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临床试验/NCT04399512
NCT04399512Unknown不适用

Evaluation of Oral Health Status in Patients With Cirrhosis and Effect of Dental Treatment on MELD Score of Cirrhosis Patients

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
prevalence of apical periