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临床试验/NCT06245265
NCT06245265已完成不适用

Evaluation of the Effect of Non-Surgical Periodontal Therapy on Serum and Salivary Biomarker Levels in Individuals With Rheumatoid Arthritis

Biruni University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis

研究概览

简要总结

Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Periodontitis has been associated with different host characteristics such as diabetes or neutrophil disorders and environmental factors such as smoking, alcohol consumption and stress. On the other hand, periodontal bacterial infection triggers a systemic immune response that is associated with an increased risk of different disorders such as bacterial pneumonia, cardiovascular disease and autoimmune diseases. Rheumatoid arthritis (RA) is a severe chronic autoimmune disease of unknown etiology, characterised by symmetrical, erosive synovitis of the joints, sometimes with multisystem organ involvement, joint destruction and excessive bone loss. Although the etiology of RA is unknown, it is thought to occur in individuals with genetic predisposition as a result of exposure to various environmental factors. RA and periodontitis are chronic destructive inflammatory diseases with common genetic and environmental risk factors, pathogenesis mechanisms and complex multifactorial pathological processes. Several studies suggest that periodontitis, a common inflammatory disease of the periodontium surrounding the teeth and triggered by bacteria in the mouth, is associated with RA and may initiate and worsen inflammation in RA. Non-surgical periodontal treatment (COPT), which is considered the gold standard in the treatment of periodontitis with hand instruments and ultrasonic instruments, has been shown to provide significant improvements in the clinical outcomes of periodontitis patients with RA. COPT is performed to stop the progression of periodontal diseases. Considering the studies supporting the bidirectional relationship between periodontitis and RA, it is thought that COPT may affect the clinical and biochemical values of RA. Based on these points, the aim of our study was to investigate the relationship between serum and salivary ANGPTL-4, MMP-13, TNF-α and IL-6 levels and periodontal disease in individuals with RA and to evaluate the effects of COPT on RA disease severity in vivo.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be between the ages of 18-65,
  • Having at least 8 teeth excluding wisdom teeth,
  • No periodontal treatment in the last 3 months,
  • Not having used antibiotics in the last 3 months,
  • Not being pregnant or breastfeeding,
  • The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except RA.

排除标准

  • Under 18 years of age and over 65 years of age,
  • Having less than 8 teeth,
  • Having undergone periodontal treatment in the last 3 months,
  • Having used antibiotics in the last 3 months,
  • Being pregnant or breastfeeding,
  • Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except RA.
  • Abnormal body mass index (more than 29.9 kg/m2).

结局指标

主要结局

Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis

时间窗: up to 1 year

Examination of ANGPTL-4 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with RA.

次要结局

  • Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.(up to 1 year)

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu KARADUMAN

Professor

Biruni University

研究点 (2)

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