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Trial record 7 of 21 for:    Sjogren's Syndrome | NIH

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

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ClinicalTrials.gov Identifier: NCT03327870
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

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.


Condition or disease
Sjogren's Syndrome Oral Health

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1571 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 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
Estimated Study Start Date : June 26, 2018
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
1
Sjogren's Syndrome
2
Sicca
3
Incomplete Sjogren's Syndrome
4
Healthy Volunteers
5
Excluded by 2016 ACR/EULAR Classificastion Criteria



Primary Outcome Measures :
  1. Self-reported oral health needs and importance of key oral health indicators are the outcomes [ Time Frame: Survey completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria
  • INCLUSION CRITERIA:
  • Subjects enrolled in 94-D-0018, 11-D-0172, 15-D-0051 and previously enrolled in 84-D-0056 and 99-D-0070

EXCLUSION CRITIERIA:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03327870


Contacts
Contact: Lauren M Long, R.N. (301) 594-1644 longl@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center 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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Timothy J Iafolla, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)

Additional Information:
Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT03327870     History of Changes
Other Study ID Numbers: 180007
18-D-0007
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: May 9, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Sjogren's Syndrome
Sicca

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Dry Eye Syndromes
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases