Methods: This study was a single-center, monadic design in healthy subjects segmented into three phases: Phase 1 recruited subjects from a location where this type of product could be purchased rather than via telephone. Phase 2 determined if the person was willing to use the experimental desensitizing gel after reading the product label. Phase 3 determined whether the subject used the experimental desensitizing gel correctly per label instruction and if the experimental desensitizing gel reduced sensitivity. Participating subjects self-applied the novel 12% w/w Strontium Acetate gel as required for 14 days, and were asked to complete a use and subjective efficacy questionnaire; product weight and change in sensitivity VAS from baseline to Day 3 and to Day 15 were also measured.
Results: Product use on the whole was found to be appropriate with only 12.8% of subjects not answering questions correctly. There was a statistically significant decrease (by about 25%) in the subjective VAS changes from baseline to Day 3, and a 54% reduction in sensitivity to Day 15 following use of the novel desensitizing gel. Regarding perceived efficacy, about 66% of users reported noticing relief from tooth sensitivity within the first three days with 71% of users rating the taste as pleasant. 56% of subjects reported relief from sensitivity within one day.
Conclusions: This (actual use) study was shown to demonstrate subject compliance to product labelling instructions. The novel Strontium containing topically applied desensitizing gel provided significant reductions in both subjective VAS assessments and subject perception of efficacy.