New stannous fluoride + potassium nitrate toothpaste for sensitive teeth

Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice

This study will try a toothpaste that combines stannous fluoride and potassium nitrate to see if it reduces dentin hypersensitivity in people aged 12–65.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: HALEON (industry)
• Locations: 3 sites (Melbourne, Florida and 2 other locations)
• Trial ID: NCT07215767 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, controlled Phase 3 trial that compares a combination stannous fluoride (SnF2) + potassium nitrate (KNO3) dentifrice against SnF2-only, KNO3-only, and vehicle dentifrices. About 630 participants aged 12–65 with clinically confirmed dentin hypersensitivity will be stratified and randomized across four parallel arms. Participants will use the assigned dentifrice twice daily and undergo sensitivity assessments at screening, baseline, 3 days, 1 week, 2 weeks, 4 weeks and 8 weeks. The primary goal is to determine whether the combination product provides superior antihypersensitivity relief over 8 weeks of use.

Who should consider this trial

Good fit: Ideal candidates are people aged 12–65 with a 6-month to 10-year history of dentin hypersensitivity and at least two non-adjacent teeth with exposed dentin confirmed on exam.

Not a fit: People without exposed dentin, with sensitivity due to other untreated dental conditions, recent dental procedures, or who cannot attend study visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination toothpaste could provide faster or greater relief from dentin hypersensitivity than single-ingredient or placebo toothpastes.

How similar studies have performed: Both stannous fluoride and potassium nitrate have prior evidence of reducing sensitivity, though large Phase 3 data on combined SnF2+KNO3 formulations are more limited.

Eligibility criteria

Inclusion Criteria:

* Provision of signed and dated informed consent document (and assent document, if appropriate)
* Participant is biologically male or female.
* Participant is 12 to 65 years of age, inclusive, at the time of signing the consent/assent form.
* 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 well-being, 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 has a history of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
* Participant has a minimum of 2 non-adjacent teeth (incisors, canines or premolars), in different quadrants, with exposed dentin due to facial/cervical erosion, abrasion or gingival recession, and clinically confirmed dentin hypersensitivity to tactile and evaporative (air) stimuli at Screening and Baseline.

Exclusion Criteria:

* Female participant who is pregnant at Screening and Baseline, or is intending to become pregnant during the study.
* Female participant who is breastfeeding.
* Participant with known or suspected intolerance or hypersensitivity to any of the study products, any of their stated ingredients or closely related compounds.
* Participant is participating in, or has participated in, other studies (including non-medicinal studies) involving an Investigational Product within 30 days of Screening 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.
* Participant is currently using an oral care product indicated for dentin hypersensitivity relief or care of sensitive teeth or has used an antihypersensitivity oral care product within 8 weeks of Screening.
* 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.
* Participant has had professional tooth de-sensitising treatment within 8 weeks of Screening.
* Participant has had a tooth bleaching procedure within 8 weeks of Screening.
* Participant has had dental prophylaxis within 4 weeks of Screening.
* Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
* Participant with evidence of current/recent active dental caries or treatment for decay within 12 months of Screening.
* Participant who, in the opinion of the investigator or dentally qualified designee, is at high risk of dental caries.
* Participant with specific dentition exclusions for 'Test Teeth'.
* Participant has taken antibiotics in the 2 weeks prior to Screening or Baseline.

Where this trial is running

Melbourne, Florida and 2 other locations

• All Sum Research Limited — Melbourne, Florida, United States (RECRUITING)
• Salus Research, Inc. — Fort Wayne, Indiana, United States (RECRUITING)
• Silverstone Research — Las Vegas, Nevada, United States (RECRUITING)

Study contacts

• Principal investigator: Pejmon Amini — Silverstone Research
• Study coordinator: Haleon Response Center

Conditions: Dentin Hypersensitivity