Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial.
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.


METHODS
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.
Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.
Ivan
I
Alajbeg
Denise P
DP
Falcão
Simon D
SD
Tran
Rafael
R
Martín-Granizo
Gloria I
GI
Lafaurie
Domenica
D
Matranga
Slavica
S
Pejda
Lea
L
Vuletić
Rubén
R
Mantilla
Soraya C
SC
Leal
Ana C Barreto
AC
Bezerra
Henri A
HA
Ménard
Suguru
S
Kimoto
Shaoxia
S
Pan
Lourdes
L
Maniegas
Cheryl A
CA
Krushinski
Dario
D
Melilli
Giuseppina
G
Campisi
Carlo
C
Paderni
Gloria R Bautista
GR
Mendoza
Juan F
JF
Yepes
Liselott
L
Lindh
Meltem
M
Koray
Gonca
G
Mumcu
Sharon
S
Elad
Itai
I
Zeevi
Beatriz C Aldape
BC
Barrios
Rodrigo M
RM
López Sánchez
Claire
C
Lassauzay
Olivier
O
Fromentin
Ben Z
BZ
Beiski
Frank P
FP
Strietzel
Yrjö T
YT
Konttinen
Andy
A
Wolff
Susan L
SL
Zunt
D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D003680:Deglutition Disorders / Q000628:therapy; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016013:Likelihood Functions; D008036:Lingual Nerve / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012463:Saliva / Q000378:metabolism; D012636:Secretory Rate; D012893:Sleep Wake Disorders / Q000628:therapy; D013064:Speech Disorders / Q000628:therapy; D013813:Therapy, Computer-Assisted / Q000295:instrumentation*; D013997:Time Factors; D016896:Treatment Outcome; D014987:Xerostomia / Q000628:therapy*; D055815:Young Adult