NCT00001852

Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome

Completed Last updated 17 December 2019

What this trial tests

trial in Lymphoma in 560 participants. Completed in 29 November 2017.

Timeline

9 April 1999

29 November 2017

Quick facts

Lead sponsor	National Institute of Dental and Craniofacial Research (NIDCR)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	560
Start date	9 April 1999
Estimated completion	29 November 2017
Sites	1 location across United States

Conditions studied

• Lymphoma — all drugs for Lymphoma →
• Salivary Gland Disease — all drugs for Salivary Gland Disease →
• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →
• Xerostomia — all drugs for Xerostomia →

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Who can join

4 and older, any sex, with Lymphoma or Salivary Gland Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates food for easier swallowing, provides enzymes needed to begin the digestive process and promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or changes in salivary composition may affect oral and systemic health and cause an increase in tooth decay.

Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary, secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study. Candidates will be screened with a complete medical and dental history and blood and saliva tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory examination.) The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.

Participants will have a general oral examination of the teeth and soft tissues of the mouth, general physical examination, eye examination and blood tests and will fill out a questionnaire on oral health and function. In addition, they will have the following tests and procedures:

* Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination. If a fungal infection is detected, treatment will be offered.
* Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to collection tubes over the salivary gland ducts in the mouth.
* Stimulated salivary function assessment A sour-tasting liquid (2% citric acid) is applied to the top and sides of the tongue at 30-second intervals to stimulation saliva production while saliva is collected using the procedure described above.
* Identification of markers of precancerous lesions The salivary gland biopsy done at the screening evaluation (or from outside sources) is examined for markers of precancerous lesions, as about 5 percent of patients with Sj(SqrRoot)(Delta)gren's syndrome develop a tumor called Non-Hodgkin s lymphoma. In some cases, the minor salivary glands may be re-biopsied a few years after the screening biopsy.

Patients will be followed once a year with a comprehensive history and physical examination, eye examination, full oral examination, salivary function assessment and questionnaires about signs and symptoms of salivary gland dysfunction.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. MicroRNA expression profiles as biomarkers of minor salivary gland inflammation and dysfunction in Sjögren's syndrome.
   Alevizos I, Alexander S, Turner RJ, Illei GG. · · 2011 · cited 130× · PMID 21280008 · DOI 10.1002/art.30131
2. IP3R deficit underlies loss of salivary fluid secretion in Sjögren's Syndrome.
   Teos LY, Zhang Y, Cotrim AP, Swaim W, et al · · 2015 · cited 57× · PMID 26365984 · DOI 10.1038/srep13953
3. Inhibition of bone morphogenetic protein 6 receptors ameliorates Sjögren's syndrome in mice.
   Yin H, Kalra L, Lai Z, Guimaro MC, et al · · 2020 · cited 19× · PMID 32076051 · DOI 10.1038/s41598-020-59443-z