An interventional study of Test Toothpaste and Regular Fluoride Toothpaste in Dentin Sensitivity, sponsored by HALEON. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by HALEON · Not applicable, Interventional, and Treatment
The aim of this study is to demonstrate the clinical efficacy of the Test Toothpaste containing Calcium Sodium Phosphosilicate (CSPS) in reducing Dentin Hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride Reference Toothpaste, after 8 Weeks of twice daily use.
This will be a single centre, 8-week, randomised, controlled, double-blind, 2-treatment arm, parallel group, stratified study in healthy participants with DH. Qualified participants will be randomised into one of two treatments; a 5 percent (%) 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).
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
This study's planned enrollment of 192 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Screening (Visit 1): Participant must have
Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:
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).
Exclusion Criteria:
Specific Dentition Exclusions for 'Test teeth':
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will brush their teeth with a full ribbon of Test Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening), for approximately 8 Weeks.
Other: Test Toothpaste
Participants will brush their teeth with a full ribbon of Reference Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening), for approximately 8 Weeks.
Other: Regular Fluoride Toothpaste
A toothpaste containing 5% weight/weight (w/w) CSPS.
A regular sodium fluoride toothpaste.
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 will range from 0 to 3, where 0 equal to (=) Participant 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 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.
Time frame: Baseline and Week 8
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 is average value for the two 'test teeth' identified at baseline. Change from Baseline is calculated by subtracting Baseline value from Week 8 value.
Time frame: 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 will range from 0 to 3, where 0= Participant 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 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.
Time frame: 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 is average value for the two 'test teeth' identified at baseline. Change from Baseline is calculated by subtracting Baseline value from Weeks 2 and 4 values.
Time frame: Baseline, Week 2 and Week 4
Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jan 2027, 3 months after the start.
Of 33 industry-sponsored interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's planned 3 months is close to that.
Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Apr 2027 → Jan 2027 and completion Apr 2027 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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