Caries, Enamel Lesions
Conditions
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.
Interventions
DEVICEBlueCheck
BlueCheck, a carious lesion detection formulated device, will be used to track enamel lesions for patients who are newly receiving a high fluoride toothpaste.
DRUGPrevident 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
Sponsors
Colgate Palmolive
Dental Dreams, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enamel Lesions per BlueCheck | Baseline, 4 weeks, and 12 weeks | Number of enamel lesions counted after using BlueCheck |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-perceived reactions to BlueCheck application | Baseline, 4 weeks, and 12 weeks | Questionnaire clinician and subject feedback on the BlueCheck application |
| Enamel Lesions per Xray | Baseline, 4 weeks, and 12 weeks | Number and location of visible enamel lesions on Xray |
| Enamel lesions per intraoral camera | Baseline, 4 weeks, and 12 weeks | Number and location of enamel lesions detected by an intraoral camera using a caries mode |
| White spots | Baseline, 4 weeks, and 12 weeks | Number and location of visible white spots per examiner's identification |
Countries
United States
Contacts
CONTACTZerita Buchanan, DDS, MPH
Outcome results
None listed