• 2/28/2005
  • David Brinn
  • Israel21c (www.israel21c.org

Most of us may suffer dry mouth from time to time. But for 80 million people in the developed world who suffer from the condition – technically known as xerostomia – it is a permanent condition caused by a lack of lubrication in the mouth

Now an Israeli undertaking – under the project name Saliwell – has developed a removable device called the GenNarino that stimulate saliva production through electro-stimulation.

“Our devices apply a low energy level of electricity to the right nerves that lead to a higher level of saliva secretion,” explained Dr Andy Wolff, Saliwell project coordinator at Assuta Medical Centers in Israel.

Xerostomia is defined as the subjective feeling of dry mouth and is frequently associated with a reduction in salivary glands function.. It’s a chronic and mostly irreversible condition induced as a side effect by over 500 types of medication used to treat chronic diseases (like hypertension, depression, etc.), and by radiation therapy for head & neck cancer patients. Xerostomia also is a typical symptom of some auto-immune diseases (Sjögren?s syndrome is the most prominent) and other conditions.

According to Wolff, salivary glands malfunction in the mouth for a number of reasons. These include diseases such as autoimmune diseases and diabetes, treatments like chemotherapy, radiation therapy or from the side effects of medication. Those who are afflicted have the condition for life.

They endure the many unpleasant aspects of xerostomia. “It disturbs their speech, their swallowing, tasting,” explains Wolff. “It wakes them up during the night, causes increased tooth decay, and it also makes it difficult to wear dentures.” In addition, he continues, it can have negative social side effects.

Saliwell’s solution is based on applying stimulating signals on the salivary glands associated nerves, causing the salivary glands to naturally and constantly secrete saliva at an enhanced capacity. As demonstrated by the famous researcher Pavlov, secretion of saliva increases sharply as a result of a stimulus (food in his experiments).

Saliwell devices apply this principle and by mimicking natural stimulation, achieve the same effect of increased salivation, which is the most efficient means to relieve xerostomia. Natural saliva not only relieves dryness; it also contains essential dental decay-fighting factors and other components critical for oral health.

According to Wolff, Saliwell’s process turns a dry mouth into a moist one rather quickly. Dentists make an impression of the patient’s mouth and send it to the manufacturer, which in turn embeds the circuitry between two sheets of dental material and returns the device to the dentist. The patient recharges the battery through the year using a Saliwell tester and recharger, and returns the GenNarino once a year to the manufacturer to fabricate a new one or install fresh batteries.

The importance of the Saliwell solution was acknowledged by the European Commission (EC) 5th Framework Program, which approved funding for the development of the device. The Saliwell Project was launched in July 2002, coordinated by Assuta Medical Centers, Tel Aviv, Israel, and with the participation of leading European technological and medical organizations.

About 200 double blind experiments were performed in three medical centers (Charité Hospital Berlin, Hospital Clínico San Carlos Madrid and Università di Napoli Federico II). The results are showing a statistically significant increase in salivation following electrical stimulation versus placebo, where no increase in salivation was detected.

“The trials showed there was a positive effect and people were satisfied with its use.
It just needs some final adjustments. We hope to have CE approval within 6 months and FDA approval sometime after that,” Wolff told ISRAEL21c.

To reassure those who are hesitant to place something electrical in their mouths, Wolff says that there are no side affects to the electricity. The patients were also asked to fill out a questionnaire. The findings were overwhelmingly positive, with no complaints, despite it being a prosthetic that fits in the mouth. As an added bonus, said Wolff, some users claim that it alleviates the problem of dry eyes, an ailment that also commonly afflicts dry mouth sufferers.

Wolff, the mastermind behind the GenNarino, began his’love affair’ with dry mouth when he spent three years at the National Institute of Health in Washington from 1986-89 at their National Institute of Dental Research.

“I was working in the oral biology department and the general focus was on dry mouth. Since there was no good solution, I’d been thinking about it ever since,” said Wolff, who has authored 40 articles and book chapters on salivary glands and xerostomia and owns a US patent for the Saliwell solution.

Since he established Saliwell, Wolff and his team have focused on a pioneering approach: the development of electronically based, intra-oral therapeutic and diagnostic devices. With the help of the latest developments in nanotechnology, electronic miniaturization and software, Wolff said that Saliwell is creating an intra-oral ‘intelligent ambient’, opening the doors to numerous innovative applications.

Wolff, who until May 2004, served as director of the Hospital Dentistry Department at Assuta, said that previous devices used to treat dry mouth failed due to their impracticality.

“There used to be a device called the Salitron about 15 or 20 years ago meant to treat dry mouth. But it was cumbersome, a big video appliance you had to carry around with you. It wasn’t practical. On the other hand, the GenNarino is the size of a tooth,” he said.

Likewise, he added, the multitudes of medications to treat the condition each have their own limitations.

“Dry mouth can be treated by medication, but its effects are limited by time, there are many restrictions to who can take it, and there are side effects,” Wolff said.

As opposed to the available treatments, Saliwell offers a permanent, effective, comfortable and side effect free treatment for xerostomia. According to Wolff, the device will reduce the expenses which patients and the medical services spend today to treat dry mouth and their damaged dentition.

And they’re not stopping with the GenNarino. Another solution to dry mouth that Saliwell is developing is their Saliwell Crown which is attached to a regular permanent dental implant. Their Crown can be simply inserted into an implant by any dentist familiar with implants. Since the Crown is screwed in, when the battery runs out it can be easily removed and replaced. This happens roughly once a year, according to Wolff.

Clinical trials are expected to take place during the year at independent centers in Berlin, Madrid and Naples.