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

Arthritis Rheum. 2010 Sep 29. [Epub ahead of print]

Strietzel FP, Lafaurie GI, Bautista Mendoza GR, Alajbeg I, Pejda S, Vuletić L, Mantilla R, Falcão DP, Leal SC, Barreto Bezerra AC, Tran SD, Ménard HA, Kimoto S, Pan S, Martín-Granizo RA, Maniegas Lozano ML, Zunt SL, Krushinski CA, Melilli D, Campisi G, Paderni C, Dolce S, Yepes JF, Lindh L, Koray M, Mumcu G, Elad S, Zeevi I, Aldape Barrios BC, López Sánchez RM, Beiski BZ, Wolff A, Konttinen YT.

CharitéCentre 3 for Dental, Oral and Maxillary Medicine, Department of Oral Medicine, Dental Radiology and Oral Surgery, Charité Universitätsmedizin Berlin (Berlin, Germany).

Abstract

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.