Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Clinical attachment level
研究概览
简要总结
Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.
These new biotherapies could have an impact on periodontal status
- either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
- or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.
To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed.
- •At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status
- •Having expressed their written free and informed consent
排除标准
- •Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate
- •Severe or active infections
- •Systemic Pathology affecting the immune system including Sjögren's syndrome
- •Surgery in the previous month
- •HIV positive
- •Alcoholic
- •Toxicoman
- •Antibiotic treatment in the last 2 months
- •Legally protected patients
结局指标
主要结局
Clinical attachment level
时间窗: 6 month
Gain or loss obtained by periodontal probing.
次要结局
- Quantification of periodontopathogenic germs(6 month)
- Quantification of inflammation markers in the gingival fluid(6 month)
- Detection of periodontopathogenic germs(6 month)
- Assessment of inflammation(6 month)
- Assessment of oral hygiene level(6 month)
- Detection of inflammation markers in the gingival fluid(6 month)