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

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 th...

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Published in:	Arthritis & rheumatology (Hoboken, N.J.) Vol. 63; no. 1; pp. 180 - 190
Main Authors:	Strietzel, Frank P., Lafaurie, Gloria I., Mendoza, Gloria R. Bautista, Alajbeg, Ivan, Pejda, Slavica, Vuletić, Lea, Mantilla, Rubén, Falcão, 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 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, Barrios, Beatriz C. Aldape, López Sánchez, Rodrigo M., Beiski, Ben Z., Wolff, Andy, Konttinen, Yrjö T.
Format:	Journal Article
Language:	English
Published:	Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-01-2011 Wiley Wiley Subscription Services, Inc
Subjects:	Adult Aged Biological and medical sciences Diseases of the osteoarticular system Double-Blind Method dry mouth Electric Stimulation Therapy - adverse effects Electric Stimulation Therapy - instrumentation Electric Stimulation Therapy - methods electrical stimulation electrostimulation Female Humans Intention to Treat Analysis Male Medical sciences Middle Aged Mouth Mucosa Prospective Studies saliva salivary gland hypofunction Severity of Illness Index Sjogren's Syndrome - complications Sjogren's Syndrome - therapy Sjögren’s syndrome Treatment Outcome xerostomia Xerostomia - etiology Xerostomia - therapy Oral cavity Salivary gland disease Toxicity Device Rheumatology ENT disease Xerostomia Aptyalism
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Summary:	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.
Bibliography:	ClinicalTrials.gov identifier: NCT00509808. Dr. Zunt served as principal investigator in a study funded by Parion Sciences. Mr. Beiski and Dr. Wolff own stock in Saliwell Ltd. and hold patents as coinventors of intraoral electronic medical devices. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23
ISSN:	0004-3591 2326-5191 1529-0131 1529-0131 2326-5205
DOI:	10.1002/art.27766