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NCT00001852 · ClinicalTrials.gov registry record
Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome
A clinical trial, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- 560
- Enrollment target
NCT00001852: Completed study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00001852 is a clinical trial that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 560 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001852 has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- 560 participants
- Enrollment target
Study Summary
This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates food for easier swallowing, provides enzymes needed to begin the digestive process and promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or changes in salivary composition may affect oral and systemic health and cause an increase in tooth decay. Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary, secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study. Candidates will be screened with a complete medical and dental history and blood and saliva 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 Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory examination.) The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function. Participants will have a general oral examination of the teeth and soft tissues of the mouth, general physical examination, eye examination and blood tests and will fill out a questionnaire on oral health and function. In addition, they will have the following tests and procedures: * Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination. If a fungal infection is detected, treatment will be offered. * Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to col
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 1999-04-09 |
| Est. Completion | 2017-11-29 |
What the finished NCT00001852 record still lists
NCT00001852 is an observational study that tracks outcomes without assigning an intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00001852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001852 about?
NCT00001852 is a clinical study titled "Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome". This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates food for easier swallowing,...
What is the current status of trial NCT00001852?
This trial is currently completed. The enrollment target is 560 participants. The study started on 1999-04-09. Estimated completion is 2017-11-29.
Who is sponsoring clinical trial NCT00001852?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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