A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers

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

The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.

This will be a single center, 8-week, randomized, controlled, examiner-blind, 2-treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected 'test teeth') clinical study to evaluate the anti-sensitivity efficacy of a 0.454% SnF2 toothpaste in healthy participants with DH. The clinical efficacy of the 0.454% SnF2 toothpaste (test toothpaste) will be compared with that of a reference toothpaste, a commercially available, regular fluoride toothpaste with no known anti-sensitivity properties (negative control). Sufficient participants will be screened to randomize approximately 110 participants to investigational product (approximately 55 per treatment group) and to ensure approximately 100 evaluable participants complete the entire study (approximately 50 per treatment group).

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

  1. History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).

  2. Good general oral health, with a minimum of 20 natural teeth.

  3. Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:

     1. Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
     2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).
     3. Clinical mobility = 0
     4. Clinically confirmed DH to both tactile and evaporative (air) stimuli: A. Qualifying tactile threshold less than or equal to (<=) 20g. B. Qualifying Schiff sensitivity score more 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).

  1. Qualifying tactile threshold <= 20g at Screening and Baseline.
  2. Qualifying Schiff sensitivity score >= 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).

• Baseline (Visit 2, Pre-treatment): Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the acclimatization period.

• Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.

• Participant requires antibiotic prophylaxis for dental procedures.

• Participant has had professional tooth de-sensitising treatment within 8 weeks of Screening (Visit 1).

• Participant has had a tooth bleaching procedure within 8 weeks of Screening (Visit 1).

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

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

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

• Participant with gross periodontal disease.

• Participant with a tongue or lip piercing.

• 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 dentally qualified designee, could impact study outcomes.

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

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

• Specific dentition exclusions for 'Test teeth':

  1. Tooth with evidence of current/recent caries.
  2. Tooth with (self-reported) treatment for decay within 12 months of Screening (Visit 1).
  3. Tooth with exposed dentin and deep, defective or facial restorations.
  4. Tooth with a full crown or veneer.
  5. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
  6. Sensitive tooth with contributing etiologies other than EAR to exposed dentin.
  7. Sensitive tooth not expected to benefit from use of an anti-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.

• Participant who, in the opinion of the investigator or designee, is unable to provide appropriate responses to the Labelled Magnitude Scale (LMS) training questions.

• Participant has previously been enrolled in this study.

• Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.