Efficacy of New Oral Rinse Containing Hyaluronic Acid in Xerostomia
Objectives: The aim of the present study was to evaluate the efficacy of a new oral rinse formulation containing hyaluronic acid and other functional ingredients in reducing the symptoms of xerostomia subjectively and objectively.
Methods: In this double-blind crossover study, subjects affected by xerostomia (unstimulated saliva flow rate (USFR) <0.2 mL/min) were assigned to GUM® HYDRAL® Oral Rinse (product A), the product A placebo rinse and Biotene® Oral Rinse (product B) for each study period. Subjects were instructed to use the assigned product four times a day. At baseline and end of each study period, the 10cm Visual Analog Scale (VAS) indicating the level of dry mouth and Xerostomia Questionnaire (XQ) were assessed as subjective measurements. USFR and Revised Oral Assessment Guide (ROAG) were also assessed as objective measurements. Wilcoxon signed-rank test was used for intragroup and intergroup comparisons.
Results: 37 patients (15 men/22 women, 58.2±12.9yr) completed all treatment modalities. All treatments decreased the VAS scale, and the total score of XQ were significantly decreased by product A or B. However, there was no statistically significant difference among treatment modalities. The use of product A or B showed an increase in USFR (A:0.16 to 0.24mL/min, p<0.0001; B:0.17 to 0.22mL/min, P<0.05). Product A or B improved the total score of ROAG, and the effectiveness of product A was significantly better than the placebo (p<0.0001) and product B (p<0.05). Product A showed a greater improvement than the placebo in two functional categories of ROAG: Tongue (p<0.001) and Saliva (p<0.01), and to product B in Tongue (p<0.05).
Conclusions: Efficacy with HYDRAL Oral Rinse in reducing the symptoms of xerostomia was demonstrated, and HYDRAL rinse was found to be more effective in some of objective measurements than the placebo or Biotene. HYDRAL and Biotene rinses increased USFR over 0.20mL/min as a normal threshold after two weeks of use.