Evaluation of the clinical efficacy of a betaine-containing mouthwash and an intraoral device for the treatment of dry mouth.

OBJECTIVE

An evaluation is made of the efficacy and safety of an intraoral device with a betaine (BET)-containing mouthwash in treating xerostomia.

METHODS

A total of 105 patients with dry mouth (xerostomia) were included in a randomized, non-blinded, parallel-group, controlled clinical trial. The patients were assigned to one of the three groups: A (night guard), B (mouthwash), or C (night guard and mouthwash). A xerostomia questionnaire was administered, and unstimulated salivary flow was measured. The Oral Health Impact Profile (OHIP) - 14 was assessed. All measurements were taken before and after treatment, which had a duration of 4 weeks. The patients in turn completed a treatment satisfaction questionnaire.

RESULTS

Ninety patients (eight men and 82 women) completed the study. All three treatments alleviated the symptoms of xerostomia, with improvement in the OHIP-14 scores and sialometry findings. There were no adverse effects. Patient satisfaction with the treatment received showed no statistically significant differences among the three groups; though, the patients in group A considered treatment to have been extremely beneficial in 10% of the cases, while 43% considered it to have been beneficial.

CONCLUSIONS

The daily use of a night guard and BET-containing mouthwash was seen to improve dry mouth during the 4-week duration of the study.