Systemic SclerosisNCT05215431
Periodontal Health Status in Patients with Systemic Sclerosis
A study testing periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis, Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) and Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid in people with Systemic Sclerosis and Periodontitis, run by University of Belgrade at 1 site in Serbia.
Trial summary
The aim of the research will be to evaluate the effects of NSPT on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (VEGF, TGF-β, IL-17) in the GCF in SSc patients in comparison with systemically healthy controls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Sclerosis, Periodontitis
- What is being tested?
- periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis, Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) and Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 5 Feb 2019to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- established diagnoses of systemic sclerosis and periodontitis (study group),
- age ≥ 18
- presence of minimum 12 teeth
Who cannot join
- concurrent inflammatory mediated rheumatic diseases
- pregnancy or lactation
- active cigarette smokers
- a history of periodontal, antibiotics or non-steroidal drug therapy in the past 6 months.
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Belgrade, 11000
Stefan Sredojevic, +381113317988, sredojevic43@gmail.com
About this study
Official title: The EFFECTS of NON-SURGICAL PERIODONTAL TREATMENT in PATIENTS with SYSTEMIC SCLEROSIS
The aim of the research will be to evaluate the effects of NSPT on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (VEGF, TGF-β, IL-17) in the GCF in SSc patients in comparison with systemically healthy controls. Twenty systemic sclerosis patients with periodontitis (SS group) and twenty systemically healthy periodontitis patients (P group) will be enrolled in the present study. The results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.
- Conditions
- Systemic Sclerosis, Periodontitis
- Being tested
- periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis, Activity of antioxidants in unstimulated saliva (GPX, SOD, UA), Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Periodontal treatment
- Keywords
- systemic sclerosis, periodontitis, antioxidants, saliva
- Medical subject headings
- Scleroderma, Systemic, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitisProcedure or surgery
Periodontal parameters has been recorded on six sites of each tooth using a manual periodontal probe. Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits. Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits . The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes.
Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)Diagnostic test
Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits.
Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluidDiagnostic test
Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits .
Periodontal treatmentProcedure or surgery
The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes.
| Study group | Role | What they receive |
|---|---|---|
| systemic sclerosis group | Experimental | Patients with established diagnoses of systemic sclerosis and periodontitis Receives: Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis; Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA); Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid; Procedure: Periodontal treatment |
| periodontitis group | Experimental | Systemically healthy periodontitis patients Receives: Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis; Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA); Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid; Procedure: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
Measuring the CAL by periodontal probe, measured in mm
Measured: one day
Probing depth (PD)
Measuring the PD by periodontal probe, measured in mm
Measured: one day
Gingival margin level (GML)
Measuring the GML by periodontal probe, measured in mm
Measured: one day
The degree of gingival inflammation
The degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.
Measured: one day
plaque index (PI)
Evaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).
Measured: one day
The concentration of vascular endothelial growth factor (VEGF)
The level of VEGF were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits.
Measured: baseline and two months after periodontal treatment
The concentration of transforming growth factor beta (TGF-β)
The level of TGF-β in gingival crevicular fluid was determined using commercial ELISA (enzyme-linked immunosorbent assay) kits at the Implant Research Center, School of Dental Medicine, University of Belgrade, following the manufacturer\'s instructions.
Measured: baseline and two months after periodontal treatment
The concentration of interleukin (IL)-17
interleukin (IL)-17 was determined using commercial ELISA (enzyme-linked immunosorbent assay) kits at the Implant Research Center, School of Dental Medicine, University of Belgrade, following the manufacturer\'s instructions.
Measured: baseline and two months after periodontal treatment
The concentration of glutathion peroxidase (GPX)
Activity level of GPX, determined using the colorimetric method and commercial kits.
Measured: one day
The concentration of uric acid (UA)
Activity level of UA, determined using the colorimetric method and commercial kits.
Measured: one day
The concentration of superoxide dismutase (SOD)
Activity level of SOD, determined using the colorimetric method and commercial kits.
