Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter randomized trial.

Arthritis Rheum. 2010 Sep 29. [Epub ahead of print]
CharitéCentre 3 for Dental, Oral and Maxillary Medicine, Department of Oral Medicine, Dental Radiology and Oral Surgery, Charité Universitätsmedizin Berlin (Berlin, Germany).


OBJECTIVE: The objective of the study was to evaluate the efficacy in treating xerostomia and the safety of an intraoral electrostimulation device, containing stimulating electrodes, an electronic circuit and a power source. The device delivers electrostimulation through the oral mucosa to the lingual nerve, in order to enhance the salivary reflex.
METHODS: The device was tested on a sample of patients with xerostomia due to Sjögren's syndrome and other sicca conditions in a prospective randomized multi-center trial consisting of two stages: (I) a double blind, cross-over designed stage to compare the effects of the electrically "active" device with the "sham" device, both used for one month, and (II) a 3-month open label stage to assess the long-term influence of the "active" device. Improvement of xerostomia severity from baseline was the primary outcome.
RESULTS: A total of 114 subjects were randomized. In Stage I, "active" device performed better than "sham" for patient-reported xerostomia severity (p<0.002), xerostomia frequency (p<0.05), quality of life impairment (p<0.01) and swallowing difficulty (p<0.02). At the end of Stage II, statistically significant improvements were verified for patient-reported xerostomia severity (p<0.0001), xerostomia frequency (p<0.0001), oral discomfort (p<0.001), speech difficulty (p<0.02) and sleeping difficulty (p<0.001), and for resting salivary flow-rate (p<0.01).
CONCLUSION: Daily use of the device alleviated oral dryness, discomfort and some complications of xerostomia, such as speech and sleeping difficulties, and increased salivary output. The results show a cumulative positive effect of the device over the period of the study, from baseline to the trial's end.


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