Fischman SL et al (2004)

USE OF ESSENTIAL OIL-CONTAINING MOUTHRINSES BY XEROSTOMIC INDIVIDUALS: DETERMINATION OF POTENTIAL FOR ORAL MUCOSAL IRRITATION¹

Objective
To assess the irritation and drying potential of LISTERINE^® Antiseptic in patients with documented xerostomia. This study followed an "exaggerated&endash;use" clinical model, meaning that exposures to the mouthrinse exceeded those recommended in label directions.

Methods
After receiving a baseline oral soft-tissue examination, 19 qualifying female subjects with xerostomia secondary to Sjogren’s syndrome, mean age 61 years, were randomly assigned to either LISTERINE^® Antiseptic or a 5% hydroalcohol (negative control) rinse. Subjects rinsed unsupervised with 20 mL for 30 seconds three times daily (150% of the recommended daily dose) for the next 14 days and received soft-tissue examinations on days 7 and 14. After a 1-week washout period, subjects switched to the alternate rinse, and the examination and rinsing regimens were repeated for 2 weeks.

Results
LISTERINE^® Antiseptic had a low potential for irritation. At the 7&endash;day examination, only 2 subjects had minor oral mucosal abnormalities attributable to the test rinses. Both subjects were using LISTERINE^® Antiseptic. At the 14&endash;day exam, both subjects had normalized. Assessment of salivary flow rates indicated no statistically significant differences in salivary flow between periods (prerinse/postrinse) or treatment groups.

Key Quotes
"...the exaggerated use of the essential oil mouthrinse did not result in any observed oral dryness compared to the control rinse containing a considerably lower alcohol level, or in a clinically significant difference in oral irritation, even in this xerostomic population which would be the most vulnerable to 'drying'."

"This study in extremely xerostomic patients indicates that the essential oil mouthrinse can be safely recommended to such individuals in view of its minimal potential for oral mucosal irritation."

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REFERENCES

1. Fischman SL, Aguirre A, Charles CH. Use of essential oil-containing mouthrinses by xerostomic individuals: determination of potential for oral mucosal irritation. Am J Dent. 2004;17:23-26.