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Evaluation of Salivary Gland Dysfunction

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Disease Information

Descriptive Information
Brief Title † Evaluation of Salivary Gland Dysfunction
Official Title † Evaluation of Salivary Gland Dysfunction
Brief 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.
Detailed Description This study will evaluate participants 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 secretions have antibacterial, lubricating, 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 or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell. Participants with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. 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 tongue. Several blood samples will also be drawn for tests. Some participants will have a biopsy of the minor salivary glands, usually from inside the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and to determine the extent of changes in the salivary glands. An eye examination including a standard eye examination and a dry eye assessment is done. The ability to taste and smell may also be evaluated, and participants may have an ultrasound examination of their swallowing function.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † To determine the cause and severity of the subject's saivary gland dysfunction.
Secondary Outcome Measure †
Condition † Sjogren's Syndrome Salivary Gland
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 1740
Start Date † March 23, 1984
Completion Date September 29, 2015
Primary Completion Date
Eligibility Criteria † - INCLUSION CRITERIA: 1. Subjects must have dry mouth symptoms (xerostomia) or a reasonable clinical suspicion of having Sj(SqrRoot)(Delta)gren s syndrome or other salivary gland disease 2. Ability to provide informed consent. EXCLUSION CRITERIA: a. Age less than 12 years.
Gender All
Ages 12 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00001196
Organization ID 840056
Secondary IDs †† 84-D-0056
Responsible Party Sponsor
Study Sponsor † National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators ††
Investigators † Principal Investigator: Ilias G Alevizos, D.M.D., National Institute of Dental and Craniofacial Research (NIDCR)
Information Provided By
Verification Date September 29, 2015
First Received Date † November 3, 1999
Last Updated Date April 21, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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