Dental CariesEarly Phase 1NCT05601154
Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses
A Early Phase 1 study testing Crest Cavity Protection toothpaste, Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse and Colgate PreviDent 5000+ toothpaste in people with Dental Caries, run by University of Michigan at 1 site in United States.
Trial summary
This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. 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?
- Crest Cavity Protection toothpaste, Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse and Colgate PreviDent 5000+ toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 28 Feb 2025
- Phase
- Early Phase 1
- 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
- Sign informed consent form
- Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study
- 18 years of age or older
- Good general health
- Good oral health, with no urgent treatment needs
- Normal salivary flow rate
Who cannot join
- Fail to understand or to agree to follow the study protocol
- Reduced salivary flow rate
- Poor general or oral health conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dentistry, University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses
This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.
- Conditions
- Dental Caries
- Being tested
- Crest Cavity Protection toothpaste, Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse, Colgate PreviDent 5000+ toothpaste, Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crest Cavity Protection toothpasteDrug
Also called Over-the-counter fluoride toothpaste followed by water rinse
Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds
Crest Cavity Protection toothpaste followed by Act Mint Fluoride RinseDrug
Also called Over-the-counter fluoride toothpaste followed by fluoride rinse
Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute
Colgate PreviDent 5000+ toothpasteDrug
Also called Prescription fluoride toothpaste followed by water rinse
Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds
Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride RinseDrug
Also called Prescription fluoride toothpaste followed by fluoride rinse
Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| Crest Cavity Protection | Active comparator | Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water Receives: Drug: Crest Cavity Protection toothpaste |
| Crest Cavity Protection followed by Act Mint Fluoride Rinse | Active comparator | Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm) Receives: Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse |
| Colgate PreviDent 5000+ | Active comparator | Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water Receives: Drug: Colgate PreviDent 5000+ toothpaste |
| Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse | Experimental | Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm) Receives: Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of fluoride bioavailability in saliva
Fluoride concentration in saliva will be measured before (baseline) and up to 60 min after the interventions, and the area under the curve of fluoride concentration versus time will be calculated to estimate bioavailability
Measured: 0 to 60 minutes after the interventions
Secondary outcomes (1)
Maximum fluoride concentration in saliva
From the area under the curve, the time at which the concentration in saliva is highest will be determined
Measured: 0 to 60 minutes after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start23 Mar 2023
- Primary completion4 Nov 2024
- Study completion28 Feb 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.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Tenuta, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601154
- Sponsor's protocol ID
- HUM00212598
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses
- ClinicalTrials.gov ID
- NCT05601154
- Acronym / sponsor ID
- HUM00212598
- Conditions
- Dental Caries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Nov 2022 (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 study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crest Cavity Protection | Active comparator | Drug: Crest Cavity Protection toothpasteCrest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water |
| Crest Cavity Protection followed by Act Mint Fluoride Rinse | Active comparator | Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride RinseCrest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm) |
| Colgate PreviDent 5000+ | Active comparator | Drug: Colgate PreviDent 5000+ toothpasteColgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water |
| Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse | Experimental | Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride RinseColgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign informed consent form
- Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study
- 18 years of age or older
- Good general health
- Good oral health, with no urgent treatment needs
Key exclusion criteria (3 listed)
- Fail to understand or to agree to follow the study protocol
- Reduced salivary flow rate
- Poor general or oral health conditions
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 |
|---|---|---|
| Crest Cavity Protection toothpasteAlso: Over-the-counter fluoride toothpaste followed by water rinseParticipants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds | Drug | Crest Cavity Protection |
| Crest Cavity Protection toothpaste followed by Act Mint Fluoride RinseAlso: Over-the-counter fluoride toothpaste followed by fluoride rinseParticipants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute | Drug | Crest Cavity Protection followed by Act Mint Fluoride Rinse |
| Colgate PreviDent 5000+ toothpasteAlso: Prescription fluoride toothpaste followed by water rinseParticipants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds | Drug | Colgate PreviDent 5000+ |
| Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride RinseAlso: Prescription fluoride toothpaste followed by fluoride rinseParticipants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute | Drug | Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse |
Primary outcome
Area under the curve of fluoride bioavailability in saliva
Time frame: 0 to 60 minutes after the interventions
Fluoride concentration in saliva will be measured before (baseline) and up to 60 min after the interventions, and the area under the curve of fluoride concentration versus time will be calculated to estimate bioavailability
1 secondary outcome
Maximum fluoride concentration in saliva
Time frame: 0 to 60 minutes after the interventions
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 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Crest Cavity Protection toothpaste, Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse and Colgate PreviDent 5000+ toothpaste in people with Dental Caries, run by University of Michigan 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 6 inclusion and 3 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 12 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Area under the curve of fluoride bioavailability in saliva (time frame: 0 to 60 minutes after the interventions). 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 12 Mar 2026.