Extract

Background and study aims Reduced salivation (dry mouth) is a common complaint of individuals with Sjogren’s syndrome. It is a distressing condition which can lead to long-lasting oral discomfort, dental infections, diminished quality of life, social isolation and loneliness. As current treatments for dry mouth are often unsatisfactory, expensive and may result in adverse effects, further research in this area is needed. A new electronic device has recently been developed to treat dry mouth. The device, acting as a “salivary pacemaker”, is applied into the mouth (similar to a boxer’s mouthguard) for a few minutes, harmlessly stimulates the nerves of the salivary glands (salivary electrostimulation) and does not cause adverse side effects. The aim of this study is to assess the effectiveness of the device in patients with Sjogren’s syndrome to demonstrate whether using it daily is an effective treatment for dry mouth. The present study will pave the way for a future large study with a view to provide, for the first time, data regarding the long-term effectiveness of salivary electrostimulation. Who can participate? Individuals over 18 years of age who have been diagnosed with primary Sjogren's syndrome. What does the study involve? Participants will be randomly allocated to either receive the actual device or a sham device that will not deliver electric stimuli but only tactile stimulation (like using chewing gum). Participants will use the device for 6 months after receiving appropriate instructions, and will be allowed to continue using their routine local therapy for dry mouth (e.g. artificial saliva or sipping water) during the study. Participants will also be asked to attend hospital appointments to measure changes in saliva production and complete questionnaires on their dry mouth sensation. Each participant will keep a home diary of their frequency of use and any changes in dry mouth sensation. What are the possible benefits and risks for participants? Apart from helping medical research, study participants will benefit from using a new medication-free treatment that – based on previous research - is likely to lessen their dry mouth sensation. No significant risk is expected. Where is the study run from? University College London Hospital (lead centre) and Birmingham Dental Hospital. When is study starting and how long is it expected to run for? Recruitment started in March 2012 and is expected to close in March 2013. Who is funding the study? The study is sponsored by University College London Hospital Trust and funded by Arthritis Research UK. Who is the main contact? Stefano Fedele [email protected]

Inclusion criteria

• Oral, gastrointestinal and dental

Links

• isrctn
• ictrp