RemineralizationPhase 3REMINSITUNCT07625670
Clinical Study to Evaluate Remineralization Using an in Situ Model.
A Phase 3 study testing Fluoride toothpaste containing 750 ppm MFP in a Dical base, Fluoride toothpaste containing 1450 ppm MFP in a Dical base and Fluoride-free toothpaste in a Dical base in people with Remineralization and Enamel Lesions, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
This is a phase III clinical trial that aims to evaluate the enamel remineralization efficacy of three dentifrices on artificial caries lesions using an in situ model. The study involves 30 healthy volunteers, aged 18 to 70, who will participate in a randomized, triple-blind, three-period crossover design. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Remineralization, Enamel Lesions, Enamel Subsurface Lesion
- What is being tested?
- Fluoride toothpaste containing 750 ppm MFP in a Dical base, Fluoride toothpaste containing 1450 ppm MFP in a Dical base and Fluoride-free toothpaste in a Dical base
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2026to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study to Evaluate Enamel Remineralization Using Three Dentifrices in an in Situ Model.
This is a phase III clinical trial that aims to evaluate the enamel remineralization efficacy of three dentifrices on artificial caries lesions using an in situ model. The study involves 30 healthy volunteers, aged 18 to 70, who will participate in a randomized, triple-blind, three-period crossover design. Researchers will compare a 750 ppm MFP dentifrice against a 1450 ppm MFP positive control and a fluoride-free negative control to measure variations in mineral gain. Participants will wear a removable intraoral appliance containing human enamel blocks for three 14-day experimental phases. A 7-day washout period using will be implemented before and between each treatment phase.
Read the detailed description
This Phase III, randomized, single-center, triple-blind, crossover clinical study will evaluate the remineralization efficacy of three dentifrices on artificially induced initial enamel caries lesions. The research will involve 30 healthy participants aged 18 to 70 years who meet strict inclusion criteria. The experimental design will utilize an in situ model where participants will wear custom-made removable mandibular intraoral appliances containing four human enamel blocks with pre-formed artificial caries lesions. These lesions will be created laboratory-side using an acidified gel demineralization system before the blocks are mounted into the appliances.
The study will follow a nine-week timeline, divided into three 14-day experimental phases separated by 7-day washout periods to eliminate carryover effects, totaling 8 visits. During the treatment phases, subjects will be randomly assigned to a sequence of three test products: a test dentifrice with 750 ppm MFP, a positive control with 1450 ppm MFP, and a fluoride-free negative control. Each participant will receive a soft-bristle toothbrush and the assigned toothpastes.
The primary outcome will be the change in integrated mineral loss measured by transverse microradiography (TMR). Baseline mineral loss will be established from a slice of each block before intraoral exposure and compared to post-treatment analysis of the adjacent tissue. Secondary outcomes will include changes in lesion depth and fluorescence loss parameters assessed via Quantitative Light-induced Fluorescence (QLF).
Statistical analysis will be performed using a linear mixed-effects ANCOVA model to confirm the hypothesis that the 750 ppm MFP dentifrice promotes significantly greater remineralization than the negative control, with effects lower than or comparable to the high-fluoride positive control.
- Conditions
- Remineralization, Enamel Lesions, Enamel Subsurface Lesion
- Being tested
- Fluoride toothpaste containing 750 ppm MFP in a Dical base, Fluoride toothpaste containing 1450 ppm MFP in a Dical base, Fluoride-free toothpaste in a Dical base, Toothbrush
- Keywords
- enamel remineralization, transverse micro-radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride toothpaste containing 750 ppm MFP in a Dical baseDrug
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
Fluoride toothpaste containing 1450 ppm MFP in a Dical baseDrug
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
Fluoride-free toothpaste in a Dical baseDrug
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days
ToothbrushDevice
A commercially available adult soft bristle toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush Receives: Drug: Fluoride toothpaste containing 750 ppm MFP in a Dical base; Device: Toothbrush |
| Positive Control Group | Active comparator | Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush Receives: Drug: Fluoride toothpaste containing 1450 ppm MFP in a Dical base; Device: Toothbrush |
| Negative Control Group | Sham comparator | Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush Receives: Drug: Fluoride-free toothpaste in a Dical base; Device: Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in integrated mineral loss (Δz)
Integrated mineral loss (Δz) will be assessed by transverse microradiography (TMR). This outcome will evaluate the change from the baseline demineralized state (Δz0) to the post-treatment state (Δz1) to quantify the net mineral gain or loss.
Measured: 9 weeks
Secondary outcomes (4)
Change in lesion depth
Post-treatments lesion depth (LD) will be assessed by TMR. For each experimental phase, post-treatment values will be compared with corresponding baseline measurements to determine the extent of remineralization.
