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临床试验/NCT05706493
NCT05706493
已完成
不适用

Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients

Misr International University1 个研究点 分布在 1 个国家目标入组 36 人2024年3月1日

概览

阶段
不适用
干预措施
Non-surgical periodontal treatment
疾病 / 适应症
Periodontal Diseases
发起方
Misr International University
入组人数
36
试验地点
1
主要终点
Change in the level of anti-citrullinated protein antibodies (ACPAs)
状态
已完成
最后更新
3个月前

概览

简要总结

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients

详细描述

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 40 participants suffering from periodontitis and rheumatoid arthritis will be referred from the Badr Hospital (Faculty of Medicine, Helwan University) to Misr international university's dental clinic complex. Gingival crevicular fluid (GCF) samples will be collected from the patients before performing periodontal therapy (baseline). Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome at baseline and after 3 months. Assessment of 2ry outcomes includes clinical periodontal and RA parameters at baseline and after 3 months.

注册库
clinicaltrials.gov
开始日期
2024年3月1日
结束日期
2025年2月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Rheumatoid patients fulfilling the ACR criteria for the classification of RA
  • Both genders
  • Presence of at least 8 teeth

排除标准

  • Diabetes Mellitus
  • Pregnant females
  • Patients who had undergone periodontal treatment within last 3 months
  • Antibiotic therapy during last 3 months
  • Other autoimmune diseases

研究组 & 干预措施

Non-surgical periodontal treatment

assessment of different periodontal parameters and gingival crevicular fluid sampling will be done then non surgical periodontal treatment will be performed then after 3 months re assessment of the periodontal parameters and gingival crevicular fluid sampling will be done

结局指标

主要结局

Change in the level of anti-citrullinated protein antibodies (ACPAs)

时间窗: at baseline and 3 months

assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid

次要结局

  • Change in Plaque index (PI)(at baseline and 3 months)
  • Change in Probing depth(at baseline and 3 months)
  • Change in Clinical attachment Loss(at baseline and 3 months)

研究点 (1)

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