Characterization of Diseases With Salivary Gland Involvement
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|ClinicalTrials.gov Identifier: NCT02327884|
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : May 14, 2019
- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics.
- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives.
- People more than 4 years old who have or are suspected to have a disease involving salivary glands.
- Their relatives more than 4 years old.
- Healthy volunteers 18 years or older.
- Participants may be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- General oral and dental history and exam
- Saliva collection
- Eye exam and test for dry eyes
- Health questionnaires (adults)
- Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed.
- Participants will have 2 3 visits. These may include:
- Repeats of some screening tests
- Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand.
- Adults may have other biopsies
- A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct.
- Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup
- Scrapings collected from teeth, tongue, and cheeks
|Condition or disease|
|Healthy Volunteer Sjorgren's Syndrome Salivary Gland Disease|
This protocol is intended to allow disease-specific investigations in subjects with presentations of diseases with salivary gland involvement and will enable the collection of data, biological fluids and tissue samples from those subjects, their family members and normal controls, in order to assist our studies of understanding salivary gland disease pathophysiology. The exocrine salivary glands, by secreting saliva, play a critical role in the homeostasis of the oral cavity, which is the initial part of the gastrointestinal track. Several diseases including Parkinson s and systemic amyloidosis can be diagnosed through biopsies of easily accessible salivary glands. Moreover, several drugs and systemic diseases cause salivary gland hypofunction through unknown mechanisms.
We may 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.
This protocol will provide us with the opportunity to learn from a variety of pathologies that involve directly or indirectly the salivary glands, expand our knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Information obtained through this protocol may lead to potential innovative therapeutic studies. In addition to its role in investigating individuals who are of interest to the Sj(SqrRoot)(Delta)gren s syndrome (SS) and Salivary Gland Dysfunction Unit of the MPTB of NIDCR, this protocol can provide a possible avenue for enrolling subjects from other NIH programs or other NIH protocols that exhibit signs or symptoms associated with the salivary glands dysfunction.
|Study Type :||Observational|
|Estimated Enrollment :||1150 participants|
|Official Title:||Characterization of Diseases With Salivary Gland Involvement|
|Actual Study Start Date :||April 3, 2015|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||January 1, 2025|
- Hypothesis generating [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327884
|Contact: Eileen M Pelayo||(301) email@example.com|
|Contact: Blake M Warner, D.D.S.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Blake M Warner, D.D.S.||National Institute of Dental and Craniofacial Research (NIDCR)|