NCT03711214: pSS

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

Active, enrolled NA Last updated 27 August 2025

What this trial tests

NA trial testing Periodontal scaling in Sjogren's Syndrome in 80 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2018

Primary endpoint
13 October 2021

30 January 2026

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 December 2018
Primary completion	13 October 2021
Estimated completion	30 January 2026
Sites	3 locations across Brazil

Drugs / interventions tested

• Periodontal scaling

Conditions studied

• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →

Sponsor

University of Sao Paulo General Hospital

Who can join

18 and older, any sex, with Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Primary dental care treatment in primary Sjögren's syndrome: a possible role in improving salivary flow rate.
   Martins VAO, Floriano TF, Leon EP, Villamarín LEB, et al · · 2022 · cited 5× · PMID 36189908 · DOI 10.55563/clinexprheumatol/kfn28h