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Withdrawn due to business reasons
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This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride Free toothpaste | Placebo Comparator | Fluoride free (0%), silica based toothpaste |
|
| 1.1% Fluoride toothpaste | Experimental | Prevident 5000 Plus, silica based toothpaste |
|
| 0.243% Fluoride Toothpaste | Active Comparator | silica based fluoride toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Free toothpaste | Drug | Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water. |
| Measure | Description | Time Frame |
|---|---|---|
| Mineral Change (delta Z) | Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions, vol % µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change ( ΔZ). | Baseline |
| Mineral Change (delta Z) | Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of brushing while wearing the study oral retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions, vol % µm). These post use values will be compared to the baseline values to give a delta mineral change ( ΔZ). | 2 weeks (from Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bennet Amaechi, PhD, DDS | University of Texas | Principal Investigator |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014002 | Tin Fluorides |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| 1.1% Fluoride toothpaste | Drug | Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water. |
|
|
| 0.243% Fluoride toothpaste | Drug | Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water. |
|
|
| D017971 |
| Tin Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |