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

NCT03711214 | Active Not Recruiting DMC

• 3 other identifiers: IPS - pSS2015/03756-42018/09937-9
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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

Study Arms (2)

pSS patients

ACTIVE COMPARATOR

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

Procedure: Periodontal scaling

Healthy individuals

ACTIVE COMPARATOR

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

Procedure: Periodontal scaling

Interventions

Periodontal scaling PROCEDURE

Periodontal scaling and root planing

Also known as: Clinical periodontal disease treatment

Healthy individuals; pSS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (3)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

Location

Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

Location

Related Publications (3)

• 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.

  PMID: 28099577 RESULT

• 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.

  PMID: 24370183 RESULT

• 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.

  PMID: 36189908 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical treatment of periodontal disease in pSS patients and healthy individuals

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: October 18, 2018
• Study Start: December 1, 2018
• Primary Completion: October 13, 2021
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)