1. Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial
- Author
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Meltem Koray, Rafael Martín-Granizo, Domenica Matranga, Slavica Pejda, Claire Lassauzay, Ben Z. Beiski, Liselott Lindh, Ana Cristina Barreto Bezerra, L. Maniegas, Lea Vuletić, Rodrigo M. López Sánchez, Juan F. Yepes, Yrjö T. Konttinen, Suguru Kimoto, Soraya Coelho Leal, Sharon Elad, Beatriz Catalina Aldape Barrios, Giuseppina Campisi, Carlo Paderni, Iva Alajbeg, Denise Pinheiro Falcão, Itai Zeevi, Olivier Fromentin, Dario Melilli, Gonca Mumcu, Gloria Inés Lafaurie, Simon D. Tran, Shaoxia Pan, Cheryl A. Krushinski, Andy Wolff, Gloria Rocío Bautista Mendoza, Rubén D. Mantilla, Susan L. Zunt, Frank Peter Strietzel, Henri A Ménard, Lafaurie, Gloria Ines [0000-0003-3986-0625], Alajbeg, I, Falcão, DP, Tran, SD, Martín-Granizo, R, Lafaurie, GI, Matranga, D, Pejda, S, Vuletić, L, Mantilla, R, Leal, SC, Bezerra, AC, Ménard, HA, Kimoto, S, Pan, S, Maniegas, L, Krushinski, CA, Melilli, D, Campisi, G, Paderni, C, Mendoza, GR, Yepes, JF, Lindh, L, Koray, M, Mumcu, G, Elad, S, Zeevi, I, Barrios, BC, López Sánchez, RM, Lassauzay, C, Fromentin, O, Beiski, BZ, Strietzel, FP, Konttinen, YT, Wolff, A, and Zunt, SL
- Subjects
Male ,Time Factors ,Dentistry ,xerostomia ,intraoral saliva electrostimulator ,Primary outcome ,xerostomia, genNarino ,Medicine ,Prospective Studies ,Young adult ,Prospective cohort study ,Likelihood Functions ,Middle Aged ,Treatment Outcome ,Female ,Oral Surgery ,Open label ,Adult ,Sleep Wake Disorders ,Settore MED/50 - Scienze Tecniche Mediche Applicate ,Electric Stimulation Therapy ,Lingual Nerve ,Xerostomia ,Speech Disorders ,Xerostomía ,Nervio lingual ,Pathology and Forensic Medicine ,Settore MED/01 - Statistica Medica ,Young Adult ,Swallowing ,stomatognathic system ,Settore MED/28 - Malattie Odontostomatologiche ,Multicenter trial ,otorhinolaryngologic diseases ,Humans ,Radiology, Nuclear Medicine and imaging ,Dentistry (miscellaneous) ,Saliva ,Aged ,Chi-Square Distribution ,business.industry ,Clinical trial ,stomatognathic diseases ,Therapy, Computer-Assisted ,Surgery ,Estimulación eléctrica transcutánea del nervio ,business ,Deglutition Disorders ,Secretory Rate ,Chi-squared distribution ,Follow-Up Studies - 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.
- Published
- 2012