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The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice | Active Comparator |
| |
| Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice | Active Comparator |
| |
| Toms of Maine 0 ppm Fluoride Dentifrice | Sham Comparator |
| |
| Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice | Active Comparator |
| |
| 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice | Active Comparator |
| |
| 1100 ppm (0.454% Stannous fluoride) Dentifrice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice | Drug | Each subject will use this product during one of the six treatment periods in the crossover study design. |
| Measure | Description | Time Frame |
|---|---|---|
| Mineral Density | The percent mineral profile of each enamel/dentinel slab's demineralized control and remineralized/treated lesion, obtained from the microdensitometry analysis, will be compared with the median sound enamel percent mineral profile of the same section. A negative value indicates mineral has been lost and, therefore, the lesion has progressed, whereas a positive value indicates mineral has been gained and, therefore, the lesion has regressed. | 14 days |
| Scanning Electron Microscopy (SEM) | SEM imaging and SEM-EDS analysis will be conducted on TMR sections and whole sections of dentine lesions treated in situ to assess the occlusion of dentine tubules and distribution of elements within the lesions following the experiment. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Melbourne | Melbourne | Australia |
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| Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice | Drug | Each subject will use this product during one of the six treatment periods in the crossover study design. |
|
| Toms of Maine 0 ppm Fluoride Dentifrice | Drug | Each subject will use this product during one of the six treatment periods in the crossover study design. |
|
| Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice | Drug | Each subject will use this product during one of the six treatment periods in the crossover study design. |
|
| 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice | Drug | Each subject will use this product during one of the six treatment periods in the crossover study design. |
|
| 1100 ppm (0.454% Stannous fluoride) Dentifrice | Drug | Each subject will use this product during one of the six treatment periods in the crossover study design. |
|
| ID | Term |
|---|---|
| C012980 | fluorophosphate |
| D003802 | Dentifrices |
| D014002 | Tin Fluorides |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017971 | Tin Compounds |
| D002327 | Cariostatic Agents |
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