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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 : April 12, 2021
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Brief Summary:


- 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

Detailed 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 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.

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Study Type : Observational
Estimated Enrollment : 1150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Characterization of Diseases With Salivary Gland Involvement
Actual Study Start Date : April 3, 2015
Estimated Primary Completion Date : April 1, 2032
Estimated Study Completion Date : April 1, 2032

Resource links provided by the National Library of Medicine

Group 1
Healthy Volunteers matched with Sjorgren's Syndrome patients
Group 2
Family Members, affected and unaffected
Group 3
any other cause salivary gland dysfunction

Primary Outcome Measures :
  1. Hypothesis generating [ Time Frame: Ongoing ]
    hypothesis generating

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with known or suspected Sjogren's syndrome and their family members (affected and unaffected) are potentially eligible participants. Subjects with other causes of salivary gland dysfunction (including hepatitis C) may also be potentially eligible for participation.
  • 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 sicca symptoms and patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer.

Specific to patients undergoing immunotherapy with an immune checkpoint inhibitor for threatment of oral cancer, these patients will be seen before and after check point inhibitor therapy which will coincide with 4 weeks (+/-2 weeks) before and again immediately before (+/- 2 weeks) definitive oral cancer treatment initiation (e.g., surgical resection, etc.).


- 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
  • 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.

    • Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an exclusion criteria.
    • Moreover, these immune checkpoint inhibitor subjects, if unable to tolerate the study procedures, such as salivary gland biopsies, saliva collections, and/or oral exams, will be excluded as determined by the Principal Investigator.
  • Additional exclusion criteria for Healthy Volunteers (HV):

    • Pregnancy
    • Sicca Symptoms
    • HIV, hepatitis B or C infection
    • Chronic medical illness, other than well-controlled hypertension or hyperlipidemia
    • Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics

Information from the National Library of Medicine

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 identifier (NCT number): NCT02327884

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Contact: Eileen M Pelayo (301) 594-3097
Contact: Blake M Warner, D.D.S. (301) 500-8063

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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   
Sponsors and Collaborators
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)
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR) Identifier: NCT02327884    
Other Study ID Numbers: 150051
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: February 6, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Dry Mouth
Sjogren's Syndrome
Gland Dysfuntion
Induced Pluripotent Stem Cell (iPS) Cell Lines
Additional relevant MeSH terms:
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Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases