SALIWELL DRY MOUTH SOLUTION RESEARCH PAPERS
ABSTRACTS OF RESEARCH PAPERS DONE ON XEROSTOMIA
Med Oral Patol Oral Cir Bucal. 2009 Feb 1;14 (2):E76-80. Electro-stimulation in xerostomia
Journal section: Oral Medicine and Pathology
Publication Types: Review
Biotechnological advances in neuro-electro-stimulation for the treatment of
hyposalivation and xerostomia
Gloria Lafaurie 1, Stefano Fedele 2, Rafael Martín-Granizo López 3, Andy Wolff 4, Frank Strietzel 5, Stephen
R. Porter 6, Yrjö T. Konttinen 7
1 Director, Institute UIBO (Unit of Basic Oral Investigation), Dental Faculty, El Bosque University. Bogotá, Colombia
2 Clinical Lecturer, Oral Medicine and Special Needs Dentistry Unit, Division of Maxillofacial Diagnostic, Medical and Surgical
Sciences, Eastman Dental Institute UCL, London, United Kingdom
3 Oral and Maxillofacial Surgeon. Department of Oral and Maxillofacial Surgery. Hospital Clinico San Carlos, Madrid, Spain
4 Saliwell Ltd y Assuta Hospital, 2 Hatamar St., Harutzim 60917, Israel
5 Charité – Medical University Berlin. CharitéCentre 3 for Dental Medicine. Department for Oral Medicine, Dental Radiology
and Oral Surgery. Berlin. Germany
6 Academic Head, Oral Medicine and Special Needs Dentistry Unit, Division of Maxillofacial Diagnostic, Medical and Surgical
Sciences, Eastman Dental Institute UCL Professor of Oral Medicine, University of London, London, United Kingdom
7 Professor of Medicine, Institute of Clinical Medicine, Department of Medicine, University of Helsinki, Helsinki; Research
Director, ORTON Orthopaedic Hospital of the Invalid Foundation, Helsinki; Research Director, COXA Hospital for Joint
Replacement, Tampere, Finlandia
Correspondence:
Dr. Andy Wolff
Harutzim 60917
Israel
awolff@zahav.net.il
Received: 13/04/2008
Accepted: 11/06/2008
Lafaurie G, Fedele S, Martín-Granizo-López R, Wolff A, Strietzel F,
Porter SR, Konttinen YT. Biotechnological advances in neuro-electrostimulation
for the treatment of hyposalivation and xerostomia. Med
Oral Patol Oral Cir Bucal. 2009 Feb 1;14 (2):E76-80.
http://www.medicinaoral.com/medoralfree01/v14i2/medoralv14i2p76.pdf
Abstract
Treatment of xerostomia is a common clinical challenge in the oral medicine practice. Although some treatments
have been used to improve the symptoms of xerostomia, none is completely satisfactory for the patients who suffer
of this alteration. In the last years non-pharmacological treatments based on electro-stimulation for the treatment
of xerostomia have been developed. This review is aimed at presenting new developments for the treatment
of xerostomia, applying neuro-electro-stimulation by miniaturized intra-oral electro-stimulators. These devices
increase salivary secretion and improve symptoms of oral dryness. Their effect is obtained by means of stimulation
of the lingual nerve, in whose proximity the electrodes of the apparatus are placed. The objective of this
mechanism is both to directly stimulate the salivary glands controlled by that nerve and to enhance the salivary
reflex. Clinical studies have been carried out that have demonstrated the wetting effect of the method described
in this article.
Key words: Xerostomia, electro-stimulation, hyposalivation, saliva, dry mouth.
ARTHRITIS & RHEUMATISM
Vol. 63, No. 1, January 2011, pp 180–190
DOI 10.1002/art.27766
© 2011, American College of Rheumatology
Efficacy and Safety of an Intraoral Electrostimulation Device
for Xerostomia Relief
A Multicenter, Randomized Trial
Frank P. Strietzel,1 Gloria I. Lafaurie,2 Gloria R. Bautista Mendoza,2 Ivan Alajbeg,3
Slavica Pejda,3 Lea Vuletic´,3 Rube´n Mantilla,4 Denise P. Falca˜o,5 Soraya C. Leal,5
Ana C. Barreto Bezerra,5 Simon D. Tran,6 Henri A. Me´nard,7 Suguru Kimoto,8 Shaoxia Pan,9
Rafael A. Martı´n-Granizo,10 M. Lourdes Maniegas Lozano,10 Susan L. Zunt,11
Cheryl A. Krushinski,11 Dario Melilli,12 Giuseppina Campisi,12 Carlo Paderni,12 Sonia Dolce,12
Juan F. Yepes,13 Liselott Lindh,14 Meltem Koray,15 Gonca Mumcu,16 Sharon Elad,17
Itai Zeevi,17 Beatriz C. Aldape Barrios,18 Rodrigo M. Lo´pez Sa´nchez,18 Ben Z. Beiski,19
Andy Wolff,19 and Yrjo¨ T. Konttinen20
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 Sjo¨gren’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
ClinicalTrials.gov identifier: NCT00509808.
