Oral Health Needs Assessment of Sjogren s Syndrome and Salivary Gland Dysfunction Cohorts and Healthy Volunteers Evaluating Oral Health Disparities as Determinants of Oral Health in a High-Risk Population

NCT03327870 | Completed

• 2 other identifiers: 18000718-D-0007
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

Background: A person s dental health depends on many factors. Some are social, economic, or behavioral. Some are environmental. People with Sj(SqrRoot)(Delta)gren s Syndrome have a change in the amount and quality of saliva. This may affect dental health. Researchers want to study the dental health needs of people with this and other salivary gland problems. They will compare these findings with healthy volunteers. This will help them improve health care for these groups of people. Objectives: To study dental health needs of people with salivary gland problems and healthy volunteers. To study the disparities in dental health between these groups. Eligibility: Adults 18 and older who were in a Sj(SqrRoot)(Delta)gren s Syndrome study Healthy volunteers the same age Design: Participants will take an online survey. It should take less than 30 minutes. They can skip any questions. They will be asked about dental health, general health, and well-being. Information in the survey will be kept secure.

Conditions

Sjogren's Syndrome; Oral Health

Keywords

Sjogren's Syndrome; Sicca

Outcome Measures

Primary Outcomes (1)

• Self-reported oral health needs and importance of key oral health indicators are the outcomes

  Survey completion

Study Arms (5)

1

Sjogren's Syndrome

2

Sicca

3

Incomplete Sjogren's Syndrome

4

Healthy Volunteers

5

Excluded by 2016 ACR/EULAR Classificastion Criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults classified as Sjogren's Syndrome (SS), Sicca, ISS, as well healthy volunteers as well as those excluded by the 2016 ACR/EULAR classification criteria for SS.

You may qualify if:

• Subjects enrolled in 94-D-0018, 11-D-0172, 15-D-0051 and previously enrolled in 84-D-0056 and 99-D-0070
• NIH employees working at NIDCR and under the supervision of SSGDU supervisors.
• Those less than 18 years of age.
• Those unable to give consent
• Those unable to speak English or Spanish.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Timothy J Iafolla, D.M.D.

  National Institute of Dental and Craniofacial Research (NIDCR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 1, 2017
• Study Start: May 1, 2018
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

US (1)