The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
US marketed toothpaste containing 1150ppm of F
Experimental toothpaste containing 0ppm F
Experimental toothpaste containing 250ppm F
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Time frame: 4 weeks
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Time frame: 4 weeks
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth)
Time frame: 4 weeks
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax)
Time frame: 4 weeks
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Experimental toothpaste containing 1150ppm F