Bethesda, Maryland 20892


Purpose:

Background: - 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. Objectives: - To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives. Eligibility: - 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. Design: - 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


Study summary:

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.


Criteria:

- INCLUSION CRITERIA: - Persons older than 4 years of age, affected with or suspected of being affected with a disease/disorder involving the salivary glands, or who is a relative of a person who is affected with these diseases/disorders. Or -Persons 18 years or older with active hepatitis with or without siccasymptoms. Or - Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied. EXCLUSION CRITERIA: - Anyone not able to give consent/assent or parental/guardian consent - NIH employees who report directly to the principal investigator - Significant concurrent medical condition or other circumstances that may affect the participant s ability to tolerate or complete the study, such as concurrent chemotherapy or bleeding disorders. - Additional exclusion criteria for Healthy Volunteers (HV): 1. Pregnancy 2. Sicca Symptoms 3. HIV, hepatitis B or C infection 4. Chronic medical illness, other than well-controlled hypertension or hyperlipidemia 5. Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics


NCT ID:

NCT02327884


Primary Contact:

Principal Investigator
Blake M Warner, D.D.S.
National Institute of Dental and Craniofacial Research (NIDCR)

Eileen M Pelayo
Phone: (301) 594-3097
Email: pelayoem@mail.nih.gov


Backup Contact:

Email: blake.warner@nih.gov
Blake M Warner, D.D.S.
Phone: (301) 496-4486


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone: 800-411-1222
Email: prpl@cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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