Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease Activity Score 28 (DAS-28)
研究概览
简要总结
Periodontitis is an infectious disease defined by bacteria-mediated inflammation of the supporting tissues of the teeth that if left untreated may ultimately lead to the destruction of the attachment apparatus, culminating in tooth loss. Rheumatoid arthritis is a chronic destructive inflammatory disease characterized by autoantibodies and the accumulation and persistence of an inflammatory infiltrate in the synovial membrane that leads to synovitis and the destruction of the joint architecture. The objective of this study was to evaluate the possible beneficial additional value of non-surgical periodontal therapy on systemic markers of inflammation and clinical and serological parameters of rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects affected by rheumatoid arthritis with a stable therapeutic regimen for at least 3 months preceding the study participation
- •Subjects with at least 15 teeth
- •Subjects affected by severe generalized periodontitis that had undergone no periodontal treatment in the 6 months preceding the study participation
排除标准
- •Age younger than 18 years
- •Pregnancy or breastfeeding
- •Edentulism
- •Diagnosis of other autoimmune pathologies, liver disease, diabetes, early/juvenile arthritis or syndromes associated with RA
研究组 & 干预措施
Immediate periodontal treatment
Subjects assigned to this group were receiving non-surgical periodontal treatment as well as oral hygiene instructions immediately after their inclusion. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after the completion of the treatment. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after periodontal treatment.
干预措施: Immediate non-surgical periodontal treatment and oral hygiene instructions (Procedure)
Delayed periodontal treatment
Subjects assigned to this group were receiving non-surgical periodontal treatment 90 days after baseline evaluation. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after.
结局指标
主要结局
Disease Activity Score 28 (DAS-28)
时间窗: 90 days
Variation of DAS-28 90 days after periodontal treatment
次要结局
- C-Reactive Protein (CRP)(90 days)
- Interleuchin-6 concentration (IL-6)(90 days)
- Oral Health Related Quality of Life (OHRQoL)(90 days)
- Erythrocyte Sedimentation Rate (ESR)(90 days)
研究者
Filippo Graziani, DDS MClinDent PhD
FULL PROFESSOR
University of Pisa