Characterization of Diseases With Salivary Gland Involvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02327884
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

December 30, 2014
December 31, 2014
August 24, 2018
December 30, 2014
January 1, 2025   (Final data collection date for primary outcome measure)
Hypothesis generating [ Time Frame: Ongoing ]
Same as current
Complete list of historical versions of study NCT02327884 on Archive Site
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Characterization of Diseases With Salivary Gland Involvement
Characterization of Diseases With Salivary Gland Involvement


- 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

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.

Observational Model: Cohort
Time Perspective: Prospective
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  • Healthy Volunteer
  • Sjorgren's Syndrome
  • Salivary Gland Disease
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 1, 2025
January 1, 2025   (Final data collection date for primary outcome measure)
  • 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.


-Persons 18 years or older with active hepatitis with or without siccasymptoms.


- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied.


  • Anyone not able to give consent/assent or parental/guardian consent
  • 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
Sexes Eligible for Study: All
4 Years and older   (Child, Adult, Older Adult)
Contact: Eileen M Pelayo (301) 594-3097
Contact: Blake M Warner, D.D.S. (301) 496-4486
United States
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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Blake M Warner, D.D.S. National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health Clinical Center (CC)
August 21, 2018