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| Name | Class |
|---|---|
| Indiana University | OTHER |
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The goal of this clinical trial is to evaluate whether BlueCheck® can accurately detect and monitor early-stage dental caries (tooth decay) and their remineralization in adults. Participants will wear partial dentures with partially demineralized human enamel specimens. The main questions it aims to answer are:
BlueCheck® results will be compared against standard diagnostic methods (e.g., Nyvad criteria, Diagnodent readings, surface microhardness) to see if BlueCheck® provides an objective, accurate, and visual method of detecting and monitoring early-stage caries.
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BlueCheck | Device | Caries Detection and Monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of BlueCheck to detect early stage carious lesions | BlueCheck will be applied to the early stage enamel carious lesions and visually assessed whether they are highlighted blue | Day 0 |
| Specificity of BlueCheck to not visual highlight sound enamel | BlueCheck will be applied to sound enamel samples and visually assessed whether they are highlighted blue. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BlueCheck colouration of remineralised artificial carious lesions | Artificial carious lesions will be remineralised by application of fluoride containing toothpaste. Change in colouration of the lesions before and after remineralization in-situ will be compared to changes in surface microhardness over the same period. | Day 1, 7, 14, 21 and 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Lippert, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Research Institute | Indianapolis | Indiana | 46202-2876 | United States |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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