Measured: one day
The concentration of tumor necrosis factor alpha
Measured: baseline and two months after periodontal treatment
The concentration of C reactive protein
Measured: baseline and two months after periodontal treatment
Erythrocyte sedimentation rate (ESR)
Measured: baseline and two months after periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start5 Feb 2019
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasa Nikolic Jakoba, University of Belgrade
- Investigators
- Natasa Nikolic Jakoba, DDS, PhD, Principal investigator, School of Dental Medicine, University of Belgrade, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215431
- Sponsor's protocol ID
- Unique Protocol ID: UBelgrade7
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EFFECTS of NON-SURGICAL PERIODONTAL TREATMENT in PATIENTS with SYSTEMIC SCLEROSIS
- ClinicalTrials.gov ID
- NCT05215431
- Acronym / sponsor ID
- Unique Protocol ID: UBelgrade7
- Conditions
- Systemic Sclerosis, Periodontitis
- Keywords
- systemic sclerosis, periodontitis, antioxidants, saliva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 31 Jan 2022 (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.
The aim of the research will be to evaluate the effects of NSPT on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (VEGF, TGF-β, IL-17) in the GCF in SSc patients in comparison with systemically healthy controls. Twenty systemic sclerosis patients with periodontitis (SS group) and twenty systemically healthy periodontitis patients (P group) will be enrolled in the present study. The results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic sclerosis group | Experimental | Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis, Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA), Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Procedure: Periodontal treatmentPatients with established diagnoses of systemic sclerosis and periodontitis |
| periodontitis group | Experimental | Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis, Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA), Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Procedure: Periodontal treatmentSystemically healthy periodontitis patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- established diagnoses of systemic sclerosis and periodontitis (study group),
- age ≥ 18
- presence of minimum 12 teeth
Key exclusion criteria (4 listed)
- concurrent inflammatory mediated rheumatic diseases
- pregnancy or lactation
- active cigarette smokers
- a history of periodontal, antibiotics or non-steroidal drug therapy in the past 6 months.
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 examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitisPeriodontal parameters has been recorded on six sites of each tooth using a manual periodontal probe. Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits. Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits . The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes. | Procedure or surgery | periodontitis group, systemic sclerosis group |
| Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits. | Diagnostic test | periodontitis group, systemic sclerosis group |
| Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluidTotal cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits . | Diagnostic test | periodontitis group, systemic sclerosis group |
| Periodontal treatmentThe therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes. | Procedure or surgery | periodontitis group, systemic sclerosis group |
Primary outcome
Clinical attachment level (CAL)
Time frame: one day
Measuring the CAL by periodontal probe, measured in mm
Probing depth (PD)
Time frame: one day
Measuring the PD by periodontal probe, measured in mm
Gingival margin level (GML)
Time frame: one day
Measuring the GML by periodontal probe, measured in mm
The degree of gingival inflammation
Time frame: one day
The degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.
plaque index (PI)
Time frame: one day
Evaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).
The concentration of vascular endothelial growth factor (VEGF)
Time frame: baseline and two months after periodontal treatment
The level of VEGF were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits.
The concentration of transforming growth factor beta (TGF-β)
Time frame: baseline and two months after periodontal treatment
The level of TGF-β in gingival crevicular fluid was determined using commercial ELISA (enzyme-linked immunosorbent assay) kits at the Implant Research Center, School of Dental Medicine, University of Belgrade, following the manufacturer\'s instructions.
The concentration of interleukin (IL)-17
Time frame: baseline and two months after periodontal treatment
interleukin (IL)-17 was determined using commercial ELISA (enzyme-linked immunosorbent assay) kits at the Implant Research Center, School of Dental Medicine, University of Belgrade, following the manufacturer\'s instructions.
The concentration of glutathion peroxidase (GPX)
Time frame: one day
Activity level of GPX, determined using the colorimetric method and commercial kits.
The concentration of uric acid (UA)
Time frame: one day
Activity level of UA, determined using the colorimetric method and commercial kits.
The concentration of superoxide dismutase (SOD)
Time frame: one day
Activity level of SOD, determined using the colorimetric method and commercial kits.
The concentration of tumor necrosis factor alpha
Time frame: baseline and two months after periodontal treatment
The concentration of C reactive protein
Time frame: baseline and two months after periodontal treatment
Erythrocyte sedimentation rate (ESR)
Time frame: baseline and two months after periodontal treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Natasa Nikolic Jakoba, DDS, PhD principal investigator
School of Dental Medicine, University of Belgrade, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis, Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) and Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid in people with Systemic Sclerosis and Periodontitis, run by University of Belgrade at 1 site in Serbia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasa Nikolic Jakoba, DDS, PhD (+381112685288, natasa.nikolic.jakoba@stomf.bg.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (CAL) (time frame: one day). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.