Protocol Number: 84-D-0056

Title:

Evaluation and Treatment of Salivary Gland Dysfunction

Number:

84-D-0056

Summary:

This study will evaluate patients with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary gland secretions have antibacterial, lubricatory, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning, or ulcerated oral mucosal; problems chewing, swallowing, and speaking; and diminished taste and smell.

Patients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. In addition, patients with recent onset of arthritis may enroll. Patients with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the glands that produce saliva may be damaged.

Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the jaw. Several blood samples will also be drawn for tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.

Sponsoring Institute:

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

a. Subjects must have dry mouth symptoms (xerostomia) or a reasonable clinical suspicion of having Sjogren's syndrome or other salivary gland disease

b. Ability to provide informed consent.

EXCLUSION CRITERIA:

a. Age less than 4 years.

Special Instructions:

Protocol is primarily seeking patients with Sjogren's syndrome, primary type.

Keywords:

Parotid Gland

Submandibular/Sublingual Glands

Xerostomia

Radiation Therapy

Sjogren's Syndrome

Recruitment Keyword(s):

Dry Mouth

Condition(s):

Sjogren's Syndrome

Xerostomia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Dental and Craniofacial Research

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Xerostomia: Evaluation of a symptom with increasing significance

The salivary and oral components of Sjogren's syndrome

Current concepts of autoimmune exocrinopathy: Immunologic mechanisms in the salivary pathology of Sjogren's syndrome

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/30/2009