Enamel ErosionPhase 3NCT07442136
Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion
A Phase 3 study testing New Toothpaste Containing SnF and Fluoride Toothpaste in people with Enamel Erosion, run by Colgate Palmolive at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a new toothpaste can prevent enamel erosion in healthy adults. Researchers will compare the test toothpaste to a control toothpaste to see if there is a difference in erosion levels. Participants will brush twice a day for two minutes with their assigned toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Erosion
- What is being tested?
- New Toothpaste Containing SnF and Fluoride Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to 1 Jun 2026
- 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
- Sign an Informed Consent Form;
- Male or female 18 to 70 years of age, inclusive;
- Be in good general health as determined by the study investigators;
- Available for the eighteen (18) days duration of the study;
- Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary saliva examination;
- Have healthy salivary pH (unstimulated saliva pH 6.8-7.8) ascertained from a preliminary saliva test;
- Must be able to accept a well-fitting removable intraoral appliance bearing at least two enamel specimens.
Who cannot join
- Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
- Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
- Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
- Obvious signs of dental erosion Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
- Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics, or medication which alters salivary flow
- Participation in any other oral clinical study for the duration of this study
Show all 9Show fewer
- Self-reported pregnancy and/or currently breastfeeding;
- Allergies to oral care products, personal care consumer products, and/or their ingredients;
- Medical condition which prohibits not eating/drinking for 4 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dentistry, University of Texas Health San Antonio
San Antonio, Texas, 78229
About this study
The goal of this clinical trial is to learn if a new toothpaste can prevent enamel erosion in healthy adults. Researchers will compare the test toothpaste to a control toothpaste to see if there is a difference in erosion levels. Participants will brush twice a day for two minutes with their assigned toothpaste.
Read the detailed description
The objective of this clinical study is to assess the efficacy of New Toothpaste Containing SnF as compared to commercially available toothpaste in the reduction of enamel erosion over a ten (10) days period. This investigation will be a randomized, double-blinded, single-center, parallel clinical study. Subjects will be randomly assigned to one of the two study groups, and will be instructed to use their assigned toothpaste for a period of ten (10) days.
- Conditions
- Enamel Erosion
- Being tested
- New Toothpaste Containing SnF, Fluoride Toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Toothpaste Containing SnFDrug
Participants will brush with a new toothpaste containing SnF for two minutes twice daily.
Fluoride ToothpasteDrug
Participants will brush with a regular fluoride toothpaste twice daily for two minutes.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Participants will brush with a new toothpaste Containing SnF for two minutes twice daily. Receives: Drug: New Toothpaste Containing SnF |
| Control | Placebo comparator | Participants will brush with a regular fluoride toothpaste for two minutes twice daily. Receives: Drug: Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface loss
Depth of surface loss in an enamel block worn on a dental retainer by the participant, as determined by an optical profilometer.
Measured: From baseline to the end of treatment at 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start3 Mar 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel ErosionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442136
- Sponsor's protocol ID
- CRO-2025-06-ERO-MS
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion
- ClinicalTrials.gov ID
- NCT07442136
- Acronym / sponsor ID
- CRO-2025-06-ERO-MS
- Conditions
- Enamel Erosion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Mar 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.
The goal of this clinical trial is to learn if a new toothpaste can prevent enamel erosion in healthy adults. Researchers will compare the test toothpaste to a control toothpaste to see if there is a difference in erosion levels. Participants will brush twice a day for two minutes with their assigned toothpaste.
Detailed description
The objective of this clinical study is to assess the efficacy of New Toothpaste Containing SnF as compared to commercially available toothpaste in the reduction of enamel erosion over a ten (10) days period. This investigation will be a randomized, double-blinded, single-center, parallel clinical study. Subjects will be randomly assigned to one of the two study groups, and will be instructed to use their assigned toothpaste for a period of ten (10) days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: New Toothpaste Containing SnFParticipants will brush with a new toothpaste Containing SnF for two minutes twice daily. |
| Control | Placebo comparator | Drug: Fluoride ToothpasteParticipants will brush with a regular fluoride toothpaste for two minutes twice daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sign an Informed Consent Form;
- Male or female 18 to 70 years of age, inclusive;
- Be in good general health as determined by the study investigators;
- Available for the eighteen (18) days duration of the study;
- Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary saliva examination;
Key exclusion criteria (9 listed)
- Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
- Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
- Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
- Obvious signs of dental erosion Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
- Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics, or medication which alters salivary flow
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 |
|---|---|---|
| New Toothpaste Containing SnFParticipants will brush with a new toothpaste containing SnF for two minutes twice daily. | Drug | Test |
| Fluoride ToothpasteParticipants will brush with a regular fluoride toothpaste twice daily for two minutes. | Drug | Control |
Primary outcome
Surface loss
Time frame: From baseline to the end of treatment at 10 days.
Depth of surface loss in an enamel block worn on a dental retainer by the participant, as determined by an optical profilometer.
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 17 Jul 2026.
- Individual participant dataSharing planned: No
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Recruiting
Hydroxyapatite Toothpastes and Enamel Remineralization:
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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 Phase 3 study testing New Toothpaste Containing SnF and Fluoride Toothpaste in people with Enamel Erosion, run by Colgate Palmolive at 1 site in United States.
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 9 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 17 Jul 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 United States. 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?
Surface loss (time frame: From baseline to the end of treatment at 10 days.). 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 17 Jul 2026.