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| ID | Type | Description | Link |
|---|---|---|---|
| 2015/03756-4 | Other Grant/Funding Number | FAPESP | |
| 2018/09937-9 | Other Grant/Funding Number | FAPESP |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Healthy individuals | Active Comparator | We will evaluate 40 healthy controls before and after periodontal disease treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal scaling | Procedure | Periodontal scaling and root planing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403-000 | Brazil | ||
| Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28099577 | Result | 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. | |
| 24370183 | 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. |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Clinical treatment of periodontal disease in pSS patients and healthy individuals
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Open Label
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| São Paulo |
| São Paulo |
| 05403-000 |
| Brazil |
| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | Brazil |
| 36189908 | Derived | 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. |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |