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

Sjogren's Syndrome Clinical Trial

— pSS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03711214
• Other study ID #: IPS - pSS
• Secondary ID: 2015/03756-42018
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Procedure:
• Periodontal scaling
Periodontal scaling and root planing

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo
Brazil	Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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: 10.1590/1807-310 — View 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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline Xerostomia Inventory Score at 3 months
Primary	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).	Change from baseline activity of DNAse I enzyme in saliva at 3 months
Secondary	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.	Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months