Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Toothpaste to relieve dentin hypersensitivity

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

Run by Haleon · NCT07894796 · Data updated 2026-11-12

This study tests whether a CSPS toothpaste can reduce dentin hypersensitivity after 8 weeks of twice-daily use, compared with a fluoride toothpaste in people with sensitive teeth.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment192 (estimated)
SponsorHaleon
Industry-sponsored
Locations1 site (Mississauga, Ontario)
StatusRecruiting
StartedOctober 19, 2026
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedOctober 30, 2026
Trial IDNCT07894796 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with a history of dentin hypersensitivity lasting more than six months and at least 20 natural teeth, willing to use study toothpaste twice daily for 8 weeks.

Probably not a fit

Participants whose dentin sensitivity is not responsive to CSPS toothpaste or who do not respond to the fluoride comparator may not experience a meaningful benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, parallel-group study comparing a calcium sodium phosphosilicate (CSPS) toothpaste to a regular sodium fluoride toothpaste. Adults with dentin hypersensitivity will use either toothpaste twice daily for 8 weeks. Approximately 192 participants will be randomized (about 96 per group) with about 172 completing the study. Dentin sensitivity will be measured in response to an evaporative (air) stimulus to assess efficacy. The trial is stratified by relevant baseline characteristics and follows standard safety and ethical procedures at a single site in Mississauga, Ontario.

Why it matters

Potential benefit: If successful, participants may experience reduced sensitivity to everyday triggers and improved comfort with daily activities involving warm, cold, or air exposure.

How similar studies have gone: Previous studies in this area have shown CSPS toothpaste can reduce hypersensitivity compared with fluoride products in similar study designs.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

1. History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
2. Good general oral health, with a minimum of 20 natural teeth.
3. Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:

   1. Exposed dentine due to facial/cervical erosion, abrasion, or gingival recession (EAR).
   2. Modified Gingival Index (MGI)= 0 directly adjacent to the exposed dentine \[that is (i.e.), the test area only\].
   3. Clinical mobility= 0.
   4. 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).

  1. Qualifying Tactile threshold \<= 20g at Screening and Baseline.
  2. Qualifying 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.

Exclusion Criteria:

* 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).
* 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), or participated in Haleon-sponsored study number 300100.
* 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 \[for example (e.g.), analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs\].
* Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1).
* Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), i.e., 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':

  1. Tooth with evidence of current/recent caries.
  2. Tooth with (self-reported) treatment for decay within 12 months of Screening (Visit 1).
  3. Tooth with exposed dentine and deep, defective, or facial restorations.
  4. Tooth with a full crown or veneer.
  5. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
  6. Sensitive tooth with contributing etiologies other than EAR to exposed dentine.
  7. 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.

Where it's running

  • All Sum Research Center Ltd.
    Mississauga, Ontario, Canada
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.