A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

An 8-Week, Randomised, Controlled, Examiner-blind Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

The purpose of this study is to evaluate the clinical efficacy of a 0.454 percent (%) weight/weight (w/w) stannous fluoride (SnF2) toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus and tactile stimulus after 28 and 56 days twice daily brushing.

This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70, with self-reported and clinically confirmed DH in a Chinese population in a study design as per the Chinese Ministry of Health (MOH) Guidance. Sufficient participants will be screened so that approximately 100 participants (50 per group) will be stratified according to the maximum baseline Schiff sensitivity score of their two 'Test Teeth' and randomized to ensure approximately 90 evaluable participants (45 per group) complete the study.

Inclusion Criteria:

• Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
• Participant is biologically male or female.
• Participant is 18 to 70 years of age at the time of signing the consent form.
• Participant is willing and able to comply with the study visit schedule, toothpaste usage instructions, lifestyle restrictions, and other study procedures.
• Participant is in good general, oral, and mental health, which 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.
• Participant who is willing to receive reminders of appointments and videos reminding them on the brushing instructions.
• Participant must have a self-reported history of tooth sensitivity lasting more than 6 months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently.
• Participant must be in general oral health, with a minimum of 20 natural teeth.

Exclusion Criteria:

• Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.

• Participant who is participating in, or has participated in, other studies (including nonmedicinal studies) involving investigational product(s) within 8 weeks of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.

• Participant who is participating in, or has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).

• Participant who is using or has used an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1).

• Participant who has had a professional desensitizing treatment within 8 weeks of Screening (Visit 1).

• Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).

• Participant who is unwilling or unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol.

• Participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1), or those observed to rinse with water while brushing during the supervised brushing with the allocated toothpaste at screening (Visit 1) or baseline (Visit 2).

• Female participant who is pregnant or intending to become pregnant during the study (self-reported) or is breastfeeding.

• Participant with a recent history (within the last year) of alcohol and/or substance abuse.

• Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.

• Participant taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain.

  1. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
  2. Examples of traditional herbal treatments include clove oil, olive oil or other treatments directly applied to the oral cavity for the treatment of oral health conditions.

• Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, may cause xerostomia.

• Participant who needs antibiotic prophylaxis for dental procedures.

• Participant who has taken antibiotics within 2 weeks of screening (Visit 1) and Baseline visit (Visit 2) (during the acclimatization period).

• Participant who has had a professional or self-applied tooth bleaching procedure within 8 weeks of Screening (Visit 1).

• Participant who has had dental prophylaxis within 4 weeks of Screening (Visit 1).

• Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1).

• Participant who has had scaling or root planning within 3 months of Screening (Visit 1).

• Participant with a tongue or lip piercing.

• Participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease.

• Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.

• Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.

• Participant with multiple dental implants which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.

• Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.

• Participant who is unable to provide appropriate responses to the VAS training exercise.

• Specific dentition exclusions for 'Test Teeth':

  1. Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening (Visit 1).
  2. Tooth with exposed dentin but with deep, defective or facial restorations.
  3. Tooth with full crown or veneer.
  4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
  5. Sensitive tooth with contributing aetiologies other than EAR to exposed dentine.
  6. Sensitive tooth, in the opinion of the investigator or medically qualified designee, not expected to respond to treatment with an anti-sensitivity toothpaste.

• Participant who had previously been enrolled in this study.

• Any participant who, in the opinion of the investigator or medically qualified designee, was not expected to participate in the study.