CariesNCT06140745
Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial
A study testing 0 ppm Fluoride Dentifrice 1, 1100 ppm NaF Fluoride Dentifrice and 1500 ppm NaMFP Fluoride Dentifrice in people with Caries, run by Procter and Gamble at 1 site in Australia.
Trial summary
To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. 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?
- 0 ppm Fluoride Dentifrice 1, 1100 ppm NaF Fluoride Dentifrice and 1500 ppm NaMFP Fluoride Dentifrice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Oct 2020to 21 Feb 2021
- 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.
- Willingness to comply with all study procedures and be available for the duration of the study.
Who cannot join
- Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for periodontitis;
- A medical condition which requires premedication prior to dental visits/procedures;
- Untreated dental problems (e.g. cavities);
- Self-reported pregnancy or plans to become pregnant during the study;
- Existing dental work which prevents wearing of the appliance including orthodontic appliances or removable dentures;
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- Chronic disease such as diabetes or use of medications that cause gum swelling;
- Any diseases or conditions (including sensitivity to dentifrice ingredients or a history of allergic or adverse reactions to tin or tin-containing products) that might interfere with examination procedures or the participant safely completing the study;
- Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
- Use of drugs that may interact with the toothpaste slurries or which may affect salivary flow rate;
- History of health conditions requiring antibiotic coverage prior to dental treatment;
- Serious infectious disease;
- Any other medical or dental conditions deemed to put the health and wellbeing of the participant or research team at risk if the potential participant participated in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Experimental Dentifrice Formulations With Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind Randomized In-Situ Clinical Trial
To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. the % change in ΔZ values relative to ΔZd, will be the primary outcome measure.
- Conditions
- Caries
- Being tested
- 0 ppm Fluoride Dentifrice 1, 1100 ppm NaF Fluoride Dentifrice, 1500 ppm NaMFP Fluoride Dentifrice, 0 ppm Fluoride Dentifrice 2, 0 ppm Fluoride Dentifrice 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 ppm Fluoride Dentifrice 1Drug
Each subject will use this product during one of the five treatment periods in the crossover study design.
1100 ppm NaF Fluoride DentifriceDrug
Each subject will use this product during one of the five treatment periods in the crossover study design.
1500 ppm NaMFP Fluoride DentifriceDrug
Each subject will use this product during one of the five treatment periods in the crossover study design.
0 ppm Fluoride Dentifrice 2Drug
Each subject will use this product during one of the five treatment periods in the crossover study design.
0 ppm Fluoride Dentifrice 3Drug
Each subject will use this product during one of the five treatment periods in the crossover study design.
| Study group | Role | What they receive |
|---|---|---|
| 0 ppm Fluoride Dentifrice 1 | Placebo comparator | Not described Receives: Drug: 0 ppm Fluoride Dentifrice 1 |
| 1100 ppm NaF Fluoride Dentifrice | Active comparator | Not described Receives: Drug: 1100 ppm NaF Fluoride Dentifrice |
| 1500 ppm NaMFP Fluoride Dentifrice | Active comparator | Not described Receives: Drug: 1500 ppm NaMFP Fluoride Dentifrice |
| 0 ppm Fluoride Dentifrice 2 | Sham comparator | Not described Receives: Drug: 0 ppm Fluoride Dentifrice 2 |
| 0 ppm Fluoride Dentifrice 3 | Sham comparator | Not described Receives: Drug: 0 ppm Fluoride Dentifrice 3 |
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 start5 Oct 2020
- Primary completion21 Feb 2021
- Study completion21 Feb 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 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
- NCT06140745
- Sponsor's protocol ID
- 2019176
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 20 Nov 2023
- 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 20 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Experimental Dentifrice Formulations With Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind Randomized In-Situ Clinical Trial
- ClinicalTrials.gov ID
- NCT06140745
- Acronym / sponsor ID
- 2019176
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (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.
To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. the % change in ΔZ values relative to ΔZd, will be the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0 ppm Fluoride Dentifrice 1 | Placebo comparator | Drug: 0 ppm Fluoride Dentifrice 1 |
| 1100 ppm NaF Fluoride Dentifrice | Active comparator | Drug: 1100 ppm NaF Fluoride Dentifrice |
| 1500 ppm NaMFP Fluoride Dentifrice | Active comparator | Drug: 1500 ppm NaMFP Fluoride Dentifrice |
| 0 ppm Fluoride Dentifrice 2 | Sham comparator | Drug: 0 ppm Fluoride Dentifrice 2 |
| 0 ppm Fluoride Dentifrice 3 | Sham comparator | Drug: 0 ppm Fluoride Dentifrice 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 (13 listed)
- Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for periodontitis;
- A medical condition which requires premedication prior to dental visits/procedures;
- Untreated dental problems (e.g. cavities);
- Self-reported pregnancy or plans to become pregnant during the study;
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 Fluoride Dentifrice 1Each subject will use this product during one of the five treatment periods in the crossover study design. | Drug | 0 ppm Fluoride Dentifrice 1 |
| 1100 ppm NaF Fluoride DentifriceEach subject will use this product during one of the five treatment periods in the crossover study design. | Drug | 1100 ppm NaF Fluoride Dentifrice |
| 1500 ppm NaMFP Fluoride DentifriceEach subject will use this product during one of the five treatment periods in the crossover study design. | Drug | 1500 ppm NaMFP Fluoride Dentifrice |
| 0 ppm Fluoride Dentifrice 2Each subject will use this product during one of the five treatment periods in the crossover study design. | Drug | 0 ppm Fluoride Dentifrice 2 |
| 0 ppm Fluoride Dentifrice 3Each subject will use this product during one of the five treatment periods in the crossover study design. | Drug | 0 ppm Fluoride Dentifrice 3 |
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 20 Nov 2023.
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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 0 ppm Fluoride Dentifrice 1, 1100 ppm NaF Fluoride Dentifrice and 1500 ppm NaMFP 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 15 inclusion and 13 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 20 Nov 2023. 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 20 Nov 2023.