Evaluation of Salivary Gland Dysfunction

Sponsor
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00001196
Collaborator
(none)
1,740
1
378.2
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1740 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Salivary Gland Dysfunction
    Study Start Date :
    Mar 23, 1984
    Study Completion Date :
    Sep 29, 2015

    Outcome Measures

    Primary Outcome Measures

    1. To determine the cause and severity of the subject's saivary gland dysfunction. [1 Month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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:
    1. Age less than 12 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Dental and Craniofacial Research (NIDCR)

    Investigators

    • Principal Investigator: Ilias G Alevizos, D.M.D., National Institute of Dental and Craniofacial Research (NIDCR)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Dental and Craniofacial Research (NIDCR)
    ClinicalTrials.gov Identifier:
    NCT00001196
    Other Study ID Numbers:
    • 840056
    • 84-D-0056
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Jul 2, 2017
    Last Verified:
    Sep 29, 2015
    Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 2, 2017