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NCT Number: NCT07819370

Enamel Lesion Detection With New DX 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.

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Key information

Conditions

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental Dreams, LLC

Lithonia, Georgia, 30038, United States

Location contact

Zerita Buchanan, DDS, MPH

CONTACT

[email protected]

404-289-7311

Zerita Buchanan, DDS, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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

Primary outcomes

  1. Enamel Lesions per BlueCheck

    Time frame: Baseline, 4 weeks, and 12 weeks

    Number of enamel lesions counted after using BlueCheck

Secondary outcomes

  1. Self-perceived reactions to BlueCheck application

    Time frame: Baseline, 4 weeks, and 12 weeks

    Questionnaire clinician and subject feedback on the BlueCheck application

  2. Enamel Lesions per Xray

    Time frame: Baseline, 4 weeks, and 12 weeks

    Number and location of visible enamel lesions on Xray

  3. Enamel lesions per intraoral camera

    Time frame: Baseline, 4 weeks, and 12 weeks

    Number and location of enamel lesions detected by an intraoral camera using a caries mode

  4. White spots

    Time frame: Baseline, 4 weeks, and 12 weeks

    Number and location of visible white spots per examiner's identification

Study contacts

Contact information is provided by the study sponsor or research team.

Zerita Buchanan, DDS, MPH

CONTACT

[email protected]

404-289-7311

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Collaborators

  • Dental Dreams, LLC

Registry information

Official study title

Early Enamel Lesion Detection and Management With a New Diagnostic Tool

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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