Status:
RECRUITING
Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice
Lead Sponsor:
HALEON
Conditions:
Dentin Hypersensitivity
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief 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), compa...
Detailed Description
This will be a multi-center, randomized, controlled, double-blind, 4-treatment arm, stratified, parallel design, Phase III clinical study in healthy participants, aged 12-65 years inclusive, with self...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT07215767
Start Date
September 16 2025
End Date
July 1 2026
Last Update
November 4 2025
Active Locations (3)
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1
All Sum Research Limited
Melbourne, Florida, United States, 32935
2
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825
3
Silverstone Research
Las Vegas, Nevada, United States, 89146