A Phase 4 interventional study of BlueCheck and Prevident 5000ppm Booster Plus Toothpaste in Enamel Lesions and Caries, sponsored by Colgate Palmolive. Not yet recruiting at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Colgate Palmolive · Phase 4, Interventional, and Diagnostic
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.
Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a monadic study with one arm. All subjects will receive the intervention.
Device: BlueCheck · Drug: Prevident 5000ppm Booster Plus Toothpaste
BlueCheck, a carious lesion detection formulated device, will be used to track enamel lesions for patients who are newly receiving a high fluoride toothpaste.
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
Enamel Lesions per BlueCheck
Number of enamel lesions counted after using BlueCheck
Time frame: Baseline, 4 weeks, and 12 weeks
Self-perceived reactions to BlueCheck application
Questionnaire clinician and subject feedback on the BlueCheck application
Time frame: Baseline, 4 weeks, and 12 weeks
Enamel Lesions per Xray
Number and location of visible enamel lesions on Xray
Time frame: 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
Time frame: Baseline, 4 weeks, and 12 weeks
White spots
Number and location of visible white spots per examiner's identification
Time frame: Baseline, 4 weeks, and 12 weeks
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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