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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03711214
Acronym
pSS
Enrollment
80
Registered
2018-10-18
Start date
2018-12-01
Completion date
2027-01-30
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome

Brief summary

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.

Interventions

PROCEDUREPeriodontal scaling

Periodontal scaling and root planing

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Open Label

Intervention model description

Clinical treatment of periodontal disease in pSS patients and healthy individuals

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Xerostomia Inventory Score at 3 monthsChange from baseline Xerostomia Inventory Score at 3 monthsChange 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 activity of DNAse I enzyme in saliva at 3 monthsChange from baseline activity of DNAse I enzyme in saliva at 3 monthsChange from baseline activity of DNAse I enzyme in saliva at 3 months measured by Enzyme-Linked Immunosorbent Assay (ELISA).

Secondary

MeasureTime frameDescription
Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 monthsChange from baseline interleukin-1b (IL-1b) concentration in saliva at 3 monthsChange from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months measured by Luminex Assay.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026