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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2026-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Clinical treatment of periodontal disease in pSS patients and healthy individuals

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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pSS patients

We will evaluate 40 patients with pSS (EULAR/ACR Classification Criteria, 2016) of both sexes before and after periodontal disease treatment.

Group Type ACTIVE_COMPARATOR

Periodontal scaling

Intervention Type PROCEDURE

Periodontal scaling and root planing

Healthy individuals

We will evaluate 40 healthy controls before and after periodontal disease treatment.

Group Type ACTIVE_COMPARATOR

Periodontal scaling

Intervention Type PROCEDURE

Periodontal scaling and root planing

Interventions

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Periodontal scaling

Periodontal scaling and root planing

Intervention Type PROCEDURE

Other Intervention Names

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Clinical periodontal disease treatment

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes