Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study

Abstract

To assess the efficacy of Pro-Argin with respect to the oral health-related quality of life (OHRQoL) and cervical dentine hypersensitivity (CDH) in subjects with CDH for 24 weeks compared to a control group. Three study centers (one each in France, Germany, and Switzerland) included 273 subjects for 24 weeks. Patients with CDH involving at least two non-molar teeth and those with Schiff scores (cold air sensitivity scale) of 2 or 3 were included. The primary study parameter was a change in the OHRQoL from baseline to 24 weeks, as assessed by the Oral Health Impact Profile (OHIP)-49 questionnaire within and between the randomized groups. Patients were randomly assigned to the test group (TG) or the control group (CG). Prophylaxis paste and toothpaste in the TG contained 8% arginine and calcium carbonate. The toothpaste in the CG contained sodium monofluorophosphate. The level of significance was set at 5% (p = 0.05). The OHIP-49 at 24 weeks was analyzed using the analysis of covariance (ANCOVA). The mean OHIP-49 score after 24 weeks (adjusted for baseline) was significantly lower in the TG than in the CG (p = 0.005, ANCOVA). The OHIP-49 pain-related items adjusted for the baseline values also showed significant differences between the groups (p = 0.025, ANCOVA). The treatment over a period of 24 weeks using products based on the Pro-Argin technology showed a significant improvement in the OHRQoL compared to the placebo application.