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

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Fältnamn	Indikatorer	Metadata
000		04480naa a2200757 4500
001		oai:DiVA.org:mau-6496
003		SwePub
008		200228s2011 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:mau:diva-64962 URI
024	7	a https://doi.org/10.1002/art.277662 DOI
040		a (SwePub)mau
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Strietzel, Frank P4 aut
245	1 0	a Efficacy and safety of an intraoral electrostimulation device for xerostomia relief :b A multicenter randomized trial
264		c 2010-12-28
264	1	b Wiley,c 2011
338		a print2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Odontologi0 (SwePub)302162 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Dentistry0 (SwePub)302162 hsv//eng
653		a xerostomia
653		a dry mouth
653		a salivary gland hypofunction
653		a saliva
653		a electrical stimulation
653		a electrostimulation
653		a Sjögren’s syndrome
700	1	a Lafaurie, Gloria I4 aut
700	1	a Bautista Mendoza, Gloria R4 aut
700	1	a Alajbeg, Ivan4 aut
700	1	a Pejda, Slavica4 aut
700	1	a Vuleti?, Lea4 aut
700	1	a Mantilla, Rubén4 aut
700	1	a Falcão, Denise P4 aut
700	1	a Leal, Soraya C4 aut
700	1	a Barreto Bezerra, Ana C4 aut
700	1	a Tran, Simon D4 aut
700	1	a Ménard, Henri A4 aut
700	1	a Kimoto, Suguru4 aut
700	1	a Pan, Shaoxia4 aut
700	1	a Martín-Granizo, Rafael A4 aut
700	1	a Maniegas Lozano, M Lourdes4 aut
700	1	a Zunt, Susan L4 aut
700	1	a Krushinski, Cheryl A4 aut
700	1	a Melilli, Dario4 aut
700	1	a Campisi, Giuseppina4 aut
700	1	a Paderni, Carlo4 aut
700	1	a Dolce, Sonia4 aut
700	1	a Yepes, Juan F4 aut
700	1	a Lindh, Liselottu Malmö högskola,Odontologiska fakulteten (OD)4 aut0 (Swepub:mau)odlili
700	1	a Koray, Meltem4 aut
700	1	a Mumcu, Gonca4 aut
700	1	a Elad, Sharon4 aut
700	1	a Zeevi, Itai4 aut
700	1	a Aldape Barrios, Beatriz C4 aut
700	1	a López Sánchez, Rodrigo M4 aut
700	1	a Beiski, Ben Z4 aut
700	1	a Wolff, Andy4 aut
700	1	a Konttinen, Yrjö T4 aut
710	2	a Malmö högskolab Odontologiska fakulteten (OD)4 org
773	0	t Arthritis and Rheumatismd : Wileyg 63:1, s. 180-190q 63:1<180-190x 0004-3591x 1529-0131
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:mau:diva-6496
856	4 8	u https://doi.org/10.1002/art.27766

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