CariesPhase 4NCT04763044
Evaluation of the Fluoride Dose Response Using In Situ Caries Model
A Phase 4 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
The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 21 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between 18 and 85 years of age;
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
- Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;
- Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture;
- Be in good medical and dental health with no active caries or periodontal disease (NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1);
- Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).
Who cannot join
- Currently being pregnant, intending to become pregnant during the study period, or breast feeding;
- Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
- Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
- Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
- Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
- Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Institute
Indianapolis, Indiana, 46202
About this study
Official title: Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model
The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
- Conditions
- Caries
- Being tested
- 0 ppm F, 250 ppm F as MFP, 1100 ppm as MFP, 2800 ppm F as MFP, 1100 ppm SnF2
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.
1100 ppm SnF2Drug
Each subject will be assigned to this treatment during the fifth period 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 |
| Period 5 | Other | 1100 ppm SnF2 toothpaste only Receives: Drug: 1100 ppm SnF2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel Fluoride Uptake (EFU)
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Measured: Evaluations will occur after 21 days of product use
Secondary outcomes (5)
Enamel Fluoride Uptake (EFU)
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Measured: Evaluations will occur after 7 days of product use
Percent Surface Microhardness (SMH)
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Measured: Evaluations will occur after 7 days of product use
Enamel Fluoride Uptake (EFU)
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Measured: Evaluations will occur after 14 days of product use
Percent Surface Microhardness (SMH)
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Measured: Evaluations will occur after 14 days of product use
Percent Surface Microhardness (SMH)
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Measured: Evaluations will occur after 21 days of product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 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
- NCT04763044
- Sponsor's protocol ID
- 2020154
- Status last verified
- Jun 2022
- First submitted
- 9 Feb 2021
- Last updated
- 19 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model
- ClinicalTrials.gov ID
- NCT04763044
- Acronym / sponsor ID
- 2020154
- Conditions
- Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 19 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| 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) |
| Period 5 | Other | Drug: 1100 ppm SnF21100 ppm SnF2 toothpaste only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be between 18 and 85 years of age;
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
- Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;
Key exclusion criteria (6 listed)
- Currently being pregnant, intending to become pregnant during the study period, or breast feeding;
- Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
- Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
- Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
- Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
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 |
| 1100 ppm SnF2Each subject will be assigned to this treatment during the fifth period for this crossover study. | Drug | Period 5 |
Primary outcome
Enamel Fluoride Uptake (EFU)
Time frame: Evaluations will occur after 21 days of product use
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
5 secondary outcomes
Enamel Fluoride Uptake (EFU)
Time frame: Evaluations will occur after 7 days of product use
Percent Surface Microhardness (SMH)
Time frame: Evaluations will occur after 7 days of product use
Enamel Fluoride Uptake (EFU)
Time frame: Evaluations will occur after 14 days of product use
Percent Surface Microhardness (SMH)
Time frame: Evaluations will occur after 14 days of product use
Percent Surface Microhardness (SMH)
Time frame: Evaluations will occur after 21 days of product use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 4 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 8 inclusion and 6 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 Jul 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enamel Fluoride Uptake (EFU) (time frame: Evaluations will occur after 21 days of product use). 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 Jul 2022.