NCT03711214Active, not recruiting
Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 3 Sept 2018
- Start date
- 1 Dec 2018
- Primary completion date
- 13 Oct 2021
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Sjögren's disease
- NCT number
- NCT03711214
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Dec 2018 to the primary completion date, 13 Oct 2021
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of drugs that cause oral dryness (mainly antidepressants and antihistamines).
- History of periodontal treatment for at least 6 months prior to enrollment.
Other illness
- Patients with history of head and neck radiation therapy.
Other
- Current smoking.
- Pregnancy and/or lactation.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.