This trial is terminated!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Sjögren's Syndrome or Xerostomia
and you are
over 18
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
Show me locations

The purpose

Background: 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 actually works. Objectives: - To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome. Eligibility: - 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. Design: - 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 mouth symptoms. - 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.

Provided treatments

  • Drug: Dexamethasone Parotid Irrigation
  • Drug: Placebo Parotid Irrigation

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01316770. The sponsor of the trial is National Institute of Dental and Craniofacial Research (NIDCR) and it is looking for 14 volunteers for the current phase.
Official trial title:
A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects