Dental CariesNCT07419763
Intra Oral Appliance (IOA) Model Evaluating the Efficacy of Sensitive Toothpaste
A study testing Active Comparator and Test toothpaste in people with Dental Caries, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243%… 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 and Test toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 10 Jun 2025
- 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
- Adults ≥18 years
- Good general and oral health
- Normal unstimulated saliva flow (≥1.5 mL unstimulated saliva in 5 minutes)
- ≥16 teeth and functional maxillary dentition to support palatal appliance
- Agree to abstain from other oral care products and preventive dental procedures during study
- No advanced periodontal disease, no visible untreated caries
Show all 11Show fewer
- If female, not pregnant or breastfeeding (self-reported)
- No significant oral soft tissue pathology; no peri/oral piercings; no removable partial dentures
- No antibiotics or immunosuppressives within 30 days of screening
- No palatal torus; no medical condition that would interfere with safety
- No allergy or significant adverse events to impression materials, acrylics, or common oral product
Who cannot join
- Unable to tolerate appliance or comply with procedures
- Oral pathology that interferes with participation
- Use of fluoride toothpaste during washout periods
- Participation in another appliance study within the last 4 week
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 Appliance (IOA) Model Evaluating the Efficacy of Three Dentifrices on Enamel Lesion Remineralization
This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and enamel fluoride concentration.
Read the detailed description
This in situ intraoral appliance (IOA) model evaluates anticaries potential by exposing demineralized enamel specimens to oral conditions while allowing for ex vivo treatment assessments. Subjects wore acrylic palatal appliances containing four enamel specimens covered with steel gauze to promote plaque formation. Each of the three treatment periods lasted seven days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 5-day fluoride-free washout preceded each period. Post-treatment specimens were analyzed for %SMHR and enamel fluoride concentration.
- Conditions
- Dental Caries
- Being tested
- Negative Control Toothpaste, Active Comparator, Test 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 ToothpasteDrug
Fluoride-free toothpaste
Active ComparatorDrug
Commercially available fluoride toothpaste
Test toothpasteDrug
Investigational fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Negative Control Toothpaste | Placebo comparator | Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period. Receives: Drug: Negative Control Toothpaste |
| Comparator | Active comparator | Sodium fluoride dentifrice (0.243% sodium fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period. Receives: Drug: Active Comparator |
| Test Toothpaste | Experimental | Test dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate, and 20% sodium bicarbonate. Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period. Receives: Drug: Test 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 7-day test period (three periods total)
Enamel Fluoride Concentration (EFU)
Post-treatment enamel fluoride concentration (µg F/cm³)
Measured: End of each 7-day test period (three periods 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 start15 Apr 2025
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annahita Ghassemi, PhD, Study director, Church & Dwight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419763
- Sponsor's protocol ID
- ST-25-U04
- Status last verified
- Feb 2026
- First submitted
- 12 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; de-identified datasets or additional supporting documents will not 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 Appliance (IOA) Model Evaluating the Efficacy of Three Dentifrices on Enamel Lesion Remineralization
- ClinicalTrials.gov ID
- NCT07419763
- Acronym / sponsor ID
- ST-25-U04
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (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.
This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and enamel fluoride concentration.
Detailed description
This in situ intraoral appliance (IOA) model evaluates anticaries potential by exposing demineralized enamel specimens to oral conditions while allowing for ex vivo treatment assessments. Subjects wore acrylic palatal appliances containing four enamel specimens covered with steel gauze to promote plaque formation. Each of the three treatment periods lasted seven days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 5-day fluoride-free washout preceded each period. Post-treatment specimens were analyzed for %SMHR and enamel fluoride concentration.
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 ToothpasteFluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period. |
| Comparator | Active comparator | Drug: Active ComparatorSodium fluoride dentifrice (0.243% sodium fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period. |
| Test Toothpaste | Experimental | Drug: Test toothpasteTest dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate, and 20% sodium bicarbonate. Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults ≥18 years
- Good general and oral health
- Normal unstimulated saliva flow (≥1.5 mL unstimulated saliva in 5 minutes)
- ≥16 teeth and functional maxillary dentition to support palatal appliance
- Agree to abstain from other oral care products and preventive dental procedures during study
Key exclusion criteria (4 listed)
- Unable to tolerate appliance or comply with procedures
- Oral pathology that interferes with participation
- Use of fluoride toothpaste during washout periods
- Participation in another appliance study within the last 4 week
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 ToothpasteFluoride-free toothpaste | Drug | Negative Control Toothpaste |
| Active ComparatorCommercially available fluoride toothpaste | Drug | Comparator |
| Test toothpasteInvestigational fluoride toothpaste | Drug | Test Toothpaste |
Primary outcome
Percent Surface Microhardness Recovery (%SMHR)
Time frame: End of each 7-day test period (three periods total)
Enamel Fluoride Concentration (EFU)
Time frame: End of each 7-day test period (three periods total)
Post-treatment enamel fluoride concentration (µg F/cm³)
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; de-identified datasets or additional supporting documents will not 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 and Test 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 11 inclusion and 4 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 7-day test period (three periods 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.