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

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

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Publication Article, peer reviewed scientific
Title Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter randomized trial
Author(s) Strietzel, Frank P ; Lafaurie, Gloria I ; Bautista Mendoza, Gloria R ; Alajbeg, Ivan ; Pejda, Slavica ; Vuletić, Lea ; Mantilla, Rubén ; Falcão, Denise P ; Leal, Soraya C ; Barreto Bezerra, Ana C ; Tran, Simon D ; Ménard, Henri A ; Kimoto, Suguru ; Pan, Shaoxia ; Martín-Granizo, Rafael A ; Maniegas Lozano, M Lourdes ; Zunt, Susan L ; Krushinski, Cheryl A ; Melilli, Dario ; Campisi, Giuseppina ; Paderni, Carlo ; Dolce, Sonia ; Yepes, Juan F ; Lindh, Liselott ; Koray, Meltem ; Mumcu, Gonca ; Elad, Sharon ; Zeevi, Itai ; Aldape Barrios, Beatriz C ; López Sánchez, Rodrigo M ; Beiski, Ben Z ; Wolff, Andy ; Konttinen, Yrjö T
Date 2011
English 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.
DOI http://dx.doi.org/10.1002/art.27766 (link to publisher's fulltext)
Host/Issue Arthritis and rheumatism;1
Volume 63
ISSN 0004-3591
Pages 180-90
Language eng (iso)
Subject(s) xerostomia
dry mouth
salivary gland hypofunction
saliva
electrical stimulation
electrostimulation
Sjögren’s syndrome
Medicine
Research Subject Categories::ODONTOLOGY
Handle http://hdl.handle.net/2043/10735 (link to this page)

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