Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 1
- 主要终点
- Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis
研究概览
简要总结
Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the development RA. The objective of this study is to examine the relationship of PD and P. gingivalis infection with the risk and severity of RA.
详细描述
In this study, we will examine whether periodontitis (PD) and P. gingivalis impact rheumatoid arthritis (RA) risk by enrolling 300 patients with RA and 300 comparator patients with osteoarthritis and comparing results from comprehensive dental examinations and antibody responses to P. gingivalis. We will examine whether these associations are modified by the presence of certain genetic risk factors previously implicated in RA and whether evidence of infection with P. gingivalis precedes RA onset by examining banked sera from the Department of Defense Serum Repository (DoDSR) and the Studies of the Etiology of RA (SERA). We also plan to explore whether there are novel proteins expressed by P. gingivalis that drive autoimmunity in RA and whether immune responses to these bacterial proteins predict the future development of RA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 years or older
- •Diagnosis of rheumatoid arthritis, or osteoarthritis
- •Have 9 or more evaluable posterior teeth (out of a total of 28 teeth, excluding third molars)
- •Willing and able to provide informed consent
排除标准
- •Received tetracyclines within the last 6 months.
- •Need for antibiotic premedication for dental probing.
- •Pregnant or breast feeding
结局指标
主要结局
Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis
时间窗: within thirty days of enrollment
Clinically defined PD will be more common in RA patients than in controls. 1.B.: Clinically defined PD will be associated with greater RA disease severity including autoantibody status and the presence and extent of radiographic disease progression. 1.C.: The associations of clinically defined PD with RA risk and severity will be explained by the presence of antibody to P. gingivalis.
次要结局
未报告次要终点