Antioxidant Profile in Patients With Systemic Sclerosis and Periodontitis

Not Applicable

Active, not recruiting

• Conditions: Systemic Sclerosis; Periodontitis
• Interventions: 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

• Registration Number: NCT05215431
• Lead Sponsor: University of Belgrade

Brief Summary

The aim of the research will be to compare periodontal status and level of antioxidants in unstimulated saliva of systemic sclerosis patients with periodontitis and systemically healthy periodontitis patients.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
systemic sclerosis group	Periodontal treatment	Patients with established diagnoses of systemic sclerosis and periodontitis
systemic sclerosis group	periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis	Patients with established diagnoses of systemic sclerosis and periodontitis
systemic sclerosis group	Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)	Patients with established diagnoses of systemic sclerosis and periodontitis
systemic sclerosis group	Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid	Patients with established diagnoses of systemic sclerosis and periodontitis
periodontitis group	periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis	Systemically healthy periodontitis patients
periodontitis group	Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)	Systemically healthy periodontitis patients
periodontitis group	Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid	Systemically healthy periodontitis patients
periodontitis group	Periodontal treatment	Systemically healthy periodontitis patients

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	one day	Measuring the CAL by periodontal probe, measured in mm
Probing depth (PD)	one day	Measuring the PD by periodontal probe, measured in mm
Gingival margin level (GML)	one day	Measuring the GML by periodontal probe, measured in mm
The degree of gingival inflammation	one day	The degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.
plaque index (PI)	one day	Evaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).
The concentration of vascular endothelial growth factor (VEGF)	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)	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	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)	one day	Activity level of GPX, determined using the colorimetric method and commercial kits.
The concentration of uric acid (UA)	one day	Activity level of UA, determined using the colorimetric method and commercial kits.
The concentration of superoxide dismutase (SOD)	one day	Activity level of SOD, determined using the colorimetric method and commercial kits.
The concentration of tumor necrosis factor alpha	baseline and two months after periodontal treatment
The concentration of C reactive protein	baseline and two months after periodontal treatment
Erythrocyte sedimentation rate (ESR)	baseline and two months after periodontal treatment

Trial Locations

Locations (1)

Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia