Sjögren's Syndrome

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

  1. Frank P. Strietzel1,
  2. Gloria I. Lafaurie2,
  3. Gloria R. Bautista Mendoza2,
  4. Ivan Alajbeg3,
  5. Slavica Pejda3,
  6. Lea Vuletić3,
  7. Rubén Mantilla4,
  8. Denise P. Falcão5,
  9. Soraya C. Leal5,
  10. Ana C. Barreto Bezerra5,
  11. Simon D. Tran6,
  12. Henri A. Ménard7,
  13. Suguru Kimoto8,
  14. Shaoxia Pan9,
  15. Rafael A. Martín-Granizo10,
  16. M. Lourdes Maniegas Lozano10,
  17. Susan L. Zunt11,‡,
  18. Cheryl A. Krushinski11,
  19. Dario Melilli12,
  20. Giuseppina Campisi12,
  21. Carlo Paderni12,
  22. Sonia Dolce12,
  23. Juan F. Yepes13,
  24. Liselott Lindh14,
  25. Meltem Koray15,
  26. Gonca Mumcu16,
  27. Sharon Elad17,
  28. Itai Zeevi17,
  29. Beatriz C. Aldape Barrios18,
  30. Rodrigo M. López Sánchez18,
  31. Ben Z. Beiski19,§,
  32. Andy Wolff19,§,*,
  33. Yrjö T. Konttinen20

Article first published online: 28 DEC 2010

DOI: 10.1002/art.27766

Issue

Arthritis & Rheumatism

Arthritis & Rheumatism

Volume 63, Issue 1, pages 180–190, January 2011

Additional Information

How to Cite

Strietzel, F. P., Lafaurie, G. I., Mendoza, G. R. B., Alajbeg, I., Pejda, S., Vuletić, L., Mantilla, R., Falcão, D. P., Leal, S. C., Bezerra, A. C. B., Tran, S. D., Ménard, H. A., Kimoto, S., Pan, S., Martín-Granizo, R. A., Lozano, M. L. M., Zunt, S. L., Krushinski, C. A., Melilli, D., Campisi, G., Paderni, C., Dolce, S., Yepes, J. F., Lindh, L., Koray, M., Mumcu, G., Elad, S., Zeevi, I., Barrios, B. C. A., López Sánchez, R. M., Beiski, B. Z., Wolff, A. and Konttinen, Y. T. (2011), Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter, randomized trial. Arthritis & Rheumatism, 63: 180–190. doi: 10.1002/art.27766

Author Information

  1. 1

    Charité Universitätsmedizin Berlin, Berlin, Germany

  2. 2

    Universidad El Bosque, Bogotá, Colombia

  3. 3

    University of Zagreb, Zagreb, Croatia

  4. 4

    Clínica de Artritis y Rehabilitación, Bogotá, Colombia

  5. 5

    Universidade de Brasilia, Brasilia, Brazil

  6. 6

    McGill University, Montreal, Quebec, Canada

  7. 7

    McGill University and McGill University Health Center, Montreal, Quebec, Canada

  8. 8

    Nihon University School of Dentistry at Mastudo, Mastudo, Japan

  9. 9

    Hospital of Stomatology and Peking University, Beijing, China

  10. 10

    Hospital Clínico San Carlos, Madrid, Spain

  11. 11

    Indiana University, Indianapolis

  12. 12

    Università di Palermo, Palermo, Italy

  13. 13

    University of Kentucky, Lexington

  14. 14

    Malmö University, Malmö, Sweden

  15. 15

    Istanbul University, Istanbul, Turkey

  16. 16

    University of Marmara, Istanbul, Turkey

  17. 17

    Hebrew University Hadassah School of Dental Medicine, Jerusalem, Israel

  18. 18

    Universidad Nacional Autónoma de Mexico, Mexico City, Mexico

  19. 19

    Saliwell Ltd., Harutzim, Israel

  20. 20

    Helsinki University Central Hospital, University of Helsinki, and ORTON Orthopaedic Hospital, Helsinki, and COXA Hospital for Joint Replacement, Tampere, Finland

  1. ‡

    Dr. Zunt served as principal investigator in a study funded by Parion Sciences.

  2. §

    Mr. Beiski and Dr. Wolff own stock in Saliwell Ltd. and hold patents as coinventors of intraoral electronic medical devices.

*Saliwell Ltd., 65 Hatamar Street, Harutzim 60917, Israel

  1. †

    ClinicalTrials.gov identifier: NCT00509808.

Publication History

  1. Issue published online: 28 DEC 2010
  2. Article first published online: 28 DEC 2010
  3. Accepted manuscript online: 29 SEP 2010 01:52PM EST
  4. Manuscript Accepted: 21 SEP 2010
  5. Manuscript Received: 14 APR 2010

Funded by

  • Canadian Institutes of Health Research to McGill University (CIHR Program to Stimulate International Research Initiatives)
  • Swedish Laryng Foundation to Malmö University
  • Academy of Finland
  • Finska Läkaresällskapet
  • Helsinki University Central Hospital
  • ORTON Foundation to the University of Helsinki. Saliwell Ltd. (Harutzim, Israel)

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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 Sjögren'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.

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