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Clinical Trials in the USA / NCT07819370
Starting soon Phase 4

Enamel Lesion Detection With New DX Tool

NCT07819370 · tracked via the Priya Life Science USA tracker
Sponsor
Colgate Palmolive
Phase
Phase 4
Started
2026-09-15
Last updated
2026-09-14

Condition(s) studied

Enamel LesionsCaries

Investigational drug(s) / intervention(s)

BlueCheckPrevident 5000ppm Booster Plus Toothpaste

BlueCheck: 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 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

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dental Dreams, LLC Lithonia Georgia

More Colgate Palmolive trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07819370 on ClinicalTrials.gov ↗ ← All trials in the USA