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Trial record 18 of 67 for:    dry mouth | NIH

Evaluation of Salivary Gland Dysfunction

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ClinicalTrials.gov Identifier: NCT00001196
Recruitment Status : Terminated
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date July 2, 2017
Study Start Date March 23, 1984
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 30, 2015)
To determine the cause and severity of the subject's saivary gland dysfunction. [ Time Frame: 1 Month ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00001196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Sjogren's Syndrome
  • Salivary Gland
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 30, 2015)
1740
Original Enrollment
 (submitted: June 23, 2005)
9999
Study Completion Date September 29, 2015
Primary Completion Date Not Provided
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001196
Other Study ID Numbers 840056
84-D-0056
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
Study Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators Not Provided
Investigators
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 29, 2015