Characterizing clinical findings of Sjögren’s Disease patients in community practices using matched electronic dental-health record data

**Background:** Sjögren’s Disease (SD) is a chronic autoimmune disorder affecting over 4 million Americans, with an estimated 2.5 million undiagnosed. Delayed diagnosis is common due to nonspecific symptoms and lack of consensus on diagnostic criteria for clinical settings. SD patients experience significant dental disease burden, yet SD is rarely diagnosed in dental clinics. This study aimed to establish criteria to characterize and classify SD clinical presentations using electronic health record (EHR) data, determine associations with comorbidities, and assess documentation of SD in electronic dental records (EDR).

**Methods:** The study linked EDR data from Indiana University School of Dentistry (IUSD) with EHR data from the Indiana Health Information Exchange (IHIE), which connects 123 hospitals, 38 hospital systems, and over 54,505 providers. Of 195,503 dental patients with completed treatments between January 1, 2005, and December 31, 2020, 162,817 (83%) had EHR data. Querying for SD diagnostic codes (ICD9/10: 710.2; M35.0-M35.04, M35.09; internal code 8232) yielded 441 patients; after excluding 64 with conditions mimicking SD (e.g., head/neck radiation, hepatitis C, HIV/AIDS, sarcoidosis, lymphoma, amyloidosis, graft versus host disease, primary biliary cirrhosis, IgG4-related disease), 377 patients remained. Two calibrated reviewers manually examined EHR clinical notes, laboratory results, and diagnostic codes using nDepth™ (text mining/NLP tool) and REDCap. Classification criteria (Table 1) combined objective findings (histopathology: labial salivary gland biopsy ≥1 focus/4mm²; serology: anti-Ro/SSA ≥1 IU/ml, anti-La/SSB ≥1 IU/ml, ANA ≥1:160, RF ≥15; ocular staining test ≥3; salivary flow test <0.1 ml/min) and subjective symptoms (dry mouth, dry eyes, parotid gland enlargement). Patients were classified as positive (at least one positive objective finding plus symptoms), uncertain (abnormal autoantibodies except anti-Ro/SSA plus symptoms), or negative (normal/no objective findings or positive findings without symptoms). EDR clinical notes were also reviewed for SD documentation. Descriptive statistics and Chi-square tests were performed.

**Key Results:** The cohort (N=377) was 91% female, mean age 54.31±14.35 years, 84% aged >40 years. Classification yielded 90 (24%) positive, 74 (20%) uncertain, and 213 (56%) negative SD patients. Dry mouth and dry eyes were reported in 51% of the cohort; positive anti-Ro/SSA and ANA in 17%. Among positive SD patients, 89% had both dry mouth and dry eyes, and 77% had anti-Ro/SSA and ANA. Only 10% had positive salivary gland biopsy, 1% had positive ocular staining, and 1% had reduced salivary flow. In the uncertain group, 78% reported dry mouth and dry eyes, and 62% had positive RF. In the negative group, 40% had no symptoms or objective findings, and 26% had dry mouth and dry eyes without objective tests. Comorbidities: 98% had at least one medical comorbidity; 53% had other autoimmune conditions (rheumatoid arthritis 25%, systemic lupus erythematosus 20%, inflammatory arthropathy 12%). Significant differences across groups were found for chronic lymphocytic thyroiditis (p=0.027), psoriasis (p=0.015), Raynaud’s syndrome (p=0.012), rheumatism/fibrositis (p=0.034), rheumatoid arthritis (p=0.005), systemic connective tissue involvement (p=0.001), and systemic lupus erythematosus (p<0.001). Other common comorbidities: pain in joints (78%), hypertension (72%), esophageal reflux (63%), depressive disorder (60%), anemia (54%), osteoarthritis (42%). Pulmonary hypertension (p=0.034), osteoarthritis (p=0.047), and hypercholesterolemia (p=0.007) differed significantly. EDR documentation: 69% (259/377) had no mention of SD; among positive SD patients, 50% (45/90) had no SD documentation in EDR. Only 31% (118/377) had SD mentioned at any dental visit; 68% (258/377) had a dental visit after the SD index date.

**Clinical Implications:** The developed criteria can generate SD study cohorts from EHR data for longitudinal research, capturing heterogeneous clinical presentations seen in community practice. The high prevalence of comorbidities (especially autoimmune conditions) and the frequent absence of objective sicca testing (e.g., salivary flow, ocular staining) suggest that physicians often rely on serology and symptoms for diagnosis. The substantial gap in SD documentation in dental records (69% missing) underscores poor care coordination between medical and dental providers. Multidisciplinary care involving rheumatologists, dentists, and ophthalmologists is essential. Early screening for SD in patients with sicca symptoms, autoimmune conditions, or common comorbidities (e.g., pain in joints, hypertension, reflux) may improve diagnosis and prevent oral and ocular complications. Future studies should investigate disease progression, treatment outcomes, and the effectiveness of preventive caries management in SD patients.