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临床试验/NCT05215431
NCT05215431进行中(未招募)不适用

Antioxidant Profile in Unstimulated Saliva in Patients With Systemic Sclerosis and Periodontitis

University of Belgrade1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Clinical attachment level (CAL)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Clinical attachment level (CAL)

时间窗: one day

Measuring the CAL by periodontal probe, measured in mm

Probing depth (PD)

时间窗: one day

Measuring the PD by periodontal probe, measured in mm

Gingival margin level (GML)

时间窗: one day

Measuring the GML by periodontal probe, measured in mm

The degree of gingival inflammation

时间窗: one day

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

plaque index (PI)

时间窗: one day

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

The concentration of vascular endothelial growth factor (VEGF)

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: one day

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

The concentration of uric acid (UA)

时间窗: one day

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

The concentration of superoxide dismutase (SOD)

时间窗: one day

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

The concentration of tumor necrosis factor alpha

时间窗: baseline and two months after periodontal treatment

The concentration of C reactive protein

时间窗: baseline and two months after periodontal treatment

Erythrocyte sedimentation rate (ESR)

时间窗: baseline and two months after periodontal treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasa Nikolic Jakoba

Clinical Professor

University of Belgrade

研究点 (1)

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