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Toothpaste showdown: can TheraBreath beat cavities?

NCT ID NCT07419672

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether TheraBreath toothpaste helps prevent cavities by strengthening tooth enamel. 31 adults wore a dental appliance with enamel samples and used different toothpastes to compare how much fluoride was absorbed and how well enamel recovered. The goal was to see if TheraBreath works better than a placebo or a standard toothpaste.

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

31 people

The number who actually took part.

Started

Aug 2024

Finished

Nov 2024

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 of age or older, * have the ability to understand the information contained in the informed consent without the need for cognitive or language interpretation from any other person or source, * read and sign the Informed Consent and other necessary paperwork prior to initiation of study procedures, * be in good general and oral health based on medical/dental history, * have an existing useable dental appliance on file with the clinic or be willing to have one (1) or more dental impressions taken so that a dental appliance can be made to wear during the study, * have a sufficient functional maxillary dentition to support the palatal appliance, and overall the full (maxillary and mandibular) dentition must provide for proper mastication of food, no less than 16 teeth, * must be able to expectorate ≥ 1.5 ml of non-stimulated saliva over a 5-minute period\*, * be willing to refrain from using non-study mouthwash, dentifrice, gum, mints, and other non-study oral care products during the entire length of the study (exception: xylitol free gum and mints will be allowed during acclimation/washout periods only), * be willing to participate in the study, be able to follow the study directions, and be willing to return for all specified visits at their appointed time, * be willing to refrain from actively participating in another oral care, drug or medical device research study (participation in a marketing/opinion/behavioral study may be allowed so long as the Principal Investigator has provided permission to do so), * be willing and able to refrain from wearing a nightguard during testing periods (for nightguard wearers only), and * be willing to postpone all elective dental procedures, at the discretion of the Investigator/Designee, until the study has been completed. * Subjects who are unable to provide an adequate amount of saliva during the screening visit may be granted the opportunity to return to the dental clinic to try again (one time only) after adequate hydration. Exclusion Criteria: * advanced periodontal disease as characterized by purulent exudate, generalized mobility, etc., or undergoing active treatment for periodontitis, * pathologic lesions of the oral cavity (suspicious or confirmed; per Investigator/Designee discretion), * a medical condition that could be expected to interfere with the subject's safety during the study period, such as a true allergy to oral care product ingredients, including (but not limited to) artificial sweeteners, mint (peppermint, spearmint, etc.) or other artificial colors or flavorings, sodium fluoride, ingredients that are derived from seaweed or corn, etc., * full dentures, orthodontic appliances (with the exception of a lower, fixed retainer), or other oral devices/appliances or dental work which, at the discretion of the Investigator/Designee, would interfere with the fit of the dental appliance, * self-reported pregnancy, plans to become pregnant, or is currently breastfeeding, * allergy/adverse reaction to dental impression materials including Silicon Dioxide, Calcium Sulfate, Magnesium Oxide or Tetrasodium Pyrophosphate, * any decayed, untreated dental sites (cavities) (per Investigator/Designee discretion), * having taken antibiotic or immune-suppressive drugs within the past 30 days or anticipating the need to take antibiotic or immune-suppressive drugs during the course of the study (per Investigator/Designee discretion), * a medical history disclosing a medical condition that has been known to cause individuals to become severely immuno-compromised, or * a medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc. (per Investigator/Designee discretion).

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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

  • Therametric Technologies, Inc.

    Noblesville, Indiana, 46060, United States

More trials for these conditions

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