Clinical Evaluation of a Mouthrinse for Xerostomia

Objectives: To evaluate the clinical efficacy of a new alcohol free fluoride mouthrinse (Act Total Care Dry Mouth) versus placebo for relief of xerostomia.

Methods: Twenty-one subjects with an unstimulated salivary flow rate <0.25ml/minute (xerostomia) were entered into a double masked two week crossover study. All subjects were randomly assigned to one of the two rinses to use for a period of one week followed by a “washout period” of one week. They were then assigned to use the alternate mouthrinse for one week. Subjects were evaluated on their subjective response to various attributes of the mouthrinse related to improvement of xerostomia symptoms. Evaluations were made both at home during product use as well as in the office as measured over a period of one hour.

Results: The results of the study showed that, using a VAS scale, 71% preferred it to other products they had tried previously compared to 35% in the placebo group.  Also, when subjects were asked about various attributes, the test product was significantly better than the placebo (p<0.05, McNemar Test) for the following: provides immediate relief, long-lasting relief, moisturizes and lubricates the mouth, has a good taste, and freshens breath. When subjects evaluated the product for moistness of oral tissues, they scored it up to 4 times the effect of the placebo rinse. Evaluation of the data also suggested a cumulative effect of the test product since scores of attributes were higher at 7 days than after initial usage.

Conclusions: This study supports the clinical efficacy of the test mouthrinse for relief of xerostomia symptoms.   Supported, in part, by a grant from Chattem, Inc – A Sanofi Company.