CariesNCT06140758
Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
A study testing Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice, Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice and Toms of Maine 0 ppm Fluoride Dentifrice in people with Caries, run by Procter and Gamble at 1 site in Australia.
Trial summary
The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice, Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice and Toms of Maine 0 ppm Fluoride Dentifrice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Jul 2023to 11 Dec 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18-75 years of age.
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form.
- Be in good general health based on medical/dental history and oral exam.
- Have no history of adverse or allergic reactions to tin or tin-containing products.
- Agree not to participate in any other oral study for the study duration.
- Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance.
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- Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time.
- Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study.
- Be willing to postpone all elective dental procedures until the study has been completed.
- Be willing to refrain from using calcium chews while using the test products.
- Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
- Ability to understand, and ability to read and sign, the informed consent form.
- Have at least 22 natural teeth.
- Have a gum-stimulated whole salivary flow rate ≥ 1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.
- Conditions
- Caries
- Being tested
- Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice, Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice, Toms of Maine 0 ppm Fluoride Dentifrice, Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice, 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) DentifriceDrug
Each subject will use this product during one of the six treatment periods in the crossover study design.
Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)DentifriceDrug
Each subject will use this product during one of the six treatment periods in the crossover study design.
Toms of Maine 0 ppm Fluoride DentifriceDrug
Each subject will use this product during one of the six treatment periods in the crossover study design.
Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) DentifriceDrug
Each subject will use this product during one of the six treatment periods in the crossover study design.
1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) DentifriceDrug
Each subject will use this product during one of the six treatment periods in the crossover study design.
1100 ppm (0.454% Stannous fluoride) DentifriceDrug
Each subject will use this product during one of the six treatment periods in the crossover study design.
| Study group | Role | What they receive |
|---|---|---|
| Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice | Active comparator | Not described Receives: Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice |
| Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice | Active comparator | Not described Receives: Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice |
| Toms of Maine 0 ppm Fluoride Dentifrice | Sham comparator | Not described Receives: Drug: Toms of Maine 0 ppm Fluoride Dentifrice |
| Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice | Active comparator | Not described Receives: Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice |
| 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice | Active comparator | Not described Receives: Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice |
| 1100 ppm (0.454% Stannous fluoride) Dentifrice | Active comparator | Not described Receives: Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineral Density
The percent mineral profile of each enamel/dentinel slab's demineralized control and remineralized/treated lesion, obtained from the microdensitometry analysis, will be compared with the median sound enamel percent mineral profile of the same section. A negative value indicates mineral has been lost and, therefore, the lesion has progressed, whereas a positive value indicates mineral has been gained and, therefore, the lesion has regressed.
Measured: 14 days
Scanning Electron Microscopy (SEM)
SEM imaging and SEM-EDS analysis will be conducted on TMR sections and whole sections of dentine lesions treated in situ to assess the occlusion of dentine tubules and distribution of elements within the lesions following the experiment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start31 Jul 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 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
- NCT06140758
- Sponsor's protocol ID
- 2022085
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
- ClinicalTrials.gov ID
- NCT06140758
- Acronym / sponsor ID
- 2022085
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 20 Nov 2023 (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 is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice | Active comparator | Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice |
| Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice | Active comparator | Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice |
| Toms of Maine 0 ppm Fluoride Dentifrice | Sham comparator | Drug: Toms of Maine 0 ppm Fluoride Dentifrice |
| Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice | Active comparator | Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice |
| 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice | Active comparator | Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice |
| 1100 ppm (0.454% Stannous fluoride) Dentifrice | Active comparator | Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be 18-75 years of age.
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form.
- Be in good general health based on medical/dental history and oral exam.
- Have no history of adverse or allergic reactions to tin or tin-containing products.
- Agree not to participate in any other oral study for the study duration.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) DentifriceEach subject will use this product during one of the six treatment periods in the crossover study design. | Drug | Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice |
| Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)DentifriceEach subject will use this product during one of the six treatment periods in the crossover study design. | Drug | Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice |
| Toms of Maine 0 ppm Fluoride DentifriceEach subject will use this product during one of the six treatment periods in the crossover study design. | Drug | Toms of Maine 0 ppm Fluoride Dentifrice |
| Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) DentifriceEach subject will use this product during one of the six treatment periods in the crossover study design. | Drug | Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice |
| 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) DentifriceEach subject will use this product during one of the six treatment periods in the crossover study design. | Drug | 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice |
| 1100 ppm (0.454% Stannous fluoride) DentifriceEach subject will use this product during one of the six treatment periods in the crossover study design. | Drug | 1100 ppm (0.454% Stannous fluoride) Dentifrice |
Primary outcome
Mineral Density
Time frame: 14 days
The percent mineral profile of each enamel/dentinel slab's demineralized control and remineralized/treated lesion, obtained from the microdensitometry analysis, will be compared with the median sound enamel percent mineral profile of the same section. A negative value indicates mineral has been lost and, therefore, the lesion has progressed, whereas a positive value indicates mineral has been gained and, therefore, the lesion has regressed.
Scanning Electron Microscopy (SEM)
Time frame: 14 days
SEM imaging and SEM-EDS analysis will be conducted on TMR sections and whole sections of dentine lesions treated in situ to assess the occlusion of dentine tubules and distribution of elements within the lesions following the experiment.
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 29 Feb 2024.
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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 study testing Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice, Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice and Toms of Maine 0 ppm Fluoride Dentifrice in people with Caries, run by Procter and Gamble at 1 site in Australia.
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 14 inclusion and 1 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 29 Feb 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 Australia. 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?
Mineral Density (time frame: 14 days). 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 29 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.