Research at UCL/UCLH led by Professor Fedele is set to revolutionise the treatment of chronic dry mouth, a common and distressing disorder caused by permanently reduced saliva production. In collaboration with industry and an international multidisciplinary consortium the investigators have developed, patented and tested a device that increases saliva production.
Following approval by regulatory agencies, a final trial is ongoing across several centres.
Dry mouth due to problems with the salivary glands is a common chronic condition, especially in the elderly (30% - 40% affected), individuals with rheumatic disorders such as Sjogren’s syndrome (100%), and after treatment for head and neck cancer (90%). Reduction in saliva production causes oral discomfort, impairs speech, eating, swallowing, and can lead to oral and dental infections and a notable reduction in quality of life. Treatment of dry mouth is challenging, as salivary gland damage is often irreversible. Research by Fedele and his team at UCL showed that existing treatments are either not effective or have significant side-effects1,2. There is an unmet need for an effective treatment for chronic dry mouth, an under-researched disorder.
Professor Fedele and an international multidisciplinary consortium of investigators with funding from the EC Framework Programme and industry (€1.5M, 2002) developed an electronic device which is placed in the mouth and stimulates the nerves (electro-neurostimulation) controlling salivary gland function. The research was informed by preliminary PPI work confirming that patients would prefer a non-drug treatment that could increase saliva production, have minimal undesired effects and be suitable for use by people of all ages. The new patented device was tested in a first-in-human proof-of-concept clinical trial, leading to EU and US permission to market it commercially3. Professor Fedele secured NIHR and Arthritis Research UK funding for further UCLH-led early clinical testing in particularly affected patients, including those with Sjogren’s syndrome and post-radiotherapy head and neck cancer survivors (£280K, 2011).
Professor Fedele has secured further funding from Versus Arthritis to run a trial (£440K, 2016) to provide definitive evidence of cost-effectiveness in patients with Sjogren’s syndrome. The ambition is to revolutionise the treatment of Sjogren’s, the second most common rheumatic disorder affecting 3% of the UK adult population (around 1.5M people).
1. Al Hamad A et al. Oral Dis, 2019; 2. Mercadante V et al. J Clin Oncol, 2021; 3. Strietzel FP et al. Oral Dis, 2007
