DemineralizationPhase 3NCT07134231
Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model
A Phase 3 study testing Fluoride free toothpaste in a chalk base, Fluoride Toothpaste and Fluoride free toothpaste in a PCC/RNCC base in people with Demineralization and Remineralization, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
Clinical study to evaluate the anti-cavity effectiveness of three dentrifices using an intra-oral enamel Demineralization and Remineralization In-Situ Model. This is a six-week duration, Phase III, single-center, triple-blind crossover study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Demineralization, Remineralization, Dental Cavity
- What is being tested?
- Fluoride free toothpaste in a chalk base, Fluoride Toothpaste and Fluoride free toothpaste in a PCC/RNCC base
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Oct 2025to 11 Dec 2025
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Potential subjects must meet ALL of the following criteria:
- Males and females, between 18-70 years of age (inclusive);
- Informed Consent Form signed and availability for the duration of the study;
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history;
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars); Normal salivary flow;
- Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.
Exclusion Criteria: Potential subjects must NOT HAVE ANY of the following conditions:
- Oral pathology, chronic disease, or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
- Subject allergic to oral care products, personal care consumer products, or their ingredients;
- Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
- A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm;
- Five or more decayed, untreated dental sites (cavities);
- Current smokers and subjects with a history of alcohol or drug abuse;
- Dental work prevents wearing of the appliance or a reported need to wear a night guard.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Situ Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization-Remineralization Model
Clinical study to evaluate the anti-cavity effectiveness of three dentrifices using an intra-oral enamel Demineralization and Remineralization In-Situ Model. This is a six-week duration, Phase III, single-center, triple-blind crossover study. Thirty-six healthy adults will be randomly allocated to three groups for the treatment phases, which are interspersed with washout periods.
Read the detailed description
This Phase III, randomized, triple-blind, crossover study will assess the anti-cavity effectiveness of three different dentrifices. Thirty-six participants, aged 18-70, will use an intra-oral appliance. For six weeks, they will be divided into three treatment groups and instructed to brush twice daily with one of the following: one using a fluoride-free toothpaste with a chalk base and herbal ingredients, another using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base, and a negative control group using a fluoride-free toothpaste in a PCC/RNCC base. Each participant will receive a soft-bristle toothbrush and the toothpastes assigned.
Between each five-day treatment phase, participants will have a nine-day washout period, using a fluoride-free toothpaste in a PCC/RNCC base. The study's eight-visit schedule includes a baseline visit, three treatment phases, three washout periods interspersed between the treatment phases, and a final visit. The primary outcome will be the measurement of changes in enamel microhardness, with assessments taking place both before and after each treatment to determine the impact on the enamel. The expected outcome is the confirmation of the alternative hypothesis, which predicts a reduction in the percentage of mineral loss from the surface of bovine enamel after using dentifrices containing 1000 ppm MFP with 1.5% arginine or herbal ingredients for five days each, compared to the control group. The percentage of mineral loss on the tooth surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization. A two factor ANCOVA using the baseline as the covariate will be conducted to determine if a significant treatment effect exists. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants.
- Conditions
- Demineralization, Remineralization, Dental Cavity, Enamel Lesions
- Being tested
- Fluoride free toothpaste in a chalk base, Fluoride Toothpaste, Fluoride free toothpaste in a PCC/RNCC base, Toothbrush
- Keywords
- enamel mircrohardness, enamel demineralization-remineralization
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride free toothpaste in a chalk baseDrug
Fluoride free toothpaste in a chalk base with herbal ingredients
Fluoride ToothpasteDrug
Fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base
Fluoride free toothpaste in a PCC/RNCC baseDrug
Fluoride free toothpaste in a PCC/RNCC base
ToothbrushDevice
A commercially available adult soft bristle toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Subjects will brush using a fluoride free toothpaste in a chalk base with herbal ingredients and a soft bristle toothbrush Receives: Drug: Fluoride free toothpaste in a chalk base; Device: Toothbrush |
| Positive Control Group | Active comparator | Subjects will brush using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base and a soft bristle toothbrush Receives: Drug: Fluoride Toothpaste; Device: Toothbrush |
| Negative Control Group | Sham comparator | Subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush Receives: Drug: Fluoride free toothpaste in a PCC/RNCC base; Device: Toothbrush |
| Washout Group | Other | Subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush for 9 days, between the treatment phases. Receives: Drug: Fluoride free toothpaste in a PCC/RNCC base; Device: Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microhardness change
The primary outcome of this study will be the change in the hardness of an intra-oral appliance before and after treatment. It will be determined by measuring the length of an indentation made on the appliance, which in turn allows for the calculation of its hardness value. The effectiveness of the treatment in reducing enamel demineralization by quantifying the percentage of mineral loss relative to the baseline will also be assessed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start9 Oct 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DemineralizationStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe 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
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a Phase III, randomized, one-center, crossover group, triple blind, clinical study with an intra-oral enamel Demineralization - Remineralization In-Situ Model.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Alagoas
- Responsible party
- Sponsor
- Investigators
- Natanael Santos, PhD, Principal investigator, Federal University of Alagoas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134231
- Sponsor's protocol ID
- CRO-2025-08-DEMI-REMI-BZ-CB
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization-Remineralization Model
- ClinicalTrials.gov ID
- NCT07134231
- Acronym / sponsor ID
- CRO-2025-08-DEMI-REMI-BZ-CB
- Conditions
- Demineralization, Remineralization, Dental Cavity, Enamel Lesions
- Keywords
- enamel mircrohardness, enamel demineralization-remineralization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Alagoas
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 21 Aug 2025 (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.
