This will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral water) over a ten day period.
This modified in situ model study will evaluate the mode-of-action of an experimental dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride dentifrice and a negative control (mineral water). The study treatments will be administered for a total of 10 days, with participants wearing two appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of occlusion. In addition, the robustness of any occlusion generated by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
26
Dentifrice containing 0.454% stannous fluoride
Dentifrice containing 0.76% sodium monofluorophosphate
Commercially available mineral water
GSK Investigational Site
Bristol, United Kingdom
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Time frame: Baseline and Day 8
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Time frame: Baseline, Day 1, 4, and 10
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