Dentinal hypersensitivity: a 12-week study of a novel dentifrice delivery system comparing different brushing times and assessing the efficacy for hard-to-reach molar teeth.
OBJECTIVE
This study was undertaken to confirm the efficacy of a novel 5% KNO3 gel-to-foam dentifrice, and to determine the effect of brushing duration on the relief offered from the novel dentifrice to subjects with sensitive molars.


METHODS
This was a randomized, examiner-blind, two-arm, parallel-group, 12-week, longitudinal study of 141 subjects, stratified into four groups based on the number of sensitive teeth (< 6 or > or = 6) and the presence or absence of sensitive molars. Subjects brushed with the test product twice daily for either 45 seconds or two minutes for eight weeks, and then continued for four weeks with their regular dentifrice. At baseline, four, eight, and 12 weeks, subjects provided subjective evaluations of their sensitivity, and their sensitive teeth were stimulated by air and Yeaple probe.


RESULTS
Both brushing groups and all four subgroups exhibited statistically significant reductions from baseline at each post-baseline visit in both their air and tactile sensitivity (p < 0.0001). Between-group comparisons revealed no statistically significant differences in air or tactile sensitivity among the groups. The two-minute group showed a small, but statistically significant increase in both air and tactile sensitivity four weeks after cessation of the test product (p < 0.04). At each post-baseline evaluation, statistically significant decreases from baseline were observed in both brushing groups for "maximum," "typical," and "minimum" subjective pain over the previous seven days (p < 0.001). There were no statistically significant differences between the brushing groups at any visit. For the subgroups with sensitive molars, there were significant decreases from baseline at each post-baseline visit, but no statistically significant differences between brushing groups. In the subgroups without sensitive molars, consistent reductions from baseline were only observed for "maximum" and "typical" pain levels, and at Week 4, the two-minute group had a statistically greater reduction in "minimum" pain level (p = 0.039). Both brushing groups and all four subgroups exhibited statistically significant reductions from baseline at each post-baseline visit in how much they were "bothered" by sensitivity in the previous week (p < 0.003). Between-group comparisons revealed no statistically significant differences.


CONCLUSIONS
A novel gel-to-foam dentifrice with 5% potassium nitrate can provide significant reductions in dentinal hypersensitivity, and this effect extends to hard-to-reach molar teeth. This study confirms that with this new dentifrice technology, the desensitizing efficacy from a 5% KNO3 dentifrice is independent of brushing duration.
Leight
R S
RS
Kirslan Consulting, Seminole, FL, USA.
Sufi
F
F
Gross
R
R
Mason
S C
SC
Barlow
A P
AP
D000293:Adolescent; D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D003802:Dentifrices / Q000008:administration & dosage* / Q000737:chemistry; D003807:Dentin Sensitivity / Q000473:pathology / Q000517:prevention & control*; D016503:Drug Delivery Systems; D005260:Female; D005782:Gels; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D008963:Molar / Q000473:pathology; D009566:Nitrates / Q000008:administration & dosage* / Q000737:chemistry; D017680:Potassium Compounds / Q000008:administration & dosage* / Q000737:chemistry; D016037:Single-Blind Method; D013997:Time Factors; D014099:Toothbrushing / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
D003802:Dentifrices; D005782:Gels; D009566:Nitrates; D017680:Potassium Compounds; C023844:potassium nitrate