The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening To… (NCT07219342) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
United States109 participantsStarted 2025-09-11
Plain-language summary
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be between the ages of 18 and 65, ambulatory, and in good general health as determined by the Study Examiner, based upon clinical observation and the Medical/Dental History.
* Be able to understand and sign the Informed Consent, complete a Medical History form, understand and comply with al study directions, and be available for al exam periods.
* Present with adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect) and continue to meet the inclusion criteria and not fall into the categories of exclusion during the period of the study.
* Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of ≥ 1.5 on the labial surfaces of at least 8 of 12 anterior teeth.
* Have a minimum of 16 natural teeth, including the four maxillary incisors.
* Have had dental prophylaxis within the past 18 months, but not within the past 3 months, and agree ot refrain from using al oral care products (other dentifrices and toothbrushes, dental floss and mouthwashes), other than their assigned product, for the duration of the study.
* Agree to refrain from using all whitening products and procedures for the duration of the study.
* Drink tea/coffee daily.
Exclusion Criteria:
* Have a history of serious medical conditions or transmittable diseases including but not limited to active hepatitis, heart irregularities, conditions requiring pre-medication for dental procedures, rheumatic heart disease, untreated diabetes mellitus, cirrhosis, leuk…