RecruitingPhase 3NCT07215767

Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice


Sponsor

HALEON

Enrollment

850 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and potassium nitrate (KNO3) dentifrice (Investigational Product), compared to SnF2 only, KNO3 only and Vehicle dentifrices, after 8 weeks twice daily use.


Eligibility

Min Age: 12 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria15

  • 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.

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Interventions

DRUGStannous fluoride and Potassium nitrate Dentifrice

Fluoride dentifrice

DRUGStannous fluoride Dentifrice

Fluoride dentifrice

DRUGPotassium nitrate Dentifrice

Non-fluoride dentifrice

DRUGVehicle Dentifrice

Placebo dentifrice


Locations(3)

All Sum Research Limited

Melbourne, Florida, United States

Salus Research, Inc.

Fort Wayne, Indiana, United States

Silverstone Research

Las Vegas, Nevada, United States

View Full Details on ClinicalTrials.gov

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NCT07215767


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