Electronic Intra-Oral Device to Treat Xerostomia: A Multinational Study

Objectives: A European Commission funded project (“Saliwell”) has developed an intra-oral electro-stimulator of salivary glands to treat dry mouth. The device, named “GenNarino”, is a removable appliance, combining micro-electronics, software and wireless communication, and applies stimulating signals on the lingual nerve, leading to enhanced salivary secretion. By doing so, the objective is to execute the most efficient means to treat dry mouth and its consequences, as natural saliva not only relieves dryness; it also contains essential dental decay-fighting factors and other components critical for oral health. A short-term clinical trial has shown statistically significant improvement in patients' oral wetness and symptoms, and no side-effects (Strietzel FP et al., 2007). The objective of the present study is to test the efficacy of the device over a period of several months.

Methods: In this randomized multi-national clinical trial, the use of the device is compared between active vs sham mode for one month each in a double-blind design. Thereafter, the xerostomia relieving effect is compared between different lengths of usage (1, 5 or 10 minutes) of the active device, for additional 9 months. VAS-based questionnaires and whole saliva collections are performed. At least 100 xerostomia patients will be evaluated.

Results: Data of the first 50 patients show improvement in a variety of parameters, such as quality of life and sleeping, oral dryness and comfort, speech, swallowing and salivary flow-rate. On patients with very low or absent flow-rate at baseline, the superiority of active over sham is the greatest.

Conclusions: These results are confirming the efficacy of GenNarino in the relief of xerostomia.

Acknowledgements: The study has started at the Universities of El Bosque (Bogotá), Hadassah (Jerusalem), Istanbul, Kentucky, Malmö, Mc Gill (Montreal), Palermo, UNAM (Mexico), Zagreb, Brasilia and the Hospitals Charité (Berlin) and Clínico San Carlos (Madrid).