Drs. Tran and Me´nard’s work was supported by funding from
the Canadian Institutes of Health Research to McGill University
(CIHR Program to Stimulate International Research Initiatives). Dr.
Lindh’s work was supported by funding from the Swedish Laryng
Foundation to Malmo¨ University. Dr. Konttinen’s work was supported
by funding from the Academy of Finland, Finska La¨karesa¨llskapet,
Helsinki University Central Hospital, and the ORTON Foundation to
the University of Helsinki. Saliwell Ltd. (Harutzim, Israel) provided
the intraoral electrostimulation devices for the study at no charge.
1Frank P. Strietzel, MD, DDS: Charite´ Universita¨tsmedizin
Berlin, Berlin, Germany; 2Gloria I. Lafaurie, DDS, Gloria R. Bautista
Mendoza, MS Statistics: Universidad El Bosque, Bogota´, Colombia;
3Ivan Alajbeg, DMD, PhD, Slavica Pejda, DDM, Lea Vuletic´, DMD:
University of Zagreb, Zagreb, Croatia; 4Rube´n Mantilla, MD: Clı´nica
de Artritis y Rehabilitacio´n, Bogota´, Colombia; 5Denise P. Falca˜o,
MHS, Soraya C. Leal, PhD, Ana C. Barreto Bezerra, DMD, PhD:
Universidade de Brasilia, Brasilia, Brazil; 6Simon D. Tran, DMD,
PhD: McGill University, Montreal, Quebec, Canada; 7Henri A. Me´-
nard, MD: McGill University and McGill University Health Center,
Montreal, Quebec, Canada; 8Suguru Kimoto, DDS, PhD: Nihon
University School of Dentistry at Mastudo, Mastudo, Japan; 9Shaoxia
Pan, DMD: Hospital of Stomatology and Peking University, Beijing,
China; 10Rafael A. Martı´n-Granizo, MD, M. Lourdes Maniegas
Lozano, MD, DMD: Hospital Clı´nico San Carlos, Madrid, Spain;
11Susan L. Zunt, DDS, MS, Cheryl A. Krushinski, DDS: Indiana
University, Indianapolis; 12Dario Melilli, DMD, Giuseppina Campisi,
DMD, PhD, Carlo Paderni, DMD, Sonia Dolce, DMD: Universita` di
Palermo, Palermo, Italy; 13Juan F. Yepes, DDS, MD, MPH: University
of Kentucky, Lexington; 14Liselott Lindh, DDS, PhD: Malmo¨ University,
Malmo¨, Sweden; 15Meltem Koray, DDS, PhD: Istanbul University,
Istanbul, Turkey; 16Gonca Mumcu, DDS, PhD: University of
Marmara, Istanbul, Turkey; 17Sharon Elad, DMD, MSc, Itai Zeevi,
DMD: Hebrew University Hadassah School of Dental Medicine,
Jerusalem, Israel; 18Beatriz C. Aldape Barrios, DDS, Rodrigo M.
Lo´pez Sa´nchez, DDS: Universidad Nacional Auto´noma de Mexico,
Mexico City, Mexico; 19Ben Z. Beiski, MS, Andy Wolff, DMD: Saliwell
Ltd., Harutzim, Israel; 20Yrjo¨ T. Konttinen, MD, PhD: Helsinki
University Central Hospital, University of Helsinki, and ORTON
Orthopaedic Hospital, Helsinki, and COXA Hospital for Joint Replacement,
Tampere, Finland.
Dr. Zunt served as principal investigator in a study funded by
Parion Sciences. Mr. Beiski and Dr. Wolff own stock in Saliwell Ltd.
and hold patents as coinventors of intraoral electronic medical devices.
Address correspondence to Andy Wolff, DMD, Saliwell Ltd.,
65 Hatamar Street, Harutzim 60917, Israel. E-mail: awolff@zahav.
net.il.
Submitted for publication April 14, 2010; accepted in revised
form September 21, 2010.
