A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers

Inclusion Criteria

• Participant provision of signed and dated informed consent before any study procedures are performed.
• Participant is male or female.
• Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent.
• Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
• 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 wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
• Screening (visit 1): Participant must have
• History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
• Good general oral health, with a minimum of 20 natural teeth.
• Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:
• Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
• Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).
• Clinical mobility = 0
• Clinically confirmed DH to both tactile and evaporative (air) stimuli: a) Qualifying tactile threshold less than or equal to ( =) 2.
• Baseline (Visit 2, Pre-Treatment): Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both screening (Visit 1) and baseline (Visit 2). a) Qualifying tactile threshold = 2 at screening and baseline.

Exclusion Criteria

• Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
• Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
• Female participant who is pregnant or intending to become pregnant during the study (self-reported).
• Female participant who is breastfeeding (self-reported).
• Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
• Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
• Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of screening (Visit 1) 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 (Visit 1).
• Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of screening (Visit 1). Participants will be required to bring their current oral care products to screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text.
• 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 (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
• Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to screening (Visit 1).
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