Efficacy of Teeth Whitening Product Offerings in Adults

This is an interventional treatment trial for Tooth Discoloration focused on measuring Teeth whitening, Teeth bleaching, Tooth discoloration Read More

Inclusion Criteria:

• Provide written informed consent to participate in the study.
• Be 18 to 65 years of age.
• Agree not to participate in any other oral/dental product studies during the trial.
• Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed.
• Agree to refrain from the use of any other teeth whitening products once assigned to a treatment group.
• Agree to refrain from the use of any oral care products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
• Agree to return for all scheduled visits and follow study procedures.
• Be in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study.
• Have at least 4 gradable maxillary anterior teeth ( canine to canine) with a Vita Shade average score of C2 or darker.
• Be willing to refrain from consuming stain-causing food and beverages (i.e., coffee, tea, red wine, berries, etc.) during the initial treatment duration (treatment period excluding the 4 week follow up).
• Be a current or recent non-smoker (no smoking for at least 3 months).

Exclusion Criteria:

• Are undergoing treatment for gingivitis, periodontitis, or caries.
• Presence of self-reported tooth sensitivity.
• Present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
• Have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth ( canine to canine) or mandibular anterior teeth.
• Have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
• Present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
• Have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth.
• Have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypocalcification.
• Have any known allergies to over-the-counter oral hygiene/whitening products.
• Have any known allergies to the trial product ingredients.
• Are pregnant and/or breastfeeding.
• Are current smokers.