An interventional study of Test Toothpaste and Regular Fluoride Toothpaste in Dentin Sensitivity, sponsored by HALEON. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by HALEON · Not applicable, Interventional, and Treatment
Among 21 studies in Dentin Sensitivity by HALEON — 3 open to participants now, 4 under way, none of them phase 3. Dentin Sensitivity · HALEON.
Among the 21 studies in Dentin Sensitivity by HALEON, this one is the 9th largest by planned enrollment of the 20 interventional ones, is one of 4 that started in 2026, is one of 18 with no phase, and was the 20th registered.
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 →3 of the 21 studies in Dentin Sensitivity by HALEON are open now, in 3 countries. Each count lists the studies.
Of the 18 Dentin Sensitivity studies recruiting now, 6 (33%) set no upper age limit and 11 (61%) stop at 75 or younger; 1 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 4 started in 2026.
Median enrollment 185 across the 20 interventional studies, 375 across the 1 observational. Of the 17 that completed or were terminated, 12 (71%) have results posted.
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.
4 of the studies in Dentin Sensitivity by HALEON that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07300540HALEONReal-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief | 2026-11 |
| NCT07894796HALEONA Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity | 2027-01 |
| NCT07337109HALEONA Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers | 2027-02 |
| NCT07802886HALEONA Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity | 2027-03 |
Among the 21 studies in Dentin Sensitivity by HALEON, from their registry updates:
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.
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).
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 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.
Device: Test Toothpaste
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.
Other: Regular Fluoride Toothpaste
Toothpaste containing 5.0 % weight/weight (w/w) CSPS.
Regular 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 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.
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= 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 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.
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= 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.
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.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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