Intraoralelectrostimulator for xerostomia relief : along-term, multicenter, open-label, uncontrolled, clinical trial

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Intraoralelectrostimulator for xerostomia relief : along-term, multicenter, open-label, uncontrolled, clinical trial

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Publication Article, peer reviewed scientific
Title Intraoralelectrostimulator for xerostomia relief : along-term, multicenter, open-label, uncontrolled, clinical trial
Author(s) Alajbeg, Ivan ; Falcão, Denise P ; Tran, Simon D ; Martín-Granizo, Rafael A ; Lafaurie, Gloria I ; Bautista Mendoza, Gloria R ; Pejda, Slavica ; Vuletić, Lea ; Mantilla, Rubén ; Leal, Soraya C ; Barreto Bezerra, Ana C ; Ménard, Henri A ; Kimoto, Suguru ; Pan, Shaoxia ; Maniegas Lozano, María L ; Krushinski, Cheryl A ; Melilli, Dario ; Campisi, Giuseppina ; Paderni, Carlo ; Matranga, Domenica ; Yepes, Juan F ; Lindh, Liselott ; Koray, Meltem ; Mumcu, Gonca ; Elad, Sharon ; Zeevi, Itai ; Aldape, Beatriz C ; López Sánchez, Rodrigo M ; Lassauzay, Clarie L ; Fromentin, Olivier ; Beiski, Ben Z ; Strietzel, Franz P ; Konttinen, Yrjö T ; Wolff, Andy ; Zunt, Susan L
Date 2012
English abstract
OBJECTIVE: A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period. STUDY DESIGN: The device was tested on a mixed sample of 94 patients with xerostomia in an open-label, uncontrolled, prospective multicenter trial. Statutory outcome assessments were done at 5th, 8th, and 11th months and analyzed by multiple comparisons. RESULTS: Improvements achieved at month 5 from baseline were sustained throughout the follow-up period for the primary outcome, xerostomia severity, and the secondary outcomes resting whole salivary flow rate, xerostomia frequency, oral discomfort, and difficulties in speech, swallowing, and sleeping. No significant side effects were detected. CONCLUSIONS: The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11-month period.
DOI http://dx.doi.org/10.1016/j.oooo.2012.01.012 (link to publisher's fulltext)
Publisher Elsevier
Host/Issue Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology;6
Volume 113
ISSN 2212-4403
Pages 773-781
Language eng (iso)
Subject(s) Medicine
Research Subject Categories::ODONTOLOGY
Handle http://hdl.handle.net/2043/14262 (link to this page)

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