New devices for people who suffer dry mouth or lack of saliva

Dec 2 2004

For dry mouth sufferers Saliwell’s innovative patented devices brings welcome relief by restoring natural saliva production through electro-stimulation.

Most of us may suffer dry mouth from time to time. But for 80 million people in the developed world it is a permanent condition caused by a lack of lubrication in the mouth. With IST programme funding Saliwell has developed devices that stimulate saliva production. “Our devices apply a low energy level of electricity to the right nerves that lead to a higher level of saliva secretion,” says Dr Andy Wolff, Saliwell project coordinator at Assuta Medical Centers in Israel.

Their removable device, GenNarino, is custom made which sufferers wear whenever they need it. 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 the Saliwell tester and recharger, and returns the GenNarino once a year to the manufacturer to fabricate a new one or install fresh batteries, offering a kind of permanent service.

There are no side affects to the electricity and they are now conducting double blind placebo controlled clinical trials. After about 200 experiments they have found a significant increase in saliva secretion and relief to the patients.

Alongside the clinical trials there have been questionnaires. The findings are positive with no complaints, despite it being a prosthetic that fits in the mouth, says Wolff. As an added bonus, users claim that it alleviates the problem of dry eyes, an ailment that also commonly afflicts dry mouth sufferers.

Wolff hopes they can market the GenNarino next year once it gets the CE mark. They first want to commercialise it themselves and then merge with a larger company which, for example, supplies medical devices.

Another solution 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.

After getting ethics committee permission trials on the Crown are about to begin in three different independent centres in Berlin, Madrid and Naples.

Both the GenNarino and the Saliwell Crown have been patented.

As for the causes of dry mouth, 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 medicine. Once afflicted it remains for the rest of the life.

As a result as Wolff explains: “It disturbs their speech, their swallowing, tasting, it wakes them up during the night, causes increased tooth decay, and it also makes it difficult to wear dentures.” Wolff says current solutions are less than adequate relying mainly on expensive drugs that cause adverse side affects.

In addition, continues Wolff, it can have negative social side effects. With dry mouth it is harder to communicate so people become reclusive. Difficulties in sleeping means they also become tired and lacklustre.

In the UK 1000 elderly people were interviewed about their expectations for such a device. In this survey 15.5% have dry mouth. In looking for a solution, “they expect a non-chemical solution that could permanently solve their problem without having to resort to drugs,” says Wolff. “We hope we have fulfilled their expectations,” concludes Wolff.

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