Potential Effects of Non-surgical Endodontic Treatment on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in Chronic Kidney Disease Patients With Apical Periodontitis- Interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Periapical Index(PAI)
研究概览
简要总结
The purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis.
详细描述
It has been found that there is an association between prevalence of odontogenic infection and systemic diseases. An elevated level of systemic cytokines has been observed in conjunction with both AP and CKD . The proinflammatory status and impaired immune response associated with systemic diseases (chronic kidney disease ) can affect the reparative response of the dental pulp and periapical healing. One study observed significant positive relation between number of diagnosed AP and urea serum level . A 4.35-mg/dL increase in the urea serum level could be expected per 1-unit increase in the number of teeth with AP. Improving oral health care through nonsurgical endodontic treatment(NSET) may improve the systemic inflammatory status and improve renal function.
The aim of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis
- Clinical and radiographic success rate will be considered as primary outcome, will be checked at baseline,6months,12months follow up.Periapical status will be checked according to periapical index given by Orstavik
- Reduction in inflammatory(hsCRP) and kidney makers(serum urea , creatinine , eGFR) will be considered as secondary outcome, will be checked at baseline,3months,6months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (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
- 是
入选标准
- •1- Known patient of Chronic Kidney Disease [CKD Stages 1,2,3,4,5 with mature permanent teeth.
- •Age18year or older .
- •≥ to 12 natural teeth (excluding 3rd molars) 4 The periapical index (PAI) was used to evaluate the periapical status patients with PAI ≥3 are included in the study.
排除标准
- •Patients having systemic disorders other than chronic kidney disease (e.g HIV; Diabetes mellitus; Coronary heart disease; no history of secondary hyperparathyroidism)
- •Patients with periodontitis , pocket depth and CAL>5mm( stage 3 ,4) will be excluded.
- •Pregnancy; lactation & contraceptives.
- •Patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.
结局指标
主要结局
Periapical Index(PAI)
时间窗: 12MONTHS
Periodical status will be assessed in periodical radiograph and scoring of periapical index will be done according to size and periphery of peri-apical radiolucency with coding 1 to 5
次要结局
- Blood urea(3-6MONTHS)
- eGFR(3-6MONTHS)
- hs-CRP(3-6MONTHS)
- serum creatinine(3-6MONTHS)