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Clinical Trials/NCT07819370
NCT07819370Not yet recruitingPhase 4

Early Enamel Lesion Detection and Management With a New Diagnostic Tool

Colgate Palmolive1 site in 1 country5 target enrollmentStarted: September 15, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
5
Locations
1
Primary Endpoint
Enamel Lesions per BlueCheck
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts 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).

Arms & Interventions

Test Group

Experimental

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

Intervention: BlueCheck (Device)

Test Group

Experimental

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

Intervention: Prevident 5000ppm Booster Plus Toothpaste (Drug)

Outcomes

Primary Outcomes

Enamel Lesions per BlueCheck

Time Frame: Baseline, 4 weeks, and 12 weeks

Number of enamel lesions counted after using BlueCheck

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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