METHODS: This was a single-center, parallel group, double-blind, stratified clinical study conducted in San Francisco, California, USA. Qualifying adult male and female subjects who presented two hypersensitive teeth with a tactile
hypersensitivity score (Yeaple Probe) between 10-50 grams of force and an air blast
hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline
hypersensitivity scores and randomly assigned within strata to one of two treatment groups: (1) A Test
Paste, a desensitizing
paste containing 8%
arginine and
calcium carbonate (Colgate-Palmolive Co); and (2) A Control
Paste,
Nupro pumice prophylaxis
paste (
Dentsply Professional). Subjects received a professionally-administered scaling procedure, after which they were re-examined for tactile and air blast
dentin hypersensitivity (Post-Scaling Examinations). The assigned
pastes were then applied as the final step to the professional dental cleaning procedure. Tactile and air blast
dentin hypersensitivity examinations were again performed immediately after
paste application. Subjects were provided with a commercially-available non-desensitizing
dentifrice containing 0.243%
sodium fluoride (Crest Cavity Protection, Procter & Gamble Co.) and an adult soft-bristled toothbrush and were instructed to brush their teeth for 1 minute, twice daily at home using only the toothbrush and
dentifrice provided, for the next 12 weeks. Subjects returned to the testing facility 4 and 12 weeks after the single application of Test or Control
paste, having refrained from all
oral hygiene procedures and
chewing gum for 8 hours and from eating and drinking for 4 hours, prior to each follow-up visit. Assessments of tactile and air blast
hypersensitivity, and examinations of oral soft and hard tissue were repeated at these 4- and 12-week examinations.
RESULTS: 68 subjects completed the 12-week study. No statistically significant differences from baseline scores were indicated at the Post-Scaling Examinations for either the Test
Paste or Control
Paste groups. Immediately following product application and 4 weeks after product application, subjects assigned to the Test
Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (44.1% and 45.9% respectively) and mean tactile
hypersensitivity scores (156.2% and 170.3% respectively). At the same time points, subjects assigned to the Control
Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (15.1% and 8.9% respectively) and mean tactile
hypersensitivity scores (43.1% and 8.3% respectively). Immediately following application of the assigned
paste and 4 weeks later, the Test
Paste group demonstrated statistically significant reductions in
dentin hypersensitivity with respect to baseline-adjusted mean air blast (34.1% and 40.6% respectively) and mean tactile
hypersensitivity scores (79.0% and 149.6% respectively), compared to the Control
Paste group. No statistically significant differences were exhibited between
paste groups at the Post-Scaling and 12-week examinations with respect to mean tactile and baseline-adjusted mean air blast
hypersensitivity scores.