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An Exploratory Randomised Study to Evaluate the Efficacy of an Experimental Occlusion-based Dentifrice in the Relief
Purpose:
To compare the efficacy of a 2.5% w/w smaller particle-size (ca 4 µm) calcium sodium phosphosilicate (CSPS) dentifrice (test) to an occluding dentifrice (8% w/w arginine) (comparator) and a negative control dentifrice in an 8-week, randomised, controlled, parallel-group, stratified (maximum baseline Schiff sensitivity score) study in adults with dentin hypersensitivity.
Materials And Methods:
The sensitivity of two selected teeth was assessed at baseline and after 1, 2, 4 and 8 weeks in response to evaporative (air) (Schiff sensitivity score and visual analogue scale [VAS]) and tactile (tactile threshold) stimuli.
Results:
Of 151 randomised subjects, 147 completed the study. Statistically significant changes from baseline were reported for test and comparator dentifrices at all weeks on all measures (p < 0.05) with no statistically significant differences between them. The negative control dentifrice group was statistically significantly different from baseline in all measures by week 8 (p < 0.05). Test and comparator dentifrices demonstrated statistically significantly greater improvements in Schiff sensitivity from week 2 compared to the negative control (p < 0.05). There was a statistically significant difference in favour only of the comparator dentifrice over the negative control at week 8 when examining tactile threshold (p = 0.0435) and at week 4 with VAS (p = 0.0425), with no other between-group differences. The dentifrices were generally well tolerated.
Conclusion:
No statistically significant differences were found between a small particle size 2.5% w/w CSPS dentifrice and an 8% w/w arginine dentifrice in terms of a dentine hypersensitivity decrease.
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