Medical Devices for the Treatment of Xerostomia

 

 

Background information on Xerostomia

Biotechnical Innovation

  • An intraoral device for electrostimulation of salivary glands has been developed to treat dry mouth. Saliwell GenNarino® (Saliwell Ltd., Harutzim, Israel) is a removable appliance similar to a mouthguard, combining microelectronics, software and wireless communication
  • Intraoral delivery of low-current electrostimulation has the potential to relieve symptoms of dry mouth (xerostomia) by increasing oral wetness
  • Natural saliva secretion is increased by electro-stimulation. The device works by sending electrical pulses of very low intensity (which is not discerned by the patient) to the lingual nerve. Since salivary glands are stimulated by the lingual nerve, the application of stimulating signals on this nerve leads to enhanced salivary secretion
  • The salivary electro-stimulator (a customised removable appliance) is composed of a thermoplastic polyurethane material and a tiny electronic stimulating device that contains a signal generator (electrodes), a battery and a circuit that is contained within the plastic splint. The electrodes are located on the third molar area mucosa to permit stimulation of the lingual nerve. The electro-stimulator is customised for each patient once a working model is obtained
  • A handheld  remote control unit is used to turn the device on and off
  • The distance between the lingual nerve and the surface of the oral mucosa that is in contact with the electrodes can vary between 1.0-5.0 mm. In addition to the lingual nerve, the long buccal nerve also runs next to GenNarino’s electrodes. As a result of exciting these nerves, all salivary glands are stimulated by the salivary reflex

Some points to note with the use of the GenNarino are:

  1. In head and neck irradiated patients, the electrodes should be placed in the side that is opposite to the irradiated site. Irradiated patients and those treated with bisphosphonates must avoid developing irritation-originated lesions. If mucosal ulceration occurs, the lesion must heal before the device can be worn
  2. This appliance can replace drug therapy. More serious cases may also need sialagogues, particularly patients with dry eye
  3. Optimal levels of fluoride in toothpastes and mouthwashes should be maintained in combination with the use of the appliance
  4. Once every two years, a new GenNarino needs to be fabricated with fresh batteries. There are no side effects to the electricity. Double blind placebo controlled clinical trials have demonstrated a significant increase in saliva secretion and relief to the patients