Enamel LesionsPhase 3REPAIRNCT06732518
Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model
A Phase 3 study testing Fluoride Toothpaste, Fluoride free toothpaste in a chalk base and Fluoride free toothpaste in a PCC/RNCC base in people with Enamel Lesions and Demineralization, Tooth, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
Clinical study to evaluate the anti-cavity efficacy of three dentifrices using an intra-oral enamel Demineralization - Remineralization In-Situ Model. This is a Phase III, single-center, triple-blind with a 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
- Enamel Lesions, Demineralization, Tooth, Remineralization
- What is being tested?
- Fluoride Toothpaste, Fluoride free toothpaste in a chalk base and Fluoride free toothpaste in a PCC/RNCC base
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Mar 2025to 24 Apr 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
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.
About this study
Official title: Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model
Clinical study to evaluate the anti-cavity efficacy of three dentifrices using an intra-oral enamel Demineralization - Remineralization In-Situ Model. This is a Phase III, single-center, triple-blind with a crossover design. It involves 36 participants aged between 18 and 70, randomized into 3 different groups + a washout group, and spans 6 weeks.
Read the detailed description
This clinical study aims to evaluate the anti-cavity efficacy of dentifrices using an intra-oral enamel demineralization-remineralization in-situ model. It is a Phase III, randomized, triple-blind, crossover study involving 36 participants aged 18 to 70. Participants will use an intra-oral appliance with a steel mesh holding bovine enamel blocks, properly disinfected before using. Participants will be divided into three groups of treatment: 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 will be instructed to brush twice daily for 6 weeks. Additionally, between the treatment phases (5 days), 9-day washout phases will occur, during which participants will use a fluoride-free toothpaste in a PCC/RNCC base. Subjects will undergo baseline visit, visit 2 - washout I (9 days), visit 3 - treatment phase I (5 days), visit 4- washout II, visit 5- treatment phase II, visit 6 - washout III, visit 7 - treatment phase III, visit 8 - final visit. The primary outcome will be enamel microhardness, measured before and after treatment, to assess changes in microhardness. 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.
- Being tested
- Fluoride Toothpaste, Fluoride free toothpaste in a chalk base, Fluoride free toothpaste in a PCC/RNCC base, Toothbrush
- Keywords
- enamel demineralization-remineralization, fluoride toothpaste, enamel microhardness
- Medical subject headings
- Tooth Demineralization, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride ToothpasteDrug
Fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base
Fluoride free toothpaste in a chalk baseDrug
Fluoride free toothpaste in a chalk base with herbal ingredients
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 |
|---|---|---|
| Fluoride toothpaste | Experimental | 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 |
| Fluoride free toothpaste in a chalk base | Active comparator | 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 |
| Fluoride free toothpaste in a PCC/RNCC base | Active comparator | This is a negative control group in which 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 | Other | This is a washout group in which 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 measured response will be a change in indentation length in the intra-oral appliance before and after treatment for microhardness. The indentation length will be used to calculate a hardness value. The percentage of mineral loss on the bovine tooth enamel surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization.
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 posted13 Dec 2024
- Study start13 Mar 2025
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel LesionsStudies 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.
- 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 Silva, PhD, Principal investigator, Federal University of Alagoas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732518
- Sponsor's protocol ID
- CRO-2024-04-DEM-REM-BZ-BG
- Acronym
- REPAIR
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2024
- Last updated
- 6 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model
- ClinicalTrials.gov ID
- NCT06732518
- Acronym / sponsor ID
- REPAIR / CRO-2024-04-DEM-REM-BZ-BG
- Keywords
- enamel demineralization-remineralization, fluoride toothpaste, enamel microhardness
- 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
- 13 Mar 2025 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 13 Dec 2024 (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 efficacy of three dentifrices using an intra-oral enamel Demineralization - Remineralization In-Situ Model. This is a Phase III, single-center, triple-blind with a crossover design. It involves 36 participants aged between 18 and 70, randomized into 3 different groups + a washout group, and spans 6 weeks.
Detailed description
This clinical study aims to evaluate the anti-cavity efficacy of dentifrices using an intra-oral enamel demineralization-remineralization in-situ model. It is a Phase III, randomized, triple-blind, crossover study involving 36 participants aged 18 to 70. Participants will use an intra-oral appliance with a steel mesh holding bovine enamel blocks, properly disinfected before using. Participants will be divided into three groups of treatment: 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 will be instructed to brush twice daily for 6 weeks. Additionally, between the treatment phases (5 days), 9-day washout phases will occur, during which participants will use a fluoride-free toothpaste in a PCC/RNCC base. Subjects will undergo baseline visit, visit 2 - washout I (9 days), visit 3 - treatment phase I (5 days), visit 4- washout II, visit 5- treatment phase II, visit 6 - washout III, visit 7 - treatment phase III, visit 8 - final visit. The primary outcome will be enamel microhardness, measured before and after treatment, to assess changes in microhardness. 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.
| Arm | Type | Receives |
|---|---|---|
| Fluoride toothpaste | Experimental | 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 |
| Fluoride free toothpaste in a chalk base | Active comparator | 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 |
| Fluoride free toothpaste in a PCC/RNCC base | Active comparator | Drug: Fluoride free toothpaste in a PCC/RNCC base, Device: ToothbrushThis is a negative control group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush |
| Washout | Other | Drug: Fluoride free toothpaste in a PCC/RNCC base, Device: ToothbrushThis is a washout group in which 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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); Normal salivary flow;
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 ToothpasteFluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base | Drug | Fluoride toothpaste |
| Fluoride free toothpaste in a chalk baseFluoride free toothpaste in a chalk base with herbal ingredients | Drug | Fluoride free toothpaste in a chalk base |
| Fluoride free toothpaste in a PCC/RNCC baseFluoride free toothpaste in a PCC/RNCC base | Drug | Fluoride free toothpaste in a PCC/RNCC base, Washout |
| ToothbrushA commercially available adult soft bristle toothbrush | Device | Fluoride free toothpaste in a PCC/RNCC base, Fluoride free toothpaste in a chalk base, Fluoride toothpaste, Washout |
Primary outcome
Microhardness change
Time frame: 6 weeks
The primary measured response will be a change in indentation length in the intra-oral appliance before and after treatment for microhardness. The indentation length will be used to calculate a hardness value. The percentage of mineral loss on the bovine tooth enamel surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization.
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 Aug 2025.
- 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 Silva, 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 Toothpaste, Fluoride free toothpaste in a chalk base and Fluoride free toothpaste in a PCC/RNCC base in people with Enamel Lesions and Demineralization, Tooth, 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 6 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: finished, as of the sponsor's last update on 6 Aug 2025. 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. 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 Aug 2025.