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Completed NCT07215767

Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice

Conditions: Dentin Hypersensitivity

Sex: All
Ages: 12 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 688
Sponsor: HALEON

Location: All Sum Research Limited Melbourne Florida

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07215767). StuddyBuddy aggregates publicly available trial information.