180
The Burden of Xerostomia in Independent
Community-dwelling Older Adults:
Results from the Saliwell Project
Laxman Nayaka, AndyWolffb, Stefano Fedelec, Rafael Martin-Granizod, Peter A. Reicharte,
Lucio Lo Russoc, Michele Mignognac, Frank Strietzele, and the Saliwell Study Group
aCentre for Applied Gerontology, University of Birmingham, Birmingham, UK.
bHospital Dentistry Department, Assuta Hospital, Tel Aviv, Israel.
cOral Medicine Section, Department of Odontostomatological and Maxillofacial Sciences, University ‘‘Federico II’’ of
Naples, Naples, Italy.
dOral and Maxillofacial Surgery Department, Hospital Clinico San Carlos, Madrid, Spain.
eOral Surgery, CharitØ-UniversitWtsmedizin Berlin, Berlin, Germany.
fThe Saliwell Study Group includes the following researchers: Ben Z. Beiski from Assuta Hospital, Tel Aviv; Amichay Ziv,
Eitan Hod and David Alon from Aran, Tel Aviv; Eytan Ofry and Yael Shklarsky from Relsoft, Tel Aviv; Oliver Scholz, Thomas
Velten, Klaus Peter Koch and Oliver Steinmetz from Fraunhofer Institute, St. Ingbert, Germany; Michael Rinck from MTPromedt,
St. Ingbert, Germany; Hakan Lindstrom from Nobel Biocare, Goteborg, Sweden; Philippe Clot and Stephan Kolly
from Valtronic SA, Les Charbonnieres, Switzerland.
Purpose: The Saliwell Project was a European Research Consortium initiative aimed at developing an intraoral device to treat dry
mouth by electroneurostimulation. The purpose of the present study was to evaluate the burden of xerostomia in independent
community-dwelling older adults using quantitative and qualitative analyses, as a preliminary phase of the project.
Materials and Methods: A cross-sectional postal questionnaire survey was carried out involving 1,000 adults aged 60 years
and above, randomly selected from the Birmingham University Thousand Elders database. The questionnaire format was
designed at two focus groups’ meetings involving people with chronic xerostomia. Age, gender, chronic medical conditions
and number of prescribed medications consumed daily, as well as dental, oral and general health status, Geriatric Oral Health
Assessment Index (GOHAI), Xerostomia Inventory (XI), chewing capability and dry mouth questions were evaluated.
Results: Seven hundred and seventy completed questionnaires were available for analyses. There were 274 males and 496
females (age range 60 to 85). The overall prevalence of xerostomia (subjective complaints of dry mouth) was 15.5%. A
logistic regression analysis showed that the following factors significantly (P_0.05) contributed to xerostomia: gender; number
of prescribed medications; complaints of anxiety, digestive, bladder and osteoporosis problems; oral health satisfaction
level and perceived general health status.
Conclusions: The overall prevalence of xerostomia as well as its risk factors was in agreement with the previously published
studies. Since chronic xerostomia is a distressing disorder with significant impact on oral health satisfaction and general health
status, a comprehensive treatment of xerostomia should carefully consider patients’ perspectives and behaviours.
Key words: Xerostomia, older adults, GOHAI, XI
Oral Biosci Med 2004; 4: 00-00 Submitted for publication 6 August 2004; accepted for publication 8 November 2004.
INTRODUCTION
Xerostomia has frequently been associated with salivary
gland hypofunction and concomitant loss in the
quality of life for sufferers (Fox et al, 1987; Sreebny
Vol 4,
Oral Diseases (2007) 13, 206–213. doi:10.1111/j.1601-0825.2006.01268.x
_ 2006 Blackwell Munksgaard All rights reserved
http://www.blackwellmunksgaard.com
ORIGINAL ARTICLE
Electrostimulating device in the management
of xerostomia
FP Strietzel1, R Martı´n-Granizo2, S Fedele3,5, L Lo Russo3, M Mignogna3, PA Reichart1, A Wolff4
1Abteilung fu¨r Oralchirurgie und Zahna¨rzliche Ro¨ntgenologie, Charite´ – Universita¨tsmedizin Berlin, Campus Virchow-Klinikum,
Germany; 2Servicio de Cirugla Oral y Maxilofacial, Hospital Clı´nico San Carlos, Madrid, Spain; 3Dipartmento di Scienze
Odontostamatologiche e Maxillo-Facciali, Universita` di Napoli Federico II, Italy; 4Saliwell Ltd, Assuta Hospital, Tel Aviv, Israel;
5Oral Medicine Unit, Eastman Dental Institute for Oral Health Care Sciences, University of London, UK
INTRODUCTION: The present study was undertaken to
evaluate the safety and effectiveness of a recently developed
electrostimulating device mounted on an individualized
intra-oral removable appliance.
MATERIALS AND METHODS: The device, containing
electrodes, a wetness sensor, an electronic circuit and a
power source, was tested on patients with xerostomia in a
crossover, randomized, sham-controlled, double-blinded,
multicenter study. Electrical stimulation and also sham
were delivered during 10 min to the oral mucosa, in the
mandibular third molar region. Oral dryness was measured
by the sensor. As the primary outcome, sensor dryness
and xerostomia symptom changes as a result of device
wearing were assessed, and compared between active and
sham modes. In addition, side-effects were recorded.
RESULTS: Electrostimulation resulted in a significant
decrease in sensor dryness, leading to a beneficial effect
on patients’ subjective condition. No significant sideeffects
were observed.
Oral Diseases (2007) 13, 206–213
