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

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

- 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.