Clinical Evidence

Read what the professionals say about SaliPen for Dry Mouth relief

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Medical experts about SaliPen – the best Dry Mouth cure available

SaliPen amazed medical professionals who had no proper Dry Mouth relief and treatment for their patients, until SaliPen came to be the best dry mouth remedy available today

"...SaliPen has been greatly received..."

I give patients information on management of salivary hypofunction / xerostomia and include your excellent device and include the website link for further information and ordering.

SaliPen has been greatly received by my patients in Australia.

Dr. Anastasia Georgiou, Oral Medicine Specialist, President of the Oral Medicine Academy of Australasia
Sydney Skin, 100 Carillon Avenue, Newtown, Australia, Macquarie OMS, 135 Macquarie Street, Sydney, Australia

"...excellent medical device..."

I have been treating patients with dry mouth for many years. The SaliPen is an excellent medical device to stimulate salivary flow.  As such, I am now prescribing it to my patients that suffer from dry mouth.

The SaliPen is especially valuable for the patient who cannot tolerate salivary stimulant medication. Nevertheless, it can be used alone or as an adjunct to salivary stimulant medication or to local agents like mouthwashes, lozenges, gels, etc.

Susan Zunt, DDS, MS., Professor and Chair – Department of Oral Pathology, Medicine and Radiology, Indiana University School of Dentistry, USA

"...very satisfied with SaliPen performance..."

Meanwhile Mrs. H. has received  her SaliPen from customs. I was told by Mr. H. that she is very satisfied with the performance of the SaliPen.

Dr. F.P.S., Germany

"...patients are very happy...."

The microstimulator is great and the patients are very happy.

Prof. Beatriz Aldape Barrios, Department of Oral Pathology and Histology, Embryology and Genetics, Universidad Nacional Autonoma de Mexico

"...the best thing on earth..."

Patient has Sjögren’s Syndrome, and sees your device as the best thing on earth.

Dr. Jeffrey A. Oras, private practice, New Jersey, USA

"...massive impact on patients’ quality of life..."

“The SaliPen sends out little electric impulses through to the salivary glands, triggering them to produce saliva. It’s so subtle you can’t feel it.
It has a massive impact on patients’ quality of life.”

Suzannah Pegler, lead research practitioner at the Marlborough Road hospital, U.K. (source: swindonadvertiser.co.uk)

"...My Sjögren’s patient is so much better..."

My Sjögren’s patient is so much better. She went back to teaching and has no problem during class anymore.

Prof. Ilana Kaplan, Israel, Director Oral Pathology Services, Rabin Medical Center,  Petach Tiqva; Director, Oral Pathology Services, Tel-Aviv Sourasky Medical Center, Tel-Aviv; Senior lecturer, Department of Pathology, School of Medicine, Tel-Aviv University, Israel

"...worked wonderfully..."

The appliance worked wonderfully well to reduce the symptoms of her Sjögren’s syndrome.

Dr. Richard L. Cohen, private practice, Ohio, USA

"...my patient is very happy..."

From the very beginning it worked properly and my patient is very happy.

Dr. Matthias Konietzny, private practice, Berlin, Germany

"...the idea of a nerve stimulation device is good..."

I think the idea of a nerve stimulation device is good, since there is no ideal saliva substitute in the market.

Dr. Samira Osailan, Department of Oral Pathology Salivary Research Unit, Guy’s Hospital, London, UK

Scientific articles about the SaliPen device

The following articles researched how Saliwell devices successfully treat Dry Mouth by electrostimulation

Conclusion:

The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11 month period.

Alajbeg I et al. Intraoral electrostimulator for xerostomia relief – a long-term multicenter open-label uncontrolled clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol, 2012;113:773-781.

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.

Strietzel FP et al. Efficacy and Safety of an Intraoral Electrostimulation Device for Xerostomia Relief: A Multicenter Randomized Trial. Arthritis & Rheumatism, 2011;63:180–190.

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).

Conclusion:

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.

Conclusion:

Electrostimulation resulted in a significant decrease in sensor dryness, leading to a beneficial effect on patients’ subjective condition. No significant side effects were observed.

Strietzel FP et al. Electrostimulating device in the management of xerostomia. Oral Diseases, 2007; 13: 206–213

Abstract:
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.

Wolff A et al. Electrostimulation of the lingual nerve by an intraoral device may lead to salivary gland regeneration: A case series study. Med Oral Patol Oral Cir Bucal, 2018; 23(5): e552-e559

Abstract:
Background:
Salivary gland function is controlled by the salivary reflex, whose efferent arm is composed by the parasympathetic and the sympathetic divisions of the autonomic nervous system. Parenchymal injury is the main salivary gland involvement of Sjögren’s syndrome and head and neck radiotherapy, but neural damage has been reported as well. Recently an intraoral device for electrostimulation of the lingual nerve in vicinity to the lower third molar has been introduced. At this point this nerve carries efferent fibers for the innervation of the submandibular, sublingual and several minor salivary glands and afferent fibers of the salivary reflex. Therefore, excitation of these fibers potentially leads to increased secretion of all salivary glands. Thus, the study objective was to assess whether comprehensive neural activation by electrostimulation of the lingual nerve carries the potential to induce the regeneration of damaged salivary glands.

Materials and methods:
The device was tested on three patients with no collectable resting and stimulated secretion of saliva during a double blind, sham controlled period of two months and nine open-label months.

Results:

All three subjects developed the capacity to spit saliva, not only in direct response to the electrostimulation but also after free intervals without electrostimulation.

In addition, their symptoms of dry mouth severity and frequency improved.

Conclusion:

…clinical studies have shown that in patients without any salivary output lingual nerve stimulation led to regaining their ability to spit saliva

Dr. Andy Wolff. Electrostimulator and xerostomia. Dentaltown website. Retrieved February 2019.

Abstract:
…at the end of the trial other subjective parameters such as oral discomfort, speech difficulty, frequency of waking at night and the rate of salivary flow (both unstimulated and stimulated by mastication) had improved.

Zadik Y et al. Safety and efficacy of an intra-oral electrostimulator for the relief of dry mouth in patients with chronic graft versus host disease: Case Series. Med Oral Patol Oral Cir Bucal, 2013 Oct 13.

Abstract:
Objectives: Patients with chronic graft-versus-host disease (cGVHD) often suffer from dry mouth and oral mucosal lesions. The primary objective of this study was to investigate the safety of an intra-oral electrostimulator (GenNarino) in symptomatic cGVHD patients. The secondary objective was to study the impact on the salivary gland involvement of cGVHD patients. Study Design: This paper presents a case series. The study included patients treated for 4 weeks, randomly assigned to the active device and then crossed-over to a sham-device or vice versa. The patients and clinicians were blind to the treatment delivered. Data regarding oral mucosal and salivary gland involvement were collected. 

Conclusion:

…the use of GenNarino* resulted in subjective and objective improvements in dry mouth symptoms

*GenNarino is an earlier generation device utilizing similar technologies as SaliPen does.

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Saliwell in Israel

Saliwell Ltd.
3A Hatamar St.
Harutzim 60917
Israel

Phone: +972-50-880-1852

Phone: +972-50-725-6338

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Saliwell Ltd.
Gewerbepark Eschbergerweg,
Im Helmerswald 2, Gebäude 4,
66121 Saarbrücken
Germany

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