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A brighter smile without fluoride? new trial tests whitening toothpaste against stains

NCT ID NCT07761715

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

100 people

The number who actually took part.

Started

May 2026

Finished

Jun 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Tooth Discoloration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Salus Research, Inc.

    Fort Wayne, Indiana, 46825, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.