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RecruitingNCT05215431Updated Sep 19, 2024

Periodontal Health Status in Patients with Systemic Sclerosis

An interventional study of periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis and Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) in Systemic Sclerosis and Periodontitis, sponsored by University of Belgrade. Recruiting at 1 site in Serbia. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Belgrade · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 11 months after the study started (first participant enrolled Feb 2019, registered Jan 2022).
  • Started Feb 2019; still recruiting 7 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Systemic Sclerosis
  • Periodontitis

Keywords

  • systemic sclerosis
  • periodontitis
  • antioxidants
  • saliva
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Belgrade is the lead sponsor of 70 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • established diagnoses of systemic sclerosis and periodontitis (study group),
  • age ≥ 18
  • presence of minimum 12 teeth

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    systemic sclerosis group

    Patients with established diagnoses of systemic sclerosis and periodontitis

    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

  • Experimental
    periodontitis group

    Systemically healthy periodontitis patients

    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

Interventions

  • Procedureperiodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis

    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.

  • Diagnostic testActivity 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 testTotal cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid

    Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits .

  • ProcedurePeriodontal treatment

    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.

06

What researchers measure

Primary outcomes

  1. Clinical attachment level (CAL)

    Measuring the CAL by periodontal probe, measured in mm

    Time frame: one day

  2. Probing depth (PD)

    Measuring the PD by periodontal probe, measured in mm

    Time frame: one day

  3. Gingival margin level (GML)

    Measuring the GML by periodontal probe, measured in mm

    Time frame: one day

  4. The degree of gingival inflammation

    The degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.

    Time frame: one day

  5. plaque index (PI)

    Evaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).

    Time frame: one day

  6. The concentration of vascular endothelial growth factor (VEGF)

    The level of VEGF were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits.

    Time frame: baseline and two months after periodontal treatment

  7. 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.

    Time frame: baseline and two months after periodontal treatment

  8. 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.

    Time frame: baseline and two months after periodontal treatment

  9. The concentration of glutathion peroxidase (GPX)

    Activity level of GPX, determined using the colorimetric method and commercial kits.

    Time frame: one day

  10. The concentration of uric acid (UA)

    Activity level of UA, determined using the colorimetric method and commercial kits.

    Time frame: one day

  11. The concentration of superoxide dismutase (SOD)

    Activity level of SOD, determined using the colorimetric method and commercial kits.

    Time frame: one day

  12. The concentration of tumor necrosis factor alpha

    Time frame: baseline and two months after periodontal treatment

  13. The concentration of C reactive protein

    Time frame: baseline and two months after periodontal treatment

  14. Erythrocyte sedimentation rate (ESR)

    Time frame: baseline and two months after periodontal treatment

07

Study locations

1 of 1 sites recruiting
  • Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
    Belgrade, 11000, Serbia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05215431
Lead sponsor
University of Belgrade
Responsible party
Natasa Nikolic Jakoba (Clinical Professor, University of Belgrade) — Principal investigator
First posted
Jan 31, 2022
Start date
Feb 5, 2019
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Sep 19, 2024

Study contacts

Natasa Nikolic Jakoba, DDS, PhD
Contact
natasa.nikolic.jakoba@stomf.bg.ac.rs
+381112685288
Natasa Nikolic Jakoba, DDS, PhD
principal investigator · School of Dental Medicine, University of Belgrade, Serbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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