An Exploratory Clinical Study to Monitor Clinical Efficacy of an Occluding Technology Dentifrice in Providing Short Term Relief from Dentinal Hypersensitivity.

OBJECTIVES

To examine dentin hypersensitivity (DH) at multiple time points over a 14-day period in participants who brushed twice daily with a 0.454% SnF2 dentifrice (Test) compared to a 0.76% sodium monofluorophosphate dentifrice with no known anti-sensitivity properties (Control).

METHODS

This was a two-week, single-center, randomized, controlled, examiner-blind, two-treatment, parallel-group study in healthy participants with DH. The sensitivity of two selected test teeth and of all sensitive teeth was assessed at baseline and after one, three, seven, 10, and 14 days' treatment in response to evaporative (air) Schiff sensitivity score and visual analogue scale [VAS]) and tactile (tactile threshold) stimuli. DH was also monitored using a shortened version of the Dentin Hypersensitivity Experience Questionnaire (DHEQ) and a single "Tooth Sensitivity Question" (TSQ).

RESULTS

Both groups had mean Schiff sensitivity scores that were statistically significantly improved from baseline on all days for the two test teeth and all qualifying teeth (p < 0.0001). There was a statistically significant difference between the dentifrices at Day 1 only, in favor of the Control dentifrice, for the two test teeth (0.28 [95% confidence intervals 0.03,0.53] p = 0.0282) or all qualifying teeth (0.17 [0.02,0.32] p = 0.0273). For tactile threshold, both dentifrices were statistically significantly improved from baseline from Day 3 onwards, with the Test dentifrice showing an improvement at Day 1 (p < 0.05). There were no significant statistical between-treatment differences at any time point. DHEQ questions revealed most participants experienced "sensitivity," "twinging," and "pain," with cold stimuli rated as the highest DH-eliciting. DHEQ Section 1 rating scores improved with the Test dentifrice, but not significantly statistically. DHEQ Section 2 scores statistically significantly improved with both dentifrices (p < 0.0002) with no differences between them. TSQ scores for both groups reduced over the time period. Both dentifrices were generally well-tolerated.

CONCLUSIONS

In this study, use of both the Test and Control dentifrices led to DH relief with few statistically significant differences between them. The DHEQ and TSQ showed a reduction of pain during the study period, but there was still a high level of discomfort. Further research on short term relief of DH is required.