Evaluation of Serum Markers of Pro-diabetes Inflammation in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
研究概览
简要总结
Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes.
A case control study has been designed in order to evaluate serum levels of pro-diabetes inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or without apical periodontitis,before endodontic treatment and at 6 and 12 months post-treatment. The aim of the study is to evaluate any relation between the presence of chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset of insulin resistance, and whether endodontic treatment can reduce these factors, thus preventing a pro-diabetes status.
详细描述
Healthy, consenting and informed patients of both gender under 55 years of age with apical periodontitis will be enrolled as cases. Healthy, consenting and informed patients of both gender under 55 years of age without apical periodontitis will be enrolled as control subjects. The study has been designed to assess the serum level of TNF-α, IL-1β, IL-6, IL-8 by ELISA assay.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-55 years, healthy
排除标准
- •under 25 years, over 55 years, patients with systemic or oral diseases or patients who underwent other dental treatments in the previous 6 months
结局指标
主要结局
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
时间窗: Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
次要结局
未报告次要终点