Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body
tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able
to make enough saliva because their salivary glands are inflamed. The dry mouth that results
can interfere with daily activities and can lead to dental cavities, mouth sores, and
infections. Injections of corticosteroids into the parotid glands can improve saliva
production in people with Sjögren's syndrome, but current treatment practices may provide
only temporary relief. Researchers are interested in studying the effectiveness of stronger
corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment
- To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva
production in individuals with primary Sjögren's syndrome.
- Women between 18 and greater of age who have been diagnosed with primary Sjögren's
syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a
moderate level of inflammation.
- Participants will be screened with a full medical history and physical examination,
blood and urine tests, and salivary gland biopsies. Participants will also be screened
with tests of saliva flow production and evaluation of the salivary ducts and glands,
and will complete questionnaires about dry mouth symptoms.
- At the first treatment visit, participants will receive an injection of dexamethasone
into one parotid gland and an injection of saline into the other gland. After the
injections, participants will provide a blood sample to test the level of dexamethasone
in the blood.
- Two weeks after the first treatment, participants will return for an evaluation visit to
have saliva flow rate measurements taken, and will complete a questionnaire about dry
- Four weeks after the first treatment, participants will have a second treatment for each
parotid gland, with the same tests and questionnaires as before.
- Participants will have additional evaluation visits 6 and 8 weeks after the first
treatment visit, with a followup telephone call approximately 6 weeks after the last
dexamethasone treatment visit.