Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03711214

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Periodontal scaling

Procedure

Periodontal scaling and root planing

Other names: Clinical periodontal disease treatment

Primary outcomes

  1. Change from baseline Xerostomia Inventory Score at 3 months

    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.

  2. Change from baseline activity of DNAse I enzyme in saliva at 3 months

    Time frame: 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).

Secondary outcomes

  1. Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: pSS

Important dates

Study start
2018
Primary completion
2021
Study completion
2027
First posted
Oct 18, 2018
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.