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Randomized, double-blind, placebo controlled, study

Ship JA et al., (2007) evaluated the safety and efficacy of a group of topical dry mouth products (toothpaste, mouth rinse, mouth spray and gel) containing olive oil, betaine and xylitol in a randomized, single-blinded, controlled, cross-over clinical study in 40 adults (aged 50-67 years) for one week. Subjects were randomly assigned at baseline to using the novel topical dry mouth products containing olive oil, betaine and xylitol (Xerostom®) daily for 1 week, or to maintain their normal dry mouth routine care. After 1 weeks, they were crossed over to the other dry mouth regimen. There were evaluated 8 aspects of xerostomia and found statistically significant differences between control and Xerostom (olive oil, betaine and xylitol) in overall mouth dryness (p= 0,038), overall tongue dryness (p= 0,002) and level of thirst (p= 0,001) favouring Xerostom® group.

The Visual Analogue Scale (VAS) showed statistically significant improvements in the dryness of the mouth and tongue and a decrease in thirst when using Xerostom® products as compared with their normal dry mouth routine.

The results demonstrated that the use of the novel topicaldry mouth products increased significantly unstimulated whole salivary flow rates, reduced complaints of xerostomia and improved xerostomia-associated quality of life. No clinically significant adverse events were observed.

Authors concluded that the daily use of topical dry mouth products containing olive oil, betaine and xylitol is safe and effective in relieving symptoms of dry mouth in a population with polypharmacy-induced xerostomia.

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