Clinical study to evaluate the anti-cavity effectiveness of three dentrifices using an intra-oral enamel Demineralization and Remineralization In-Situ Model. This is a six-week duration, Phase III, single-center, triple-blind crossover study. Thirty-six healthy adults will be randomly allocated to three groups for the treatment phases, which are interspersed with washout periods.
Detailed description
This Phase III, randomized, triple-blind, crossover study will assess the anti-cavity effectiveness of three different dentrifices. Thirty-six participants, aged 18-70, will use an intra-oral appliance. For six weeks, they will be divided into three treatment groups and instructed to brush twice daily with one of the following: one using a fluoride-free toothpaste with a chalk base and herbal ingredients, another using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base, and a negative control group using a fluoride-free toothpaste in a PCC/RNCC base. Each participant will receive a soft-bristle toothbrush and the toothpastes assigned.
Between each five-day treatment phase, participants will have a nine-day washout period, using a fluoride-free toothpaste in a PCC/RNCC base. The study's eight-visit schedule includes a baseline visit, three treatment phases, three washout periods interspersed between the treatment phases, and a final visit. The primary outcome will be the measurement of changes in enamel microhardness, with assessments taking place both before and after each treatment to determine the impact on the enamel. The expected outcome is the confirmation of the alternative hypothesis, which predicts a reduction in the percentage of mineral loss from the surface of bovine enamel after using dentifrices containing 1000 ppm MFP with 1.5% arginine or herbal ingredients for five days each, compared to the control group. The percentage of mineral loss on the tooth surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization. A two factor ANCOVA using the baseline as the covariate will be conducted to determine if a significant treatment effect exists. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a Phase III, randomized, one-center, crossover group, triple blind, clinical study with an intra-oral enamel Demineralization - Remineralization In-Situ Model.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Fluoride free toothpaste in a chalk base, Device: ToothbrushSubjects will brush using a fluoride free toothpaste in a chalk base with herbal ingredients and a soft bristle toothbrush |
| Positive Control Group | Active comparator | Drug: Fluoride Toothpaste, Device: ToothbrushSubjects will brush using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base and a soft bristle toothbrush |
| Negative Control Group | Sham comparator | Drug: Fluoride free toothpaste in a PCC/RNCC base, Device: ToothbrushSubjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush |
| Washout Group | Other | Drug: Fluoride free toothpaste in a PCC/RNCC base, Device: ToothbrushSubjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush for 9 days, between the treatment phases. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fluoride free toothpaste in a chalk baseFluoride free toothpaste in a chalk base with herbal ingredients | Drug | Test Group |
| Fluoride ToothpasteFluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base | Drug | Positive Control Group |
| Fluoride free toothpaste in a PCC/RNCC baseFluoride free toothpaste in a PCC/RNCC base | Drug | Negative Control Group, Washout Group |
| ToothbrushA commercially available adult soft bristle toothbrush | Device | Negative Control Group, Positive Control Group, Test Group, Washout Group |
Primary outcome
Microhardness change
Time frame: 6 weeks
The primary outcome of this study will be the change in the hardness of an intra-oral appliance before and after treatment. It will be determined by measuring the length of an indentation made on the appliance, which in turn allows for the calculation of its hardness value. The effectiveness of the treatment in reducing enamel demineralization by quantifying the percentage of mineral loss relative to the baseline will also be assessed.
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 6 Feb 2026.
- 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.
Natanael Santos, PhD principal investigator
Federal University of Alagoas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride free toothpaste in a chalk base, Fluoride Toothpaste and Fluoride free toothpaste in a PCC/RNCC base in people with Demineralization and Remineralization, run by Colgate Palmolive at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Feb 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Microhardness change (time frame: 6 weeks). 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 6 Feb 2026.