A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching

Exclusion Criteria

• •Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
• •Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 60 days prior to study entry and/or during study participation.
• •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 investigational 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 who is pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
• •Participant with known or suspected intolerance or hypersensitivity to the study materials \[including the peroxide bleaching treatment\] (or closely related compounds) or any of their stated ingredients.
• •Participant who, in the opinion of the investigator or medically qualified designee, has a condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements or who should not participate in the study for other reasons.
• •Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
• •Participant with a recent history (within the last year) of alcohol or other substance abuse.
• •Participant with gross periodontal disease or who has had treatment for periodontal disease (including surgery) within 12 months of Screening or who has had scaling or root planning within 3 months of Screening.
• •Participant who has had a peroxide tooth bleaching procedure (either professionally dispensed or at-home \[including peroxide-containing dentifrices\]) within 12 months of Screening.
• •Participant who has had a dental prophylaxis within 8 weeks of screening.
• •Participant who has used tooth desensitizing treatment (for example dentifrice, mouthwash et cetera) within 2 weeks of screening.
• •Participant with a fixed or removable partial prosthesis, multiple dental implants or orthodontic braces/bands or fixed retainer or togue/lip piercing which, in the opinion of the investigator, could impact study outcomes.
• •During the study period, participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquillizers, antidepressants, mood-altering and anti-inflammatory drugs). Participant will be allowed to use analgesics ad hoc to manage pain.
• •Participant who has tooth abnormalities such as cracking or gross caries lesions that may, in the opinion of the investigator, impact the ability to evaluate tooth sensitivity.
• •Participant who has previously been enrolled in this study.