Objectives: The aim of this placebo-controlled, double-blinded, randomized clinical investigation was to evaluate the influence of 8% arginine-containing prophylaxis products on pain related parameters (Schiff and VAS scores) compared to a negative control in patients from a German dental clinic suffering from severe dentine hypersensitivity (DH) over 24 weeks.
Methods: After ethical approval by the Ethics Committee of the Martin Luther University Halle-Wittenberg (Germany), 101 informed patients having at least two teeth (no molars) with air blast DH scores 2, 3 (Schiff Cold Air Sensitivity Scale) were randomly assigned to either the control or test group. All were treated with a single application of the in-office paste followed by daily toothpaste use (control products without desensitizing ingredients and test products containing 8% arginine, both with the same level of fluoride).The Schiff and VAS scores were evaluated before and after application of the in-office paste and after 4, 8, and 24 weeks for both study teeth.
Results: A total of 98 patients completed the study. The distribution of subjects with DH Schiff scores 2 and 3 at screening was similar in both groups. There were no statistically significant differences in the Schiff and VAS scores at baseline between test and control subjects (p>0.05). The pooled data for tooth 1 and tooth 2 yielded significantly greater pain relief as assessed by the Schiff score in the test group than the control group at any appointment, both in the t-test and Wilcoxon signed rank test analyses (p<0.05). The VAS showed no significant differences between both groups.
Conclusions: Significant improvements (Schiff score, pain relief) in a German population were demonstrated after application of the in-office paste and over the 24- week period of brushing with the 8.0% arginine-containing toothpaste. This study was supported by Colgate-Palmolive Europe, Therwil, Switzerland. Support Funding Agency/Grant Number: Colgate-Palmolive Europe, Therwil, Switzerland. No. GASAS-1105X, PO No. 7501857177.