A brighter smile without fluoride? new trial tests whitening toothpaste against stains
NCT ID NCT07761715
First seen Aug 12, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study compares a non-fluoride whitening toothpaste to a standard fluoride toothpaste to see which better removes surface stains from teeth. About 100 adults will brush with one of the two toothpastes at home for four weeks. Researchers will measure tooth color changes using a standard stain index to determine if the whitening toothpaste improves whiteness more than the control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A non-fluoride whitening toothpaste with stain-removing properties
- What this could lead to
- If effective, this toothpaste could offer a simple, at-home way to brighten teeth and reduce surface stains without fluoride.
- What could go wrong
- The trial is small and short-term, and results may not reflect long-term whitening or work for everyone. Tooth sensitivity or gum irritation are possible with whitening products.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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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100 people
The number who actually took part.
- Started
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May 2026
- Finished
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Jun 2026
- 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 years and older
- 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 ≥18 years old, ambulatory, and ni 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 all study directions, and be available for all 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. * Have had dental prophylaxis within the past 18 months, but not within the past 3 months, and agree to 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 al whitening products and procedures for the duration of the study. * Drink stain-forming beverages 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 in 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, I, 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 you 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 ot 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.
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