Enamel Lesion Detection With New DX Tool

NCT07819370 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: CRO-2025-CaseStudies-BC-GJ
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enamel Lesions; Caries

Outcome Measures

Primary Outcomes (1)

• Enamel Lesions per BlueCheck

  Number of enamel lesions counted after using BlueCheck

  Baseline, 4 weeks, and 12 weeks

Secondary Outcomes (4)

• Self-perceived reactions to BlueCheck application

  Baseline, 4 weeks, and 12 weeks

• Enamel Lesions per Xray

  Baseline, 4 weeks, and 12 weeks

• Enamel lesions per intraoral camera

  Baseline, 4 weeks, and 12 weeks

• White spots

  Baseline, 4 weeks, and 12 weeks

Study Arms (1)

Test Group

EXPERIMENTAL

This is a monadic study with one arm. All subjects will receive the intervention.

Device: BlueCheck; Drug: Prevident 5000ppm Booster Plus Toothpaste

Interventions

BlueCheck DEVICE

BlueCheck, a carious lesion detection formulated device, will be used to track enamel lesions for patients who are newly receiving a high fluoride toothpaste.

Test Group

Prevident 5000ppm Booster Plus Toothpaste DRUG

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

Test Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with fixed or removable orthodontic appliances or removable partial dentures.
• 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).

Sponsors & Collaborators

• Colgate Palmolive: lead
• Dental Dreams, LLC: collaborator

Study Sites (1)

Dental Dreams, LLC

Lithonia, Georgia, 30038, United States

Location

MeSH Terms

Interventions

Toothpastes

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Zerita Buchanan, DDS, MPH

CONTACT

404-289-7311; infopatient@dentaldreams.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 14, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)