ESTIMATION OF THE EFFECT OF NONSURGICAL PERIODONTAL THERAPY ON HEPCIDIN, INFLAMMATORY AND IRON MARKER LEVELS AN INTERVENTIONAl STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- 1. serum hepcidin
研究概览
简要总结
Periodontitis is defined as an inflammatory disease of the supporting tissues of teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with periodontal pocket formation, gingival recession or both.
Gram negative bacteria such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetemcomitans play a significant role in the pathogenesis of chronic periodontitis. In conditions like chronic periodontitis associated with gram-negative bacteria porphyromonas gingivalis, Tannerella forsythia, Treponema denticola cause an imbalance towards pro inflammatory immune response and results in release of Interleukin1Beta, Interleukin 6 and Tumor necrosis factor Alpha.
Inflammatory cytokines such as Interleukin1Beta, Interleukin 6 and Tumor necrosis factor Alpha.
have seen to be increased in patients with chronic periodontitis and also in systemic diseases, it underlines a bidirectional link between chronic periodontitis and other chronic diseases.
Body iron load and inflammatory cytokines regulate the production of hepcidin, reflecting the association of this hormone with inflammatory disorders.
In a previous study, it was observed that successful Periodontal therapy results in a decrease in the serum levels of prohepcidin in patients with Chronic periodontitis with chronic kidney disease group or without chronic kidney disease control group
It has been postulated that periodontal therapy, both supragingival and subgingival scaling and root planning, may reduce serum Interleukin 6 and hepcidin levels, thereby reinforcing the positive effects of periodontal care on systemic health. Therefore, this interventional study is designed to evaluate the effect of non-surgical periodontal therapy on levels of serum hepcidin, inflammatory markers, and iron markers.
AIM
To estimate the effect of non-surgical periodontal therapy on levels of serum hepcidin, inflammatory markers, and iron markers among chronic periodontitis patients.
OBJECTIVES
1. To estimate Baseline values of serum hepcidin, pro inflammatory cytokines Interleukin, Interleukin 6 and Serum iron in healthy individuals with stage 2 and stage 3 periodontitis according to 2017 classification.
2. To evaluate and compare the effectiveness of scaling and root planning after a duration of 20 days follow up on serum hepcidin, pro inflammatory cytokines Interleukin 1, Interleukin 6 and Serum iron among stage 2 and stage 3 periodontitis according to 2017 classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •30-65 years of age.
- •Patients with only periodontitis and with no other systemic diseases.
- •Patients with no tooth loss; CAL 1 to 4 mm; PD less than or equal to 5 mm will be considered as Group 1, less than or equal to 5 teeth lost due to periodontitis, CAL greater than or equal to 5 mm, and PD greater than or equal to 6mm will be considered as Group 2.
排除标准
- •Pregnant and lactating women.
- •Systemically compromised patients.
- •No past history of smoking.
- •Patients under antibiotic drug therapy.
- •Patients under orthodontic treatment.
- •Patients with a history of steroid and nonsteroidal anti-inflammatory drugs.
- •Patients undergoing iron replacement therapy for anemia.
- •Patients who underwent subgingival scaling and periodontal surgery at least 6 months prior.
结局指标
主要结局
1. serum hepcidin
时间窗: 20 days
2. pro-inflammatory cytokines : IL-1Beta, hs-CRP, ESR
时间窗: 20 days
3. iron markers : Serum iron, transferrin saturation receptor, ferritin
时间窗: 20 days
次要结局
未报告次要终点
研究者
Putta Uday Simha
NITTE University