Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome

Study Overview
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Brief Summary
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Primary Sjögren's syndrome (pSS) is a chronic systemic inflammatory disease, which mainly affects the lacrimal and salivary glands, leading to sicca syndrome. pSS has a probable autoimmune etiology, with the production of several autoantibodies such as antinuclear antibodies (ANA), anti-Ro/SS-A, anti-La/SS-B, rheumatoid factor (RF) and cryoglobulins. Recently, our group described a high frequency of antibodies directed to DNase I in the serum of pSS patients and these antibodies were associated with the presence of the anti-Epstein-Barr (EBV) early antigen diffuse (anti-EA-D). This finding becomes interesting considering the recent description of reduction of DNase I activity in the tear of patients with xerophthalmia of different causes, which would result in an accumulation of extracellular DNA and neutrophilic inflammatory infiltrate on the ocular surface. This hypothesis is reinforced by the observation that treatment with DNase I as eye drops results in clinical improvement of dry eye. In addition, it has been shown that periodontal disease is an aggravating factor of xerostomia in pSS, as it leads to a chronic inflammatory process and, consequently, to the destruction of minor salivary glands. Therefore, the objective of the present study will be to evaluate the presence of antibodies directed to DNase I in the saliva and serum of pSS patients and its possible capacity of inhibition of the enzyme before and after treatment of periodontal disease. Such findings will be correlated with the presence of periodontal disease, with the glandular and extraglandular manifestations of SSp and also with the presence of EBV DNA in the serum and oral lavage of these patients.

Official Title
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Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Procedure: Periodontal scaling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary Sjögren's syndrome according to 2016 EULAR/ACR Classification Criteria, and healthy people without any rheumatic disease/symptoms of sicca syndrome Patients regularly followed at the Sjögren's Syndrome outpatient clinic of Rheumatology Division Exclusion Criteria: Use of drugs that cause oral dryness (mainly antidepressants and antihistamines). Patients with history of head and neck radiation therapy. Current smoking. Pregnancy and/or lactation. History of periodontal treatment for at least 6 months prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical treatment of periodontal disease in pSS patients and healthy individuals
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pSS patients<br>We will evaluate 40 patients with pSS (EULAR/ACR Classification Criteria, 2016) of both sexes before and after periodontal disease treatment. | Procedure: Periodontal scaling<br>* Periodontal scaling and root planing<br>* Other names: Clinical periodontal disease treatment;|
| Active Comparator: Healthy individuals<br>We will evaluate 40 healthy controls before and after periodontal disease treatment. | Procedure: Periodontal scaling<br>* Periodontal scaling and root planing<br>* Other names: Clinical periodontal disease treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Xerostomia Inventory Score at 3 months | Change from baseline Xerostomia Inventory Score at 3 months. An international validated questionnaire of dry mouth symptoms ranging from 11 to 55 points. | Change from baseline Xerostomia Inventory Score at 3 months | 
| Change from baseline activity of DNAse I enzyme in saliva at 3 months | Change from baseline activity of DNAse I enzyme in saliva at 3 months measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Change from baseline activity of DNAse I enzyme in saliva at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months | Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months measured by Luminex Assay. | Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months |