Viewing Study NCT00001196



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001196
Status: TERMINATED
Last Update Posted: 2017-07-02
First Post: 1999-11-03

Brief Title: Evaluation of Salivary Gland Dysfunction
Sponsor: National Institute of Dental and Craniofacial Research NIDCR
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Evaluation of Salivary Gland Dysfunction
Status: TERMINATED
Status Verified Date: 2015-09-29
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Sjogrens 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 Sjogrens 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 SjSqrRootDeltagren 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
84-D-0056 None None None