title: Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Frank P
authors.initials: FP
authors.lastname: Strietzel
authors.forename: Gloria I
authors.initials: GI
authors.lastname: Lafaurie
authors.forename: Gloria R Bautista
authors.initials: GR
authors.lastname: Mendoza
authors.forename: Ivan
authors.initials: I
authors.lastname: Alajbeg
authors.forename: Slavica
authors.initials: S
authors.lastname: Pejda
authors.forename: Lea
authors.initials: L
authors.lastname: Vuletić
authors.forename: Rubén
authors.initials: R
authors.lastname: Mantilla
authors.forename: Denise P
authors.initials: DP
authors.lastname: Falcão
authors.forename: Soraya C
authors.initials: SC
authors.lastname: Leal
authors.forename: Ana C Barreto
authors.initials: AC
authors.lastname: Bezerra
authors.forename: Simon D
authors.initials: SD
authors.lastname: Tran
authors.forename: Henri A
authors.initials: HA
authors.lastname: Ménard
authors.forename: Suguru
authors.initials: S
authors.lastname: Kimoto
authors.forename: Shaoxia
authors.initials: S
authors.lastname: Pan
authors.forename: Rafael A
authors.initials: RA
authors.lastname: Martín-Granizo
authors.forename: M Lourdes Maniegas
authors.initials: ML
authors.lastname: Lozano
authors.forename: Susan L
authors.initials: SL
authors.lastname: Zunt
authors.forename: Cheryl A
authors.initials: CA
authors.lastname: Krushinski
authors.forename: Dario
authors.initials: D
authors.lastname: Melilli
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Campisi
authors.forename: Carlo
authors.initials: C
authors.lastname: Paderni
authors.forename: Sonia
authors.initials: S
authors.lastname: Dolce
authors.forename: Juan F
authors.initials: JF
authors.lastname: Yepes
authors.forename: Liselott
authors.initials: L
authors.lastname: Lindh
authors.forename: Meltem
authors.initials: M
authors.lastname: Koray
authors.forename: Gonca
authors.initials: G
authors.lastname: Mumcu
authors.forename: Sharon
authors.initials: S
authors.lastname: Elad
authors.forename: Itai
authors.initials: I
authors.lastname: Zeevi
authors.forename: Beatriz C Aldape
authors.initials: BC
authors.lastname: Barrios
authors.forename: Rodrigo M
authors.initials: RM
authors.lastname: López Sánchez
authors.forename: Ben Z
authors.initials: BZ
authors.lastname: Beiski
authors.forename: Andy
authors.initials: A
authors.lastname: Wolff
authors.forename: Yrjö T
authors.initials: YT
authors.lastname: Konttinen
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa; D011446:Prospective Studies; D012720:Severity of Illness Index; D012859:Sjogren's Syndrome / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome; D014987:Xerostomia / Q000209:etiology / Q000628:therapy*