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

NCT ID: NCT03327870

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-10-16

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.

Detailed Description

Objective:

Determinants of health, particularly oral health, have not been evaluated in the context of Sjogren s Syndrome (SS) and other salivary gland dysfunctions. It is known that the quantitative and qualitative changes in salivary flow that occur in SS place those with this complex autoimmune disorder at increased risk of dental caries, oral infections, mucosal ulceration, salivary gland enlargement and functional impairment. There is conflicting evidence on the risk of periodontal disease in this population. Furthermore, it has been reported that this population experiences a greater number of dental visits, decayed teeth, and dental restorations in the preceding year, and have a 2-3 fold increased annual out-of pocket dental care expenditure compared to those without SS. Moreover, the oral and dental needs of those with SS have not been quantified in the context of oral health disparities, i.e., by strata of vulnerable groups. Those with other salivary gland dysfunction such as Sicca and those who have signs and symptoms of salivary gland dysfunction that only partially fulfill the classification criteria for SS, also known as incomplete SS (ISS), have neither been assessed for oral health needs nor have oral health disparities been ascertained in this high-risk population.

Study Population:

We will enroll adults classified as SS, Sicca, ISS, as well healthy volunteers as well as those excluded by the 2016 ACR/EULAR classification criteria for SS. Therefore, the aims of this study are to:

1. Ascertain the oral health needs of those with SS, Sicca, and ISS in comparison with healthy volunteers (HV)

2. Identify oral health disparities in this high-risk population (SS, Sicca, ISS) in comparison with HV.

Design:

This will be an observational study with a cross-sectional survey administered to the study population at enrollment, to ascertain their oral health needs and oral health disparities.

Outcome Measures:

Study participants have been evaluated and classified into SS, Sicca, ISS, and HV cohorts as part of the SS clinical protocols: 84-D-0056, 99-D-0018, 11-D-0172, 15-D-0051 and 94-D-0018.

A. Primary outcome

Oral Health Outcomes will be captured using the protocols described in the NHANES Oral Health Questionnaire, with the inclusion of additional dental/oral health questions. All oral health outcomes will be ascertained once at the time of study enrollment. Self-reported oral health needs and self-reported importance of key oral health needs will be ascertained as part of the double-scaled oral health study instrument. This will enable discrepancy scoring of key oral health outcomes and calculation of a numeric needs index. These instruments have been pilot tested.

B. Exposures

Oral Health Disparities will be based on indicators for the following and will be ascertained at enrollment:

• Age
• Race
• Ethnicity
• SES levels (Educational attainment, employment status, home ownership, food security)
• Geographic location (Six-level urban-rural classification scheme for U.S. counties and county-equivalent entities developed by NCHS).
• Gender
• Sexual orientation
• Marital status
• Disabilities (physical disability)
• Mental health

Conditions

Sjogren's Syndrome; Oral Health

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Sjogren's Syndrome

No interventions assigned to this group

2

Sicca

No interventions assigned to this group

3

Incomplete Sjogren's Syndrome

No interventions assigned to this group

4

Healthy Volunteers

No interventions assigned to this group

5

Excluded by 2016 ACR/EULAR Classificastion Criteria

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy J Iafolla, D.M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Dental and Craniofacial Research (NIDCR)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

18-D-0007

Identifier Type: -

Identifier Source: secondary_id

180007

Identifier Type: -

Identifier Source: org_study_id