Efficacy of systemic administration of Omega 3 fatty acids when used as adjuvants to scaling and root planing on serum Nuclear Factor Kappa B levels in patients with Rheumatoid Arthritis and Periodontitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate if omega-3 fatty acids have beneficial effects in patients with rheumatoid arthritis and periodontitis when used as adjuvant to non surgical periodontal therapy
研究概览
简要总结
| • PERIODONTITIS: is a multifactorial chronic inflammatory infectious disease resulting in inflammation within the supporting tissues of the teeth, progressive attachment and bone loss characterized by pocket formation and/or recession of the gingiva. |
• RHEUMATOID ARTHRITIS: is a chronic systemic, auto immune, inflammatory disease affecting0.5 - 1% of world population. It is characterized by synovial hyperplasia, inflammatory cell recruitment and intra articular fibrin deposition that leads to destruction of joint architecture and consequent disability. Continuous low-grade infections, autoimmune and genetic traits are considered to be involved in the pathogenesis of RA
• PERIODONTITIS AND RHEUMATOID ARTHRITIS: The possible association between RA and periodontitis has been investigated because of numerous similarities in pathological and immunological characteristics. In spite of, the differences in etiologies of RA, and periodontitis, there are similar biological processes involved which may represent direct links between these two conditions.
• NONSURGICALPERIODONTAL THERAPY:
Scaling and rootplaning (SRP) is the cornerstone of periodontal therapy. It has been observed that the severity of RA in patients improved after SRP.
• OMEGA 3 FATTY ACIDS. Have well documented anti-inflammatory properties, and consequently therapeutic potential in chronic inflammatory diseases.
• NUCLEAR FACTOR KAPPA B : is a pro inflammatory marker which is elevated in chronic inflammatory conditions and shows association with microbial load and,cytokine release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Rheumatoid arthritis.
- •Patients with Chronic periodontitis.
- •For Periodontitis: 20 teeth should be present with probing pocket depths ≥ 5mm in one or more sites.
- •Rheumatoid arthritis patients with Anti-CCP levels Positive for antibodies – (>20u/ml).
排除标准
- •Pregnant and lactating women, Smokers, Patients with any auto immune or systemic disorder other than Rheumatoid arthritis.
- •Use of Medicines (other than RA medicines) or antibiotics 3 months before the commencement of the study.
- •History of periodontal treatment within 6 months.
结局指标
主要结局
To evaluate if omega-3 fatty acids have beneficial effects in patients with rheumatoid arthritis and periodontitis when used as adjuvant to non surgical periodontal therapy
时间窗: Baseline and 3 months
次要结局
- Plaque Index(PI),(Gingival Index (GI))