Enamel LesionsPhase 4NCT07819370
Enamel Lesion Detection With New DX Tool
A Phase 4 study testing BlueCheck and Prevident 5000ppm Booster Plus Toothpaste in people with Enamel Lesions and Caries, run by Colgate Palmolive at 1 site in United States.
Trial summary
The primary objective of this 12-week study is to test BlueCheck's ability to identify enamel lesions consistently, and its ability to track changes in these lesions over time. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Enamel Lesions, Caries
- What is being tested?
- BlueCheck and Prevident 5000ppm Booster Plus Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 20 Dec 2026
- Phase
- Phase 4
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed Informed Consent/Assent Form.
- Male and female subjects aged 13 years or older.
- Availability for the duration of the study.
- Good general health and good oral health based on the opinion of the study investigator.
- Subjects must have active enamel lesions and no cavities requiring immediate restoration in the mouth.
- Subjects must be candidates for high fluoride toothpaste treatment.
Who cannot join
- Subjects with fixed or removable orthodontic appliances or removable partial dentures.
- Obvious signs of periodontal disease or any condition that the dental examiner considers exclusionary from the study.
- Cavities.
- Concurrent participation in another oral clinical study.
- Self-reported pregnant and/or lactating women, or those planning to become pregnant during the study.
- History of allergies or sensitivity to personal care consumer products or their ingredients.
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- Medical condition which requires premedication prior to dental visits/procedure.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- Dental prophylaxis within 30 days prior to study start.
- Subjects who must receive dental treatment during the study dates.
- Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1).
- Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dental Dreams, LLC
Lithonia, Georgia, 30038
Zerita Buchanan, DDS, MPH, 404-289-7311, infopatient@dentaldreams.net
Zerita Buchanan, DDS, MPH
About this study
Official title: Early Enamel Lesion Detection and Management With a New Diagnostic Tool
The primary objective of this 12-week study is to test BlueCheck's ability to identify enamel lesions consistently, and its ability to track changes in these lesions over time.
- Conditions
- Enamel Lesions, Caries
- Being tested
- BlueCheck, Prevident 5000ppm Booster Plus Toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueCheckDevice
BlueCheck, a carious lesion detection formulated device, will be used to track enamel lesions for patients who are newly receiving a high fluoride toothpaste.
Prevident 5000ppm Booster Plus ToothpasteDrug
This clinical study is testing the ability of BlueCheck to detect enamel lesions over time. In order to show changes in lesions, subjects will be prescribed Prevident 5000ppm Booster Plus Toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | This is a monadic study with one arm. All subjects will receive the intervention. Receives: Device: BlueCheck; Drug: Prevident 5000ppm Booster Plus Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel Lesions per BlueCheck
Number of enamel lesions counted after using BlueCheck
Measured: Baseline, 4 weeks, and 12 weeks
Secondary outcomes (4)
Self-perceived reactions to BlueCheck application
Questionnaire clinician and subject feedback on the BlueCheck application
Measured: Baseline, 4 weeks, and 12 weeks
Enamel Lesions per Xray
Number and location of visible enamel lesions on Xray
Measured: Baseline, 4 weeks, and 12 weeks
Enamel lesions per intraoral camera
Number and location of enamel lesions detected by an intraoral camera using a caries mode
Measured: Baseline, 4 weeks, and 12 weeks
White spots
Number and location of visible white spots per examiner's identification
Measured: Baseline, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dental Dreams, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819370
- Sponsor's protocol ID
- CRO-2025-CaseStudies-BC-GJ
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Enamel Lesion Detection and Management With a New Diagnostic Tool
- ClinicalTrials.gov ID
- NCT07819370
- Acronym / sponsor ID
- CRO-2025-CaseStudies-BC-GJ
- Conditions
- Enamel Lesions, Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Dental Dreams, LLC
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 14 Sep 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 primary objective of this 12-week study is to test BlueCheck's ability to identify enamel lesions consistently, and its ability to track changes in these lesions over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: BlueCheck, Drug: Prevident 5000ppm Booster Plus ToothpasteThis is a monadic study with one arm. All subjects will receive the intervention. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent/Assent Form.
- Male and female subjects aged 13 years or older.
- Availability for the duration of the study.
- Good general health and good oral health based on the opinion of the study investigator.
- Subjects must have active enamel lesions and no cavities requiring immediate restoration in the mouth.
Key exclusion criteria (14 listed)
- Subjects with fixed or removable orthodontic appliances or removable partial dentures.
- Obvious signs of periodontal disease or any condition that the dental examiner considers exclusionary from the study.
- Cavities.
- Concurrent participation in another oral clinical study.
- Self-reported pregnant and/or lactating women, or those planning 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 |
|---|---|---|
| BlueCheckBlueCheck, a carious lesion detection formulated device, will be used to track enamel lesions for patients who are newly receiving a high fluoride toothpaste. | Device | Test Group |
| Prevident 5000ppm Booster Plus ToothpasteThis clinical study is testing the ability of BlueCheck to detect enamel lesions over time. In order to show changes in lesions, subjects will be prescribed Prevident 5000ppm Booster Plus Toothpaste | Drug | Test Group |
Primary outcome
Enamel Lesions per BlueCheck
Time frame: Baseline, 4 weeks, and 12 weeks
Number of enamel lesions counted after using BlueCheck
4 secondary outcomes
Self-perceived reactions to BlueCheck application
Time frame: Baseline, 4 weeks, and 12 weeks
Enamel Lesions per Xray
Time frame: Baseline, 4 weeks, and 12 weeks
Enamel lesions per intraoral camera
Time frame: Baseline, 4 weeks, and 12 weeks
White spots
Time frame: Baseline, 4 weeks, and 12 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 14 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BlueCheck and Prevident 5000ppm Booster Plus Toothpaste in people with Enamel Lesions and Caries, 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Sep 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Zerita Buchanan, DDS, MPH (404-289-7311, infopatient@dentaldreams.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enamel Lesions per BlueCheck (time frame: Baseline, 4 weeks, and 12 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 14 Sep 2026.