Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT07215767
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT07215767
Study Brief:
Protocol Section:
NCT07215767