CariesPhase 1NCT06735235
Salivary Fluoride Clearance
A Phase 1 study testing 0 ppm F, 250 ppm F as MFP and 1100 ppm as MFP in people with Caries, run by Procter and Gamble at 1 site in United States.
Trial summary
This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- 0 ppm F, 250 ppm F as MFP and 1100 ppm as MFP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 29 Jul 2021
- Phase
- 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
- Be at least 18 years of age;
- Provide written informed consent prior to study participation and be given a signed copy of the Informed Consent form;
- Be in good general health as determined by the Investigator/Designee based on a review of their medical history;
- Have at least 16 natural teeth;
- Have normal salivary flow (0.3-0.6 ml/min) or deemed acceptable by the Investigator/Designee as determined in a previous screening outside of this protocol;
- Agree not to participate in any other oral care studies for the duration of this study;
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- Agree not to change their current oral care routine except 1) to refrain from using mouth rinse and 2) to agree to use study washout product as designated (current floss users are permitted to continue to floss during this study); viii. Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
- Agree to refrain from eating, using breath mints, using medicated lozenges, chewing gum, brushing their teeth or drinking within 2 hours of the visit, other than small sips of water up to 30 minutes prior to the visit;
- Agree to refrain from drinking tea or mineral water, and/or eating sardines within the 12 hours prior to the study visit; and
- Agree to return for all scheduled visits and to follow all study procedures.
Who cannot join
- Active treatment for gingivitis, periodontitis, or caries;
- Self-reported pregnancy or nursing;
- Smoking or tobacco chewing;
- Sjögren syndrome or any other disease/condition causing severe xerostomia;
- Kidney disease or renal impairment;
- Undergoing chemotherapy or irradiation procedures;
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- Fixed orthodontic appliances that may interfere with product use;
- Inability to undergo any study procedures; or
- Any condition or disease, as determined by the Investigator/Designee that could be expected to interfere with examination procedures or with the subject's safe completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Salivary Fluoride Clearance Following the Use of Three MFP-Containing Dentifrices
This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Subjects will provide saliva samples at baseline and at 2, 6, 12, and 30 minutes post-treatment. The F- concentrations in each saliva sample will be determined by ion chromatography
- Conditions
- Caries
- Being tested
- 0 ppm F, 250 ppm F as MFP, 1100 ppm as MFP, 2800 ppm F as MFP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 ppm FDrug
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFPDrug
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFPDrug
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFPDrug
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) Receives: Drug: 0 ppm F; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP |
| Period 2 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) Receives: Drug: 0 ppm F; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP |
| Period 3 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) Receives: Drug: 0 ppm F; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP |
| Period 4 | Other | 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) Receives: Drug: 0 ppm F; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve (AUC)
The primary endpoint will be AUC of the fluoride levels from 2 to 30 minutes. AUC will be calculated for each subject and treatment combination by integrating a 3 parameter first order decay model curve estimate (y= theta1 * exp (-theta2.X) + theta3). For any values obtained for a timepoint that are below the detection limit, 0.5 times the detection limit will be used. The following rules will apply if a subject has missing value(s) before the AUC is calculated:
- If 2 or more timepoints are missing within a period, then the AUC will be set to missing
- If only 2-minute data are missing, then curve will be estimated as above
- If 6-minute or 12-minute data are missing, a linear imputation between the adjacent timepoints will be used
- If 30-minute data are missing, the 12-minute data will be carried forward.
Measured: 2-minutes, 6-minutes, 12-minutes, and 30-minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start14 Jul 2021
- Primary completion29 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735235
- Sponsor's protocol ID
- 2021061
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary Fluoride Clearance Following the Use of Three MFP-Containing Dentifrices
- ClinicalTrials.gov ID
- NCT06735235
- Acronym / sponsor ID
- 2021061
- Conditions
- Caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 16 Dec 2024 (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 is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Subjects will provide saliva samples at baseline and at 2, 6, 12, and 30 minutes post-treatment. The F- concentrations in each saliva sample will be determined by ion chromatography
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Other | Drug: 0 ppm F, Drug: 250 ppm F as MFP, Drug: 1100 ppm as MFP, Drug: 2800 ppm F as MFP0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
| Period 2 | Other | Drug: 0 ppm F, Drug: 250 ppm F as MFP, Drug: 1100 ppm as MFP, Drug: 2800 ppm F as MFP0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
| Period 3 | Other | Drug: 0 ppm F, Drug: 250 ppm F as MFP, Drug: 1100 ppm as MFP, Drug: 2800 ppm F as MFP0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
| Period 4 | Other | Drug: 0 ppm F, Drug: 250 ppm F as MFP, Drug: 1100 ppm as MFP, Drug: 2800 ppm F as MFP0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be at least 18 years of age;
- Provide written informed consent prior to study participation and be given a signed copy of the Informed Consent form;
- Be in good general health as determined by the Investigator/Designee based on a review of their medical history;
- Have at least 16 natural teeth;
- Have normal salivary flow (0.3-0.6 ml/min) or deemed acceptable by the Investigator/Designee as determined in a previous screening outside of this protocol;
Key exclusion criteria (9 listed)
- Active treatment for gingivitis, periodontitis, or caries;
- Self-reported pregnancy or nursing;
- Smoking or tobacco chewing;
- Sjögren syndrome or any other disease/condition causing severe xerostomia;
- Kidney disease or renal impairment;
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 |
|---|---|---|
| 0 ppm FEach subject will be randomly assigned to this treatment during one of the four periods for this crossover study. | Drug | Period 1, Period 2, Period 3, Period 4 |
| 250 ppm F as MFPEach subject will be randomly assigned to this treatment during one of the four periods for this crossover study. | Drug | Period 1, Period 2, Period 3, Period 4 |
| 1100 ppm as MFPEach subject will be randomly assigned to this treatment during one of the four periods for this crossover study. | Drug | Period 1, Period 2, Period 3, Period 4 |
| 2800 ppm F as MFPEach subject will be randomly assigned to this treatment during one of the four periods for this crossover study. | Drug | Period 1, Period 2, Period 3, Period 4 |
Primary outcome
area under the curve (AUC)
Time frame: 2-minutes, 6-minutes, 12-minutes, and 30-minutes
The primary endpoint will be AUC of the fluoride levels from 2 to 30 minutes. AUC will be calculated for each subject and treatment combination by integrating a 3 parameter first order decay model curve estimate (y= theta1 * exp (-theta2.X) + theta3). For any values obtained for a timepoint that are below the detection limit, 0.5 times the detection limit will be used. The following rules will apply if a subject has missing value(s) before the AUC is calculated: * If 2 or more timepoints are missing within a period, then the AUC will be set to missing * If only 2-minute data are missing, then curve will be estimated as above * If 6-minute or 12-minute data are missing, a linear imputation between the adjacent timepoints will be used * If 30-minute data are missing, the 12-minute data will be carried forward.
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 16 Dec 2024.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing 0 ppm F, 250 ppm F as MFP and 1100 ppm as MFP in people with Caries, run by Procter and Gamble 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 10 inclusion and 9 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 16 Dec 2024. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (AUC) (time frame: 2-minutes, 6-minutes, 12-minutes, and 30-minutes). 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 16 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.