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

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

Research output: Contribution to journalArticle

41 Citations (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 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.

Original languageEnglish (US)
Pages (from-to)180-190
Number of pages11
JournalArthritis and Rheumatism
Volume63
Issue number1
DOIs
StatePublished - Jan 2011

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Xerostomia
Multicenter Studies
Safety
Equipment and Supplies
Lingual Nerve
Electric Power Supplies
Sjogren's Syndrome
Mouth Mucosa
Deglutition
Reflex
Electrodes
Quality of Life
Outcome Assessment (Health Care)

ASJC Scopus subject areas

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

Cite this

Strietzel, F. P., Lafaurie, G. I., Mendoza, G. R. B., Alajbeg, I., Pejda, S., Vuletić, L., ... Konttinen, Y. T. (2011). Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter, randomized trial. Arthritis and Rheumatism, 63(1), 180-190. https://doi.org/10.1002/art.27766

Efficacy and safety of an intraoral electrostimulation device for xerostomia relief : A multicenter, randomized trial. / Strietzel, Frank P.; Lafaurie, Gloria I.; Mendoza, Gloria R Bautista; Alajbeg, Ivan; Pejda, Slavica; Vuletić, Lea; Mantilla, Rubén; Falcào, Denise P.; Leal, Soraya C.; Bezerra, Ana C Barreto; Tran, Simon D.; Ménard, Henri A.; Kimoto, Suguru; Pan, Shaoxia; Martín-Granizo, Rafael A.; Lozano, M. Lourdes Maniegas; Zunt, Susan; Krushinski, Cheryl A.; Melilli, Dario; Campisi, Giuseppina; Paderni, Carlo; Dolce, Sonia; Yepes, Juan; Lindh, Liselott; Koray, Meltem; Mumcu, Gonca; Elad, Sharon; Zeevi, Itai; Barrios, Beatriz C Aldape; Lõpez Sánchez, Rodrigo M.; Beiski, Ben Z.; Wolff, Andy; Konttinen, Yrjö T.

In: Arthritis and Rheumatism, Vol. 63, No. 1, 01.2011, p. 180-190.

Research output: Contribution to journalArticle

Strietzel, FP, Lafaurie, GI, Mendoza, GRB, Alajbeg, I, Pejda, S, Vuletić, L, Mantilla, R, Falcào, DP, Leal, SC, Bezerra, ACB, Tran, SD, Ménard, HA, Kimoto, S, Pan, S, Martín-Granizo, RA, Lozano, MLM, Zunt, S, Krushinski, CA, Melilli, D, Campisi, G, Paderni, C, Dolce, S, Yepes, J, Lindh, L, Koray, M, Mumcu, G, Elad, S, Zeevi, I, Barrios, BCA, Lõpez Sánchez, RM, Beiski, BZ, Wolff, A & Konttinen, YT 2011, 'Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter, randomized trial', Arthritis and Rheumatism, vol. 63, no. 1, pp. 180-190. https://doi.org/10.1002/art.27766
Strietzel, Frank P. ; Lafaurie, Gloria I. ; Mendoza, Gloria R Bautista ; Alajbeg, Ivan ; Pejda, Slavica ; Vuletić, Lea ; Mantilla, Rubén ; Falcào, Denise P. ; Leal, Soraya C. ; Bezerra, Ana C Barreto ; Tran, Simon D. ; Ménard, Henri A. ; Kimoto, Suguru ; Pan, Shaoxia ; Martín-Granizo, Rafael A. ; Lozano, M. Lourdes Maniegas ; Zunt, Susan ; Krushinski, Cheryl A. ; Melilli, Dario ; Campisi, Giuseppina ; Paderni, Carlo ; Dolce, Sonia ; Yepes, Juan ; Lindh, Liselott ; Koray, Meltem ; Mumcu, Gonca ; Elad, Sharon ; Zeevi, Itai ; Barrios, Beatriz C Aldape ; Lõpez Sánchez, Rodrigo M. ; Beiski, Ben Z. ; Wolff, Andy ; Konttinen, Yrjö T. / Efficacy and safety of an intraoral electrostimulation device for xerostomia relief : A multicenter, randomized trial. In: Arthritis and Rheumatism. 2011 ; Vol. 63, No. 1. pp. 180-190.
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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 Sj{\"o}gren'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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T1 - Efficacy and safety of an intraoral electrostimulation device for xerostomia relief

T2 - A multicenter, randomized trial

AU - Strietzel, Frank P.

AU - Lafaurie, Gloria I.

AU - Mendoza, Gloria R Bautista

AU - Alajbeg, Ivan

AU - Pejda, Slavica

AU - Vuletić, Lea

AU - Mantilla, Rubén

AU - Falcào, Denise P.

AU - Leal, Soraya C.

AU - Bezerra, Ana C Barreto

AU - Tran, Simon D.

AU - Ménard, Henri A.

AU - Kimoto, Suguru

AU - Pan, Shaoxia

AU - Martín-Granizo, Rafael A.

AU - Lozano, M. Lourdes Maniegas

AU - Zunt, Susan

AU - Krushinski, Cheryl A.

AU - Melilli, Dario

AU - Campisi, Giuseppina

AU - Paderni, Carlo

AU - Dolce, Sonia

AU - Yepes, Juan

AU - Lindh, Liselott

AU - Koray, Meltem

AU - Mumcu, Gonca

AU - Elad, Sharon

AU - Zeevi, Itai

AU - Barrios, Beatriz C Aldape

AU - Lõpez Sánchez, Rodrigo M.

AU - Beiski, Ben Z.

AU - Wolff, Andy

AU - Konttinen, Yrjö T.

PY - 2011/1

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N2 - 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.

AB - 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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