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

Primary Purpose

Sjogren's Syndrome

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Periodontal scaling
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sjogren's Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pSS patients

Healthy individuals

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 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).

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2018
Last Updated
November 7, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03711214
Brief Title
Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
Acronym
pSS
Official Title
Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical treatment of periodontal disease in pSS patients and healthy individuals
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pSS patients
Arm Type
Active Comparator
Arm Description
We will evaluate 40 patients with pSS (EULAR/ACR Classification Criteria, 2016) of both sexes before and after periodontal disease treatment.
Arm Title
Healthy individuals
Arm Type
Active Comparator
Arm Description
We will evaluate 40 healthy controls before and after periodontal disease treatment.
Intervention Type
Procedure
Intervention Name(s)
Periodontal scaling
Other Intervention Name(s)
Clinical periodontal disease treatment
Intervention Description
Periodontal scaling and root planing
Primary Outcome Measure Information:
Title
Change from baseline Xerostomia Inventory Score at 3 months
Description
Change from baseline Xerostomia Inventory Score at 3 months. An international validated questionnaire of dry mouth symptoms ranging from 11 to 55 points.
Time Frame
Change from baseline Xerostomia Inventory Score at 3 months
Title
Change from baseline activity of DNAse I enzyme in saliva at 3 months
Description
Change from baseline activity of DNAse I enzyme in saliva at 3 months measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Time Frame
Change from baseline activity of DNAse I enzyme in saliva at 3 months
Secondary Outcome Measure Information:
Title
Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months
Description
Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months measured by Luminex Assay.
Time Frame
Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28099577
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.
Results Reference
result
PubMed Identifier
24370183
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.
Results Reference
result
PubMed Identifier
36189908
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.
Results Reference
derived

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

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