improvement.
Measured: Baseline and Day 56
Change From Baseline in Tactile Threshold (grams [g]) at Day 56
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= Score at Day 56 minus baseline score.
Measured: Baseline and Day 56
Secondary outcomes (5)
Change From Baseline in Schiff Sensitivity Score at Day 56 (Test versus [vs] Control Toothpaste)
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline= Score at Day 56 minus baseline score. A decrease in Schiff sensitivity score indicates an improvement.
Measured: Baseline and Day 56
Change From Baseline in Tactile Threshold (g) at Day 56 (Test vs Control Toothpaste)
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= Score at Day 56 minus baseline score.
Measured: Baseline and Day 56
Change From Baseline in Schiff Sensitivity Score at Day 28
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline= Score at Day 28 minus baseline score. A decrease in Schiff sensitivity score indicates an improvement.
Measured: Baseline and Day 28
Change From Baseline in Tactile Threshold (g) at Day 28
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= Score at Day 28 minus baseline score.
Measured: Baseline and Day 28
Change From Baseline in (Visual Analogue Scale) VAS Scores at Day 28 and 56
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Participants then rated the intensity of their response to the evaporative (air) stimulus using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No discomfort) to 100 mm (extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.
Measured: Baseline, Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start16 Jan 2026
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352956
- Sponsor's protocol ID
- 300265
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 14 Apr 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Randomised, Controlled, Examiner-blind Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population
- ClinicalTrials.gov ID
- NCT07352956
- Acronym / sponsor ID
- 300265
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 20 Jan 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 purpose of this study is to evaluate the clinical efficacy of a 0.454 percent (%) weight/weight (w/w) stannous fluoride (SnF2) toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus and tactile stimulus after 28 and 56 days twice daily brushing.
Detailed description
This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70, with self-reported and clinically confirmed DH in a Chinese population in a study design as per the Chinese Ministry of Health (MOH) Guidance. Sufficient participants will be screened so that approximately 100 participants (50 per group) will be stratified according to the maximum baseline Schiff sensitivity score of their two 'Test Teeth' and randomized to ensure approximately 90 evaluable participants (45 per group) complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Drug: Test toothpasteParticipants will be instructed to brush the two test teeth first, then the whole mouth (all teeth) for at least 1-timed minute, twice daily (morning and evening) for 8 weeks. After brushing, participants will rinse once with 10 milliliter (ml) water using the measuring cup provided. |
| Control Toothpaste | Other | Drug: Sodium fluoride toothpasteParticipants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) for 8 weeks. After brushing, rinse once with 10 ml water using the measuring cup provided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
- Participant is biologically male or female.
- Participant is 18 to 70 years of age at the time of signing the consent form.
- Participant is willing and able to comply with the study visit schedule, toothpaste usage instructions, lifestyle restrictions, and other study procedures.
- Participant is in good general, oral, and mental health, which 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.
Key exclusion criteria (37 listed)
- Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
- Participant who is participating in, or has participated in, other studies (including nonmedicinal studies) involving investigational product(s) within 8 weeks of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
- Participant who is participating in, or has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
- Participant who is using or has used an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1).
- Participant who has had a professional desensitizing treatment within 8 weeks of Screening (Visit 1).
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 toothpasteA toothpaste containing 0.454% SnF2. | Drug | Test Toothpaste |
| Sodium fluoride toothpasteA regular sodium fluoride toothpaste. | Drug | Control Toothpaste |
Primary outcome
Change From Baseline in Schiff Sensitivity Score at Day 56
Time frame: Baseline and Day 56
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline= Score at Day 56 minus baseline score. A decrease in Schiff sensitivity score indicates an improvement.
Change From Baseline in Tactile Threshold (grams [g]) at Day 56
Time frame: Baseline and Day 56
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= Score at Day 56 minus baseline score.
5 secondary outcomes
Change From Baseline in Schiff Sensitivity Score at Day 56 (Test versus [vs] Control Toothpaste)
Time frame: Baseline and Day 56
Change From Baseline in Tactile Threshold (g) at Day 56 (Test vs Control Toothpaste)
Time frame: Baseline and Day 56
Change From Baseline in Schiff Sensitivity Score at Day 28
Time frame: Baseline and Day 28
Change From Baseline in Tactile Threshold (g) at Day 28
Time frame: Baseline and Day 28
Change From Baseline in (Visual Analogue Scale) VAS Scores at Day 28 and 56
Time frame: Baseline, Day 28 and Day 56
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 14 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sodium fluoride toothpaste in people with Dentin Sensitivity, run by HALEON at 1 site in China.
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 8 inclusion and 37 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 14 Apr 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 China. 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. 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?
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 Day 56 (time frame: Baseline and Day 56). 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 14 Apr 2026.