Intraoral electrostimulator for xerostomia relief

A long-term, multicenter, open-label, uncontrolled, clinical trial

Ivan Alajbeg, Denise P. Falcão, Simon D. Tran, Rafael Martín-Granizo, Gloria I. Lafaurie, Domenica Matranga, Slavica Pejda, Lea Vuletić, Rubén Mantilla, Soraya C. Leal, Ana C Barreto Bezerra, Henri A. Ménard, Suguru Kimoto, Shaoxia Pan, Lourdes Maniegas, Cheryl A. Krushinski, Dario Melilli, Giuseppina Campisi, Carlo Paderni, Gloria R Bautista Mendoza & 15 others Juan Yepes, Liselott Lindh, Meltem Koray, Gonca Mumcu, Sharon Elad, Itai Zeevi, Beatriz C Aldape Barrios, Rodrigo M López Sánchez, Claire Lassauzay, Olivier Fromentin, Ben Z. Beiski, Frank P. Strietzel, Yrjö T. Konttinen, Andy Wolff, Susan Zunt

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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. Study Design. 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.

Original languageEnglish (US)
Pages (from-to)773-781
Number of pages9
JournalOral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Volume113
Issue number6
DOIs
StatePublished - Jun 2012

Fingerprint

Xerostomia
Clinical Trials
Equipment and Supplies
Lingual Nerve
Deglutition
Multicenter Studies
Outcome Assessment (Health Care)
Safety
Therapeutics

ASJC Scopus subject areas

  • Surgery
  • Oral Surgery
  • Pathology and Forensic Medicine
  • Radiology Nuclear Medicine and imaging
  • Dentistry (miscellaneous)

Cite this

Intraoral electrostimulator for xerostomia relief : A long-term, multicenter, open-label, uncontrolled, clinical trial. / Alajbeg, Ivan; Falcão, Denise P.; Tran, Simon D.; Martín-Granizo, Rafael; Lafaurie, Gloria I.; Matranga, Domenica; Pejda, Slavica; Vuletić, Lea; Mantilla, Rubén; Leal, Soraya C.; Bezerra, Ana C Barreto; Ménard, Henri A.; Kimoto, Suguru; Pan, Shaoxia; Maniegas, Lourdes; Krushinski, Cheryl A.; Melilli, Dario; Campisi, Giuseppina; Paderni, Carlo; Mendoza, Gloria R Bautista; Yepes, Juan; Lindh, Liselott; Koray, Meltem; Mumcu, Gonca; Elad, Sharon; Zeevi, Itai; Barrios, Beatriz C Aldape; Sánchez, Rodrigo M López; Lassauzay, Claire; Fromentin, Olivier; Beiski, Ben Z.; Strietzel, Frank P.; Konttinen, Yrjö T.; Wolff, Andy; Zunt, Susan.

In: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, Vol. 113, No. 6, 06.2012, p. 773-781.

Research output: Contribution to journalArticle

Alajbeg, I, Falcão, DP, Tran, SD, Martín-Granizo, R, Lafaurie, GI, Matranga, D, Pejda, S, Vuletić, L, Mantilla, R, Leal, SC, Bezerra, ACB, Ménard, HA, Kimoto, S, Pan, S, Maniegas, L, Krushinski, CA, Melilli, D, Campisi, G, Paderni, C, Mendoza, GRB, Yepes, J, Lindh, L, Koray, M, Mumcu, G, Elad, S, Zeevi, I, Barrios, BCA, Sánchez, RML, Lassauzay, C, Fromentin, O, Beiski, BZ, Strietzel, FP, Konttinen, YT, Wolff, A & Zunt, S 2012, 'Intraoral electrostimulator for xerostomia relief: A long-term, multicenter, open-label, uncontrolled, clinical trial', Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, vol. 113, no. 6, pp. 773-781. https://doi.org/10.1016/j.oooo.2012.01.012
Alajbeg, Ivan ; Falcão, Denise P. ; Tran, Simon D. ; Martín-Granizo, Rafael ; Lafaurie, Gloria I. ; Matranga, Domenica ; Pejda, Slavica ; Vuletić, Lea ; Mantilla, Rubén ; Leal, Soraya C. ; Bezerra, Ana C Barreto ; Ménard, Henri A. ; Kimoto, Suguru ; Pan, Shaoxia ; Maniegas, Lourdes ; Krushinski, Cheryl A. ; Melilli, Dario ; Campisi, Giuseppina ; Paderni, Carlo ; Mendoza, Gloria R Bautista ; Yepes, Juan ; Lindh, Liselott ; Koray, Meltem ; Mumcu, Gonca ; Elad, Sharon ; Zeevi, Itai ; Barrios, Beatriz C Aldape ; Sánchez, Rodrigo M López ; Lassauzay, Claire ; Fromentin, Olivier ; Beiski, Ben Z. ; Strietzel, Frank P. ; Konttinen, Yrjö T. ; Wolff, Andy ; Zunt, Susan. / Intraoral electrostimulator for xerostomia relief : A long-term, multicenter, open-label, uncontrolled, clinical trial. In: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. 2012 ; Vol. 113, No. 6. pp. 773-781.
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abstract = "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. Study Design. 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.",
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T2 - A long-term, multicenter, open-label, uncontrolled, clinical trial

AU - Alajbeg, Ivan

AU - Falcão, Denise P.

AU - Tran, Simon D.

AU - Martín-Granizo, Rafael

AU - Lafaurie, Gloria I.

AU - Matranga, Domenica

AU - Pejda, Slavica

AU - Vuletić, Lea

AU - Mantilla, Rubén

AU - Leal, Soraya C.

AU - Bezerra, Ana C Barreto

AU - Ménard, Henri A.

AU - Kimoto, Suguru

AU - Pan, Shaoxia

AU - Maniegas, Lourdes

AU - Krushinski, Cheryl A.

AU - Melilli, Dario

AU - Campisi, Giuseppina

AU - Paderni, Carlo

AU - Mendoza, Gloria R Bautista

AU - Yepes, Juan

AU - Lindh, Liselott

AU - Koray, Meltem

AU - Mumcu, Gonca

AU - Elad, Sharon

AU - Zeevi, Itai

AU - Barrios, Beatriz C Aldape

AU - Sánchez, Rodrigo M López

AU - Lassauzay, Claire

AU - Fromentin, Olivier

AU - Beiski, Ben Z.

AU - Strietzel, Frank P.

AU - Konttinen, Yrjö T.

AU - Wolff, Andy

AU - Zunt, Susan

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N2 - 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. Study Design. 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.

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