An interventional study of Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice and Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice in Caries, sponsored by Procter and Gamble. Completed at 1 site in Australia. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Procter and Gamble · Not applicable, Interventional, and Treatment
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.
Procter and Gamble is the lead sponsor of 80 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
Drug: Toms of Maine 0 ppm Fluoride Dentifrice
Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
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.
Time frame: 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.
Time frame: 14 days
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Procter and Gamble