Scientific articles about Saliwell device. Four of them can be downloaded due to the absence of copyright issues.
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. Download PDF file.
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.
Conclusion. The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11 month period.
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.
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.
- Lafaurie G et al. Biotechnological advances in neuro-electro-stimulation for the treatment of hyposalivation and xerostomia. Med Oral Patol Oral Cir Bucal, 2009;14(2):E76-80. Download PDF file.
- Fedele S et al. Neuro-electrostimulation in the treatment of hyposalivation and xerostomia in Sjögren’s syndrome: a salivary pacemaker. Journal of Rheumatology, 2008;35(8):1489-1494. Download PDF file.
Strietzel FP et al. Electrostimulating device in the management of xerostomia. Oral Diseases, 2007; 13: 206–213
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 side effects were observed.
- 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. [Epub ahead of print] Download pdf file.
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. Results: Six patients were included in this series. Most of the intraoral areas with manifestations of cGVHD were not in contact with the GenNarino device. Two patients developed mild mucosal lesions in areas in contact with the GenNarino during the study. However, only one of them had a change in the National Institutes of Health (NIH) score for oral cGVHD. The unstimulated and stimulated salivary flow rate increased in 4 out of the 5 patients included in this analysis. Symptoms of dry mouth and general oral comfort improved. Conclusion: This study suggests that GenNarino is safe in cGVHD patients with respect to oral tissues. Furthermore the use of GenNarino resulted in subjective and objective improvements in dry mouth symptoms. A large scale study is needed to confirm the impact and safety of GenNarino on systemic cGVHD.