Toothpaste showdown: can whitening paste beat fluoride for stain removal?
NCT ID NCT07219342
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests whether a non-fluoride whitening toothpaste can remove tooth stains better than a regular fluoride toothpaste that doesn't whiten. About 109 adults will use the toothpaste at home for 8 weeks. Researchers will measure tooth color and stain levels to see which product works better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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109 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, leukemia, phenylketonuria, renal disease, sarcoidosis, tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or idiosyncrasies, or any other medical condition that may preclude successful participation ni the trial, at the discretion of the Study Examiner. * Have had prior significant adverse effects following the use of oral hygiene products. * Have the presence of orthodontic bands, retainers, fixed appliances, large restorations, or removable partial dentures, which may interfere with clinical assessments of the evaluable teeth. * Show evidence of neglected dental health in need of prompt professional attention (i.e., gross calculus deposits or rampant caries), significant oral soft tissue pathology, systemically related gingival enlargement, generalized recession, tissue damage due to ill-fitting appliances or restorations, or extreme crowding or overlapping of teeth. Periodontitis (ADA Class I, III, or IV), e.g., more than two teeth with periodontal pockets \>4 mm as evidenced by purulent exudate, tooth mobility, and other signs indicating that the integrity of the data collected might be compromised. * Have medication therapy that is current and ongoing or within the past 4 weeks, which might interfere with the outcome of the study by affecting oral tissue condition, salivation, or stain formation (particularly chronic long-term medication therapy). * Are nursing (breast-feeding) or pregnant. * Present at baseline with any reported sensory reactions, observed gum irritation, or any condition that would interfere with subsequent clinical assessments, or subjects with a history of allergy to oral care products, severe oral cavity sensitivity, or excessive oral irritation. * Have participated in tooth bleaching or whitening dentifrice trials within the last three months. * Have had professional or at-home bleaching during the last 6 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Salus Research, Inc.
Fort Wayne, Indiana, 46825, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A brighter smile without fluoride? new trial tests whitening toothpaste against stains
- Could a gentler solution replace acid for brighter teeth?
- 3D-Printed veneers face off against prefabricated ones in dental beauty trial
- New toothpaste promises brighter smiles without fluoride
- New silver mouthwash could end Kids' battle with bad taste and stained teeth