Suspended

Evaluation of Salivary Gland Dysfunction

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arthritis+14

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

Over 12 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 1984
See protocol details

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 23, 1984

Actual date on which the first participant was enrolled.

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.

NCT00001196
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1740 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesEye DiseasesImmune System DiseasesJoint DiseasesLacrimal Apparatus DiseasesStomatognathic DiseasesMouth DiseasesMusculoskeletal DiseasesRheumatic DiseasesSalivary Gland DiseasesDry Eye SyndromesSkin and Connective Tissue DiseasesSjogren's SyndromeXerostomia

Criteria

1 exclusion criteria prevent from participating
Age less than 12 years

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
SuspendedOne Study Center