Efficacy and Safety of an Intraoral Electrostimulation Device for Xerostomia Relief: A Multicenter, Randomized Trial

Dario Melilli, Carlo Paderni, Giuseppina Campisi, Soraya C. Leal, Ben Z. Beiski, Gloria I. Lafaurie, Beatriz C. Aldape Barrios, Shaoxia Pan, Itai Zeevi, Yrjö T. Konttinen, Denise P. Falcào, Cheryl A. Krushinski, Slavica Pejda, M. Lourdes Maniegas Lozano, Gloria R. Bautista Mendoza, Lea Vuletić, Ivan Alajbeg, Sharon Elad, Rodrigo M. Lõpez Sánchez, Meltem KorayRubén Mantilla, Frank P. Strietzel, Susan L. Zunt, Gonca Mumcu, Liselott Lindh, Rafael A. Martín-Granizo, Suguru Kimoto, Ana C. Barreto Bezerra, Simon D. Tran, Henri A. Ménard, Andy Wolff, Juan F. Yepes

Risultato della ricerca: Article

43 Citazioni (Scopus)

Abstract

Objective. To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. 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 Sjogren's syndrome and other sicca conditions in a 2-stage prospective, randomized, multicenter trial. Stage I was a double-blind, crossover stage designed to compare the effects of the electrically active device with the sham device, each used for 1 month, and stage II was a 3-month open-label stage designed to assess the long-term effects of the active device. Improvement in xerostomia severity from baseline was the primary outcome measure. Results. A total of 114 patients were randomized. In stage I, the active device performed better than the sham device 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), sleeping difficulty (P < 0.001), and resting salivary flow rate (P < 0.01). Conclusion. Our findings indicate that 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 end of the trial.
Lingua originaleEnglish
pagine (da-a)180-190
Numero di pagine11
RivistaArthritis and Rheumatism
Volume63
Stato di pubblicazionePublished - 2011

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Pharmacology (medical)

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    Melilli, D., Paderni, C., Campisi, G., Leal, S. C., Beiski, B. Z., Lafaurie, G. I., Barrios, B. C. A., Pan, S., Zeevi, I., Konttinen, Y. T., Falcào, D. P., Krushinski, C. A., Pejda, S., Lozano, M. L. M., Mendoza, G. R. B., Vuletić, L., Alajbeg, I., Elad, S., Lõpez Sánchez, R. M., ... Yepes, J. F. (2011). Efficacy and Safety of an Intraoral Electrostimulation Device for Xerostomia Relief: A Multicenter, Randomized Trial. Arthritis and Rheumatism, 63, 180-190.