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

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dc.contributor.authorStrietzel, Frank P
dc.contributor.authorLafaurie, Gloria Ines
dc.contributor.authorBautista Mendoza, Gloria R.
dc.contributor.authorAlajbeg, Ivan
dc.contributor.authorPejda, Slavica
dc.contributor.authorVuletić, Lea
dc.contributor.authorMantilla, Rubén
dc.contributor.authorFalcão, Denise P.
dc.contributor.authorLeal, Soraya C.
dc.contributor.authorBarreto Bezerra, Ana C.
dc.contributor.authorTran, Simon D.
dc.contributor.authorMénard, Henri A.
dc.contributor.authorKimoto, Suguru
dc.contributor.authorPan, Shaoxia
dc.contributor.authorMartín-Granizo, Rafael A.
dc.contributor.authorManiegas Lozano, M. Lourdes
dc.contributor.authorZunt, Susan L.
dc.contributor.authorKrushinski, Cheryl A.
dc.contributor.authorMelilli, Dario
dc.contributor.authorCampisi, Giuseppina
dc.contributor.authorPaderni, Carlo
dc.contributor.authorDolce, Sonia
dc.contributor.authorYepes, Juan F.
dc.contributor.authorLindh, Liselott
dc.contributor.authorKoray, Meltem
dc.contributor.authorMumcu, Gonca
dc.contributor.authorElad, Sharon
dc.contributor.authorZeevi, Itai
dc.contributor.authorAldape Barrios, Beatriz C.
dc.contributor.authorLópez Sánchez, Rodrigo M.
dc.contributor.authorBeiski, Ben Z.
dc.contributor.authorWolff, Andy
dc.contributor.authorKonttinen, Yrjö T.
dc.contributor.orcidLafaurie, Gloria Ines [0000-0003-3986-0625]
dc.date.accessioned2021-02-02T13:28:04Z
dc.date.available2021-02-02T13:28:04Z
dc.date.issued2011
dc.description.abstractenglishTo 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. 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. 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). 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.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1002/art.27766
dc.identifier.instnameinstname:Universidad El Bosquespa
dc.identifier.issn1529-0131
dc.identifier.reponamereponame:Repositorio Institucional Universidad El Bosquespa
dc.identifier.repourlhttps://repositorio.unbosque.edu.co
dc.identifier.urihttps://hdl.handle.net/20.500.12495/5230
dc.language.isoeng
dc.publisherWileyspa
dc.publisher.journalArthritis & Rheumatismspa
dc.relation.ispartofseriesArthritis & Rheumatism, 1529-0131, Vol. 63, No. 1, 2011 p. 180-190spa
dc.relation.urihttps://onlinelibrary.wiley.com/doi/full/10.1002/art.27766
dc.rights.accessrightshttps://purl.org/coar/access_right/c_abf2
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess
dc.rights.accessrightsAcceso abierto
dc.rights.creativecommons2011-01
dc.rights.localAcceso abiertospa
dc.subject.keywordsOral cavityspa
dc.subject.keywordsToxicityspa
dc.subject.keywordsRheumatologyspa
dc.titleEfficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trialspa
dc.title.translatedEfficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trialspa
dc.type.coarhttps://purl.org/coar/resource_type/c_6501
dc.type.driverinfo:eu-repo/semantics/article
dc.type.hasversioninfo:eu-repo/semantics/publishedVersion
dc.type.localArtículo de revista

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