Toothpaste showdown: can TheraBreath beat cavities?
NCT ID NCT07419672
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.
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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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31 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Nov 2024
- 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 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
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Therametric Technologies, Inc.
Noblesville, Indiana, 46060, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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