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Periodontal Health Status in Patients with Systemic Sclerosis

The EFFECTS of NON-SURGICAL PERIODONTAL TREATMENT in PATIENTS with SYSTEMIC SCLEROSIS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05215431
Enrollment
60
Registered
2022-01-31
Start date
2019-02-05
Completion date
2024-11-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis, Systemic Sclerosis

Keywords

systemic sclerosis, periodontitis, antioxidants, saliva

Brief 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.

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.

Sponsors

University of Belgrade
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
plaque index (PI)one dayEvaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).
Clinical attachment level (CAL)one dayMeasuring the CAL by periodontal probe, measured in mm
Probing depth (PD)one dayMeasuring the PD by periodontal probe, measured in mm
Gingival margin level (GML)one dayMeasuring the GML by periodontal probe, measured in mm
The degree of gingival inflammationone dayThe degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.
The concentration of vascular endothelial growth factor (VEGF)baseline and two months after periodontal treatmentThe level of VEGF were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits.
The concentration of transforming growth factor beta (TGF-β)baseline and two months after periodontal treatmentThe 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)-17baseline and two months after periodontal treatmentinterleukin (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)one dayActivity level of GPX, determined using the colorimetric method and commercial kits.
The concentration of uric acid (UA)one dayActivity level of UA, determined using the colorimetric method and commercial kits.
The concentration of superoxide dismutase (SOD)one dayActivity level of SOD, determined using the colorimetric method and commercial kits.
The concentration of tumor necrosis factor alphabaseline and two months after periodontal treatment
The concentration of C reactive proteinbaseline and two months after periodontal treatment
Erythrocyte sedimentation rate (ESR)baseline and two months after periodontal treatment

Countries

Serbia

Contacts

Primary ContactNatasa Nikolic Jakoba, DDS, PhD
natasa.nikolic.jakoba@stomf.bg.ac.rs+381112685288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026