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Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, Brazil
Start Date
December 1, 2018
Primary Completion Date
October 13, 2021
Completion Date
January 30, 2026
Last Updated
August 27, 2025
80
ESTIMATED participants
Periodontal scaling
PROCEDURE
Lead Sponsor
University of Sao Paulo General Hospital
NCT07413341
NCT04402086
Data Source & Attribution
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