Measured: 9 weeks
Change from Baseline in Fluorescence Loss
Fluorescence loss ΔF, will be assessed by quantitative light-induced fluorescence (QLF) to measure the percentage loss of fluorescence intensity. The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
Measured: 9 weeks
Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks
Maximum fluorescence loss ΔFmax at the deepest point of the lesion will be assessed by quantitative light-induced fluorescence (QLF). The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
Measured: 9 weeks
Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks
Fluorescence loss volume (ΔQ) will be assessed by quantitative light-induced fluorescence (QLF). The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start3 Sep 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemineralizationStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a Phase III, randomized, single-center, crossover, triple-blind clinical study utilizing an intra-oral enamel remineralization in situ model. The design is divided into three 14-day experimental phases, each separated by a 7-day washout period. Participants will be randomly assigned to a sequence of three test products (750 ppm MFP, 1450 ppm MFP, or fluoride-free control) across totaling 8 clinical visits.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Paraíba
- Responsible party
- Sponsor
- Investigators
- Fábio Correia Sampaio, PhD, Principal investigator, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625670
- Sponsor's protocol ID
- CRO-2026-02-REMIN-BZ-CB
- Acronym
- REMINSITU
- Status last verified
- Oct 2026
- First submitted
- 14 May 2026
- Last updated
- 20 Oct 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Enamel Remineralization Using Three Dentifrices in an in Situ Model.
- ClinicalTrials.gov ID
- NCT07625670
- Acronym / sponsor ID
- REMINSITU / CRO-2026-02-REMIN-BZ-CB
- Conditions
- Remineralization, Enamel Lesions, Enamel Subsurface Lesion
- Keywords
- enamel remineralization, transverse micro-radiography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Paraíba
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Jun 2026 (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 phase III clinical trial that aims to evaluate the enamel remineralization efficacy of three dentifrices on artificial caries lesions using an in situ model. The study involves 30 healthy volunteers, aged 18 to 70, who will participate in a randomized, triple-blind, three-period crossover design. Researchers will compare a 750 ppm MFP dentifrice against a 1450 ppm MFP positive control and a fluoride-free negative control to measure variations in mineral gain. Participants will wear a removable intraoral appliance containing human enamel blocks for three 14-day experimental phases. A 7-day washout period using will be implemented before and between each treatment phase.
Detailed description
This Phase III, randomized, single-center, triple-blind, crossover clinical study will evaluate the remineralization efficacy of three dentifrices on artificially induced initial enamel caries lesions. The research will involve 30 healthy participants aged 18 to 70 years who meet strict inclusion criteria. The experimental design will utilize an in situ model where participants will wear custom-made removable mandibular intraoral appliances containing four human enamel blocks with pre-formed artificial caries lesions. These lesions will be created laboratory-side using an acidified gel demineralization system before the blocks are mounted into the appliances.
The study will follow a nine-week timeline, divided into three 14-day experimental phases separated by 7-day washout periods to eliminate carryover effects, totaling 8 visits. During the treatment phases, subjects will be randomly assigned to a sequence of three test products: a test dentifrice with 750 ppm MFP, a positive control with 1450 ppm MFP, and a fluoride-free negative control. Each participant will receive a soft-bristle toothbrush and the assigned toothpastes.
The primary outcome will be the change in integrated mineral loss measured by transverse microradiography (TMR). Baseline mineral loss will be established from a slice of each block before intraoral exposure and compared to post-treatment analysis of the adjacent tissue. Secondary outcomes will include changes in lesion depth and fluorescence loss parameters assessed via Quantitative Light-induced Fluorescence (QLF).
Statistical analysis will be performed using a linear mixed-effects ANCOVA model to confirm the hypothesis that the 750 ppm MFP dentifrice promotes significantly greater remineralization than the negative control, with effects lower than or comparable to the high-fluoride positive control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a Phase III, randomized, single-center, crossover, triple-blind clinical study utilizing an intra-oral enamel remineralization in situ model. The design is divided into three 14-day experimental phases, each separated by a 7-day washout period. Participants will be randomly assigned to a sequence of three test products (750 ppm MFP, 1450 ppm MFP, or fluoride-free control) across totaling 8 clinical visits.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Fluoride toothpaste containing 750 ppm MFP in a Dical base, Device: ToothbrushSubjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush |
| Positive Control Group | Active comparator | Drug: Fluoride toothpaste containing 1450 ppm MFP in a Dical base, Device: ToothbrushSubjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush |
| Negative Control Group | Sham comparator | Drug: Fluoride-free toothpaste in a Dical base, Device: ToothbrushSubjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (12 listed)
- 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;
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 toothpaste containing 750 ppm MFP in a Dical baseSubjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days | Drug | Test Group |
| Fluoride toothpaste containing 1450 ppm MFP in a Dical baseSubjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days | Drug | Positive Control Group |
| Fluoride-free toothpaste in a Dical baseSubjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days | Drug | Negative Control Group |
| ToothbrushA commercially available adult soft bristle toothbrush | Device | Negative Control Group, Positive Control Group, Test Group |
Primary outcome
Change in integrated mineral loss (Δz)
Time frame: 9 weeks
Integrated mineral loss (Δz) will be assessed by transverse microradiography (TMR). This outcome will evaluate the change from the baseline demineralized state (Δz0) to the post-treatment state (Δz1) to quantify the net mineral gain or loss.
4 secondary outcomes
Change in lesion depth
Time frame: 9 weeks
Change from Baseline in Fluorescence Loss
Time frame: 9 weeks
Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks
Time frame: 9 weeks
Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
Fábio Correia Sampaio, PhD principal investigator
Federal University of Paraíba
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 toothpaste containing 750 ppm MFP in a Dical base, Fluoride toothpaste containing 1450 ppm MFP in a Dical base and Fluoride-free toothpaste in a Dical base in people with Remineralization and Enamel Lesions, 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?
The sponsor lists 7 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in integrated mineral loss (Δz) (time frame: 9 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 20 Oct 2026.