NCT00001196

Brief Summary

This study will evaluate patients 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 gland secretions have antibacterial, lubricatory, 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 oral mucosal; problems chewing, swallowing, and speaking; and diminished taste and smell. Patients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. In addition, patients with recent onset of arthritis may enroll. Patients with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the glands that produce saliva may be damaged. Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the jaw. Several blood samples will also be drawn for 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 Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1984

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 1984

Completed
15.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
15.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2015

Completed
Last Updated

July 2, 2017

Status Verified

September 29, 2015

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Sjogren's SyndromeSalivary Gland

Keywords

Salivary FunctionSalivary GlandSjogren's SyndromeDry Mouth

Outcome Measures

Primary Outcomes (1)

  • To determine the cause and severity of the subject's saivary gland dysfunction.

    1 Month

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have dry mouth symptoms (xerostomia) or a reasonable clinical suspicion of having Sj(SqrRoot)(Delta)gren s syndrome or other salivary gland disease
  • Ability to provide informed consent.

You may not qualify if:

  • a. Age less than 12 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

  • Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25. doi: 10.14219/jada.archive.1985.0384.

    PMID: 3858368BACKGROUND

  • Daniels TE, Fox PC. Salivary and oral components of Sjogren's syndrome. Rheum Dis Clin North Am. 1992 Aug;18(3):571-89.

    PMID: 1496162BACKGROUND

  • Fox PC, Speight PM. Current concepts of autoimmune exocrinopathy: immunologic mechanisms in the salivary pathology of Sjogren's syndrome. Crit Rev Oral Biol Med. 1996;7(2):144-58. doi: 10.1177/10454411960070020301.

    PMID: 8875029BACKGROUND

  • Tanaka T, Warner BM, Odani T, Ji Y, Mo YQ, Nakamura H, Jang SI, Yin H, Michael DG, Hirata N, Suizu F, Ishigaki S, Oliveira FR, Motta ACF, Ribeiro-Silva A, Rocha EM, Atsumi T, Noguchi M, Chiorini JA. LAMP3 induces apoptosis and autoantigen release in Sjogren's syndrome patients. Sci Rep. 2020 Sep 16;10(1):15169. doi: 10.1038/s41598-020-71669-5.

    PMID: 32939030DERIVED

  • Burbelo PD, Ferre EMN, Chaturvedi A, Chiorini JA, Alevizos I, Lionakis MS, Warner BM. Profiling Autoantibodies against Salivary Proteins in Sicca Conditions. J Dent Res. 2019 Jul;98(7):772-778. doi: 10.1177/0022034519850564. Epub 2019 May 16.

    PMID: 31095438DERIVED

  • Alevizos I, Alexander S, Turner RJ, Illei GG. MicroRNA expression profiles as biomarkers of minor salivary gland inflammation and dysfunction in Sjogren's syndrome. Arthritis Rheum. 2011 Feb;63(2):535-44. doi: 10.1002/art.30131.

    PMID: 21280008DERIVED

MeSH Terms

Conditions

Sjogren's SyndromeXerostomia

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ilias G Alevizos, D.M.D.

    National Institute of Dental and Craniofacial Research (NIDCR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 23, 1984

Study Completion

September 29, 2015

Last Updated

July 2, 2017

Record last verified: 2015-09-29

Locations

US(1)