Enamel Caries Clinical Trial
Official title:
An in Situ Clinical Trial to Evaluate the Efficacy of a Calcium and Phosphate Enriched Sodium Monofluorophosphate Toothpaste on Enamel Lesion Remineralisation
Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative control toothpaste with no fluoride.
Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will
accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that
at least 50 subjects will complete the study. All 60 subjects will have two human enamel
specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial
denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a
subset will have an additional two enamel specimens (type N) placed in their partial denture
for TMR measurement. All enamel specimens will have been partially demineralized using lactic
acid in the laboratory prior to placement in subjects' dentures.
Subjects will receive a dental prophylaxis at the start of the trial and then brush their
teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase
between each crossover period, subjects will return to brushing with their regular toothpaste
for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a
fluoride-free toothpaste for the 2 to 3 days before the next test period.
During each test period, subjects will be asked to brush with their allocated toothpaste at
home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing
procedure will be performed at home each morning following breakfast and right before going
to bed on each evening. Subjects must wear their partial denture for 24 hours a day during
the test phase.
At final visit of each test period, subjects will be instructed to brush their teeth with the
randomly assigned trial toothpaste. Enamel specimens will be removed from denture and
transferred to analyst for laboratory analyses.
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