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Efficacy and safety...
Efficacy and safety of an intraoral electrostimulation device for xerostomia relief : A multicenter randomized trial
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Strietzel, Frank P (author)
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Lafaurie, Gloria I (author)
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Bautista Mendoza, Gloria R (author)
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Alajbeg, Ivan (author)
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Pejda, Slavica (author)
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Vuleti?, Lea (author)
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Mantilla, Rubén (author)
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Falcão, Denise P (author)
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Leal, Soraya C (author)
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Barreto Bezerra, Ana C (author)
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Tran, Simon D (author)
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Ménard, Henri A (author)
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Kimoto, Suguru (author)
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Pan, Shaoxia (author)
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Martín-Granizo, Rafael A (author)
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Maniegas Lozano, M Lourdes (author)
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Zunt, Susan L (author)
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Krushinski, Cheryl A (author)
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Melilli, Dario (author)
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Campisi, Giuseppina (author)
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Paderni, Carlo (author)
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Dolce, Sonia (author)
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Yepes, Juan F (author)
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- Lindh, Liselott (author)
- Malmö högskola,Odontologiska fakulteten (OD)
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Koray, Meltem (author)
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Mumcu, Gonca (author)
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Elad, Sharon (author)
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Zeevi, Itai (author)
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Aldape Barrios, Beatriz C (author)
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López Sánchez, Rodrigo M (author)
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Beiski, Ben Z (author)
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Wolff, Andy (author)
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Konttinen, Yrjö T (author)
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(creator_code:org_t)
- 2010-12-28
- 2011
- English.
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In: Arthritis and Rheumatism. - : Wiley. - 0004-3591 .- 1529-0131. ; 63:1, s. 180-190
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Odontologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Dentistry (hsv//eng)
Keyword
- xerostomia
- dry mouth
- salivary gland hypofunction
- saliva
- electrical stimulation
- electrostimulation
- Sjögren’s syndrome
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Strietzel, Frank ...
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Lafaurie, Gloria ...
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Bautista Mendoza ...
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Alajbeg, Ivan
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Pejda, Slavica
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Vuleti?, Lea
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show more...
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Mantilla, Rubén
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Falcão, Denise P
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Leal, Soraya C
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Barreto Bezerra, ...
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Tran, Simon D
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Ménard, Henri A
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Kimoto, Suguru
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Pan, Shaoxia
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Martín-Granizo, ...
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Maniegas Lozano, ...
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Zunt, Susan L
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Krushinski, Cher ...
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Melilli, Dario
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Campisi, Giusepp ...
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Paderni, Carlo
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Dolce, Sonia
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Yepes, Juan F
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Lindh, Liselott
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Koray, Meltem
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Mumcu, Gonca
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Elad, Sharon
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Zeevi, Itai
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Aldape Barrios, ...
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López Sánchez, R ...
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Beiski, Ben Z
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Wolff, Andy
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Konttinen, Yrjö ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Dentistry
- Articles in the publication
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Arthritis and Rh ...
- By the university
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Malmö University