Sjogren's SyndromepSSNCT03711214
Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
A study testing Periodontal scaling in people with Sjogren's Syndrome, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Periodontal scaling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 Dec 2018to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo
About this study
Official title: Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
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
- Being tested
- Periodontal scaling
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal scalingProcedure or surgery
Also called Clinical periodontal disease treatment
Periodontal scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Periodontal scaling |
| Healthy individuals | Active comparator | We will evaluate 40 healthy controls before and after periodontal disease treatment. Receives: Procedure: Periodontal scaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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 measured by Luminex Assay.
Measured: Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Dec 2018
- Primary completion13 Oct 2021
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Clinical treatment of periodontal disease in pSS patients and healthy individuals
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711214
- Sponsor's protocol ID
- IPS - pSS
- Other IDs
- 2015/03756-4, 2018/09937-9, 2018, 2015
- Acronym
- pSS
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2018
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28099577Nakamura-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.
PubMed 24370183Martins 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.
PubMed 36189908
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
- ClinicalTrials.gov ID
- NCT03711214
- Acronym / sponsor ID
- pSS / IPS - pSS
- Conditions
- Sjogren's Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical treatment of periodontal disease in pSS patients and healthy individuals
| Arm | Type | Receives |
|---|---|---|
| pSS patients | Active comparator | Procedure: Periodontal scalingWe will evaluate 40 patients with pSS (EULAR/ACR Classification Criteria, 2016) of both sexes before and after periodontal disease treatment. |
| Healthy individuals | Active comparator | Procedure: Periodontal scalingWe will evaluate 40 healthy controls before and after periodontal disease treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal scalingAlso: Clinical periodontal disease treatmentPeriodontal scaling and root planing | Procedure or surgery | Healthy individuals, pSS patients |
Primary outcome
Change from baseline Xerostomia Inventory Score at 3 months
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 activity of DNAse I enzyme in saliva at 3 months
Time frame: 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).
1 secondary outcome
Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months
Time frame: Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 28099577Ambrosio 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 publication: PubMed 24370183Nakamura-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.
- Derived from this study: PubMed 36189908Martins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal scaling in people with Sjogren's Syndrome, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Xerostomia Inventory Score at 3 months (time frame: Change from baseline Xerostomia Inventory Score at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03711214, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.