A Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Effectiveness of Two Experimental Toothpastes

Exploratory Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Efficacy of Two Experimental Toothpastes

The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance.

This will be a single center, randomized, controlled, examiner-blind, 3-treatment arm, stratified (Baseline mean VITA Bleached Guide 3D-MASTER score), parallel design, clinical study in healthy participants, aged 18-65 years inclusive, with sufficient tooth discoloration/surface stain to evaluate the whitening potential of the experimental formulations, and self-reported/clinically diagnosed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be randomized to one of three study toothpastes. Approximately 105 qualifying participants will be stratified and randomized to study treatment (approximately 35 participants per treatment group).

Inclusion Criteria:

• Provision of signed and dated informed consent before any study procedures are performed.
• Participant is biologically male or female.
• Participant is 18 to 65 years of age, inclusive, at the time of signing the consent form.
• 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 (example, a medical condition confirmed to be causing xerostomia), 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 must have History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported) and must have good general oral health, with a minimum of 20 natural teeth.
• Participant must have minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants

Exclusion Criteria:

• Participant is an employee of the study site directly involved in the conduct of the study, or an employee of the study 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 (self-reported) or intending to become pregnant during the study (self-reported) or who is who is breastfeeding (self-reported).

• Participant with known or suspected intolerance or hypersensitivity to any of the study products (Acclimatization Toothpaste or study toothpastes), 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 an investigational product (IP) within 30 days of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study (self-reported).

• Participant has participated in a tooth sensitivity study within 8 weeks of Screening (Visit 1) (self-reported).

• Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-hypersensitivity oral care product within 8 weeks of Screening (Visit 1) (self-reported).

• Participant is currently using an oral care product primarily intended for tooth whitening benefits or has used such a product within 8 weeks of Screening (Visit 1) (self-reported).

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

• Participant is taking daily doses of medications/treatments (self-reported) which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).

• Participant is taking daily doses of a medication (self-reported) which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.

• Participant requires antibiotic prophylaxis for dental procedures (self-reported).

• Participant has had a tooth whitening procedure (professional or in-home treatment) within 12 months of Screening (Visit 1) (self-reported).

• Participant has had dental prophylaxis within 8 weeks of Screening (Visit 1) (self-reported).

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

• Participant has had scaling or root planing within 3 months of Screening (Visit 1) (self-reported).

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

• Participant with a tongue or lip piercing.

• Participant with, in the opinion of the investigator or medically qualified designee, evidence of gross intra-oral neglect or the need for extensive dental therapy.

• Participant with evidence of current/recent active dental caries or (self-reported) treatment for decay within 12 months of Screening (Visit 1).

• Participant with a fixed or removable partial prosthesis, multiple dental implants, fixed or removable orthodontic braces/bands and/or a fixed orthodontic retainer which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.

• Specific dentition exclusions: For eligible teeth (DH assessment)

  1. Tooth with evidence of current/recent caries.
  2. Tooth with treatment for decay within 12 months of Screening (Visit 1) (self-reported).
  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-hypersensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.

• Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1) (self-reported).

• Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the 2-week Acclimatization Period (self-reported).

• 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.