Dentine hypersensitivity: a randomised, double-blind placebo-controlled study of the efficacy of a fluoride-sensitive teeth mouthrinse.
OBJECTIVE
Potassium and fluoride salts have been used in the treatment of dentine hypersensitivity (DH). The primary aim of this study was to compare a fluoride-containing mouthrinse product with a placebo rinse for the treatment of DH. A secondary aim was to compare effects on plaque index (PI) and gingivitis index (GI).


METHODS
The study was a double-blind, randomised, two-treatment parallel design involving 91 subjects with DH. At screening, an air evaporative stimulus (AES) was used for selection. Approximately 4 weeks later, at the baseline visit, DH was recorded, using a response-based visual analogue scale (VAS) from upper and lower incisors, canines, premolars and first molars in response to AES and from two to six teeth in response to a cold water stimulus (CWS). PI and GI were also recorded. Subjects were then allocated the test or placebo rinse. On days 28 and 56, VAS scores were again recorded for AES and CWS, with PI and GI recorded at day 56.


RESULTS
Both groups improved symptoms to day 28 and again to day 56. The majority of the data favoured the test rinse as more effective but there was no clear evidence for a statistically significant difference between test and placebo. PI at lingual sites approached significance for the test rinse.


CONCLUSIONS
The placebo response has again been shown to play a significant role in DH clinical trials and narrows the range over which to detect treatment differences. Study designs to minimise or prevent the placebo response in DH seem worthy of consideration.
Yates
R J
RJ
Division of Restorative Dentistry, Dental School, Bristol, UK.
Newcombe
R G
RG
Addy
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003774:Dental Plaque Index; D003807:Dentin Sensitivity / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D010512:Periodontal Index; D015990:Placebo Effect; D018709:Statistics, Nonparametric; D013997:Time Factors
D009067:Mouthwashes; D005459:Fluorides