Clinical trial NCT03711214: Immune Profile of Saliva and Serum of Patients with Primary Sjögren´s Syndrome
Official title: Analysis of the Immune Profile of Saliva and Serum of Patients with Primary Sjögren´s Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sjogren's Syndrome
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical treatment of periodontal disease in pSS patients and healthy individuals
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Xerostomia Inventory Score at 3 months
timeFrame: Change from baseline Xerostomia Inventory Score at 3 months
measure: Change from baseline activity of DNAse I enzyme in saliva at 3 months
timeFrame: Change from baseline activity of DNAse I enzyme in saliva at 3 months
Secondary outcomes:
measure: Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months
timeFrame: Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
Study officials:
References:
citation: Ambrosio LM, Rovai ES, Franca BN, Balzarini DA, Abreu IS, Lopes SB, Nunes TB, Lourenco SV, Pasoto SG, Saraiva L, Holzhausen M. Effects of periodontal treatment on primary sjogren's syndrome symptoms. Braz Oral Res. 2017 Jan 16;31:e8. doi: 10.1590/1807-3107BOR-2017.vol31.0008.
citation: Nakamura-Kiyama M, Ono K, Masuda W, Hitomi S, Matsuo K, Usui M, Nakashima K, Yokota M, Inenaga K. Changes of salivary functions in experimental periodontitis model rats. Arch Oral Biol. 2014 Feb;59(2):125-32. doi: 10.1016/j.archoralbio.2013.11.001. Epub 2013 Nov 8.
citation: Martins VAO, Floriano TF, Leon EP, Villamarin LEB, Deveza GBH, Aikawa NE, Silva CAA, Kupa LVK, Peres MPSM, Braz-Silva PH, Bonfa E, Pasoto SG. Primary dental care treatment in primary Sjogren's syndrome: a possible role in improving salivary flow rate. Clin Exp Rheumatol. 2022 Dec;40(12):2258-2267. doi: 10.55563/clinexprheumatol/kfn28h. Epub 2022 Sep 26.