The clinical effect of a single direct topical application of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride on dentin hypersensitivity: the use of a cotton swab applicator versus the use of a fingertip.

OBJECTIVE: The primary objective of this examiner-blind, randomized clinical study was to compare the effect of a toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), in providing instant relief of dentin hypersensitivity when delivered as a single direct topical application using a cotton swab applicator versus using a fingertip. A secondary objective was to evaluate the effect on dentin hypersensitivity of the dentifrice after seven days of twice-daily at-home brushing, subsequent to the single direct topical application performed at the beginning of the study.
METHODS: Qualifying subjects possessed two baseline-designated hypersensitive teeth with a tactile hypersensitivity score of 10 to 50 grams of force (Yeaple Probe), and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). In the first phase of the study, subjects topically self-applied the test product using a fingertip, a previously validated method, for one of the hypersensitive teeth (fingertip test teeth), and a cotton swab applicator for the second hypersensitive tooth (swab test teeth). In the second phase of the study, subjects brushed with the test dentifrice twice daily for seven days. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted immediately after direct topical product application, and after the subsequent seven-day brushing period.
RESULTS: Eighty-four subjects complied with the study protocol and completed the study. Immediately after direct topical application, the fingertip test teeth and the swab test teeth exhibited statistically significant (p <0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 182.1%, respectively), and mean air blast hypersensitivity scores (58.1% and 56.3%, respectively). After the seven-day brushing period, the fingertip test teeth and the swab test teeth continued to exhibit statistically significant (p < 0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 190.5%, respectively) and mean air blast hypersensitivity scores (57.4% and 58.2%, respectively). No statistically significant (p > 0.05) differences were indicated between the fingertip test teeth and the swab test teeth with respect to mean tactile hypersensitivity scores or mean air blast hypersensitivity scores immediately after topical application (3.4% and 4.4%, respectively), or after seven days of twice-daily brushing with the product (0.41% and -1.90%, respectively).
CONCLUSION: The results of this examiner-blind clinical study support the conclusions that 1) both fingertip and cotton swab methods of application provide significant reductions in dentin hypersensitivity immediately after a single direct topical application of the 8.0% arginine-calcium carbonate dentifrice, 2) when topical application is followed by seven days of twice-daily brushing with the dentifrice, the sensitivity relief obtained instantly after topical application is maintained, and 3) after topical application and after seven days of brushing, neither method of topical application provided a level of control of dentin hypersensitivity that differed significantly from the other.

RCT Entities:   Population Interventions Outcomes