Dental CariesNCT07419672
Intra Oral Application (IOA) Testing Study of a Stannous Toothpaste
A study testing Active Comparator Fluoride Treatment (0.454% SnF) and Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste) in people with Dental Caries, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
The primary objective of this crossover in-situ study is to determine the fluoride bioavailability and enamel remineralization potential of an experimental, placebo, and a positive control reference toothpaste. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Active Comparator Fluoride Treatment (0.454% SnF) and Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Therametric Technologies, Inc.
Noblesville, Indiana, 46060
About this study
Official title: Intra Oral Application (IOA) Testing Study of TheraBreath Toothpaste
The primary objective of this crossover in-situ study is to determine the fluoride bioavailability and enamel remineralization potential of an experimental, placebo, and a positive control reference toothpaste.
Read the detailed description
Each 9-day test period was preceded by a washout period of at least four days during which subjects used a fluoride-free toothpaste. The washout phase ensured removal of residual fluoride exposure prior to beginning the next assigned dentifrice treatment. Subjects remained in good oral health and compliance was verified at the start of each test period.
- Conditions
- Dental Caries
- Being tested
- Negative Control Treatment Slurry (Fluoride-Free), Active Comparator Fluoride Treatment (0.454% SnF), Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Control Treatment Slurry (Fluoride-Free)Drug
Fluoride-free toothpaste used with an intra-oral appliance (IOA) containing enamel specimens. Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA, followed by expectoration without rinsing. Used to provide a baseline reference for enamel fluoride uptake and remineralization outcomes in an IOA model.
Active Comparator Fluoride Treatment (0.454% SnF)Drug
Commercially available stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Serves as an established reference for promoting enamel fluoride uptake and surface remineralization in an IOA model.
Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)Drug
Investigational stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Intended to evaluate enamel fluoride uptake and remineralization performance versus negative control and active comparator treatments in an IOA model.
| Study group | Role | What they receive |
|---|---|---|
| Negative Control Toothpaste | Placebo comparator | Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a negative-control toothpaste and slurry that contains no active fluoride. This arm provides a baseline reference for evaluating enamel fluoride uptake and remineralization responses relative to the test and comparator treatments. Receives: Drug: Negative Control Treatment Slurry (Fluoride-Free) |
| Comparator | Active comparator | Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a commercially available fluoride toothpaste and slurry of known efficacy in promoting enamel fluoride uptake and surface remineralization. This arm serves as an established reference standard for evaluating the performance of the test formulation. Receives: Drug: Active Comparator Fluoride Treatment (0.454% SnF) |
| Test Toothpaste | Experimental | Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with the investigational fluoride toothpaste and slurry. This arm evaluates the ability of the test formulation to promote enamel fluoride uptake and remineralization relative to both the negative control and active comparator treatments. Receives: Drug: Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Surface Microhardness Recovery (%SMHR)
Measured: End of each 9-day test period (three test periods in total)
Post-treatment fluoride concentration (µg F/g enamel)
Measured: End of each 9-day test period (three test periods in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start12 Aug 2024
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therametrics
- Responsible party
- Sponsor
- Investigators
- Annahita Ghassemi, PhD, Study director, Church & Dwight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419672
- Sponsor's protocol ID
- ST-24-U43
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to share individual participant data (IPD) from this study. Summary results will be provided as required, but no de-identified datasets or additional supporting documents will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Oral Application (IOA) Testing Study of TheraBreath Toothpaste
- ClinicalTrials.gov ID
- NCT07419672
- Acronym / sponsor ID
- ST-24-U43
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therametrics
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this crossover in-situ study is to determine the fluoride bioavailability and enamel remineralization potential of an experimental, placebo, and a positive control reference toothpaste.
Detailed description
Each 9-day test period was preceded by a washout period of at least four days during which subjects used a fluoride-free toothpaste. The washout phase ensured removal of residual fluoride exposure prior to beginning the next assigned dentifrice treatment. Subjects remained in good oral health and compliance was verified at the start of each test period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control Toothpaste | Placebo comparator | Drug: Negative Control Treatment Slurry (Fluoride-Free)Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a negative-control toothpaste and slurry that contains no active fluoride. This arm provides a baseline reference for evaluating enamel fluoride uptake and remineralization responses relative to the test and comparator treatments. |
| Comparator | Active comparator | Drug: Active Comparator Fluoride Treatment (0.454% SnF)Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a commercially available fluoride toothpaste and slurry of known efficacy in promoting enamel fluoride uptake and surface remineralization. This arm serves as an established reference standard for evaluating the performance of the test formulation. |
| Test Toothpaste | Experimental | Drug: Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with the investigational fluoride toothpaste and slurry. This arm evaluates the ability of the test formulation to promote enamel fluoride uptake and remineralization relative to both the negative control and active comparator treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Control Treatment Slurry (Fluoride-Free)Fluoride-free toothpaste used with an intra-oral appliance (IOA) containing enamel specimens. Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA, followed by expectoration without rinsing. Used to provide a baseline reference for enamel fluoride uptake and remineralization outcomes in an IOA model. | Drug | Negative Control Toothpaste |
| Active Comparator Fluoride Treatment (0.454% SnF)Commercially available stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Serves as an established reference for promoting enamel fluoride uptake and surface remineralization in an IOA model. | Drug | Comparator |
| Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)Investigational stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Intended to evaluate enamel fluoride uptake and remineralization performance versus negative control and active comparator treatments in an IOA model. | Drug | Test Toothpaste |
Primary outcome
Percent Surface Microhardness Recovery (%SMHR)
Time frame: End of each 9-day test period (three test periods in total)
Post-treatment fluoride concentration (µg F/g enamel)
Time frame: End of each 9-day test period (three test periods in total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to share individual participant data (IPD) from this study. Summary results will be provided as required, but no de-identified datasets or additional supporting documents will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annahita Ghassemi, PhD study director
Church & Dwight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator Fluoride Treatment (0.454% SnF) and Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste) in people with Dental Caries, run by Church & Dwight Company, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Surface Microhardness Recovery (%SMHR) (time frame: End of each 9-day test period (three test periods in total)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.