Characterization of Diseases With Salivary Gland Involvement

Healthy Volunteer Clinical Trial

Official title: Characterization of Diseases With Salivary Gland Involvement

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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 Sjogren 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. ;

Related Conditions & MeSH terms

• Healthy Volunteer
• Salivary Gland Disease
• Salivary Gland Diseases
• Sjogren's Syndrome

• NCT number: NCT02327884
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Eileen M Pelayo
• Phone: (301) 594-3097
• Email: eileen.pelayo@nih.gov
• Status: Recruiting
• Start date: April 3, 2015
• Completion date: April 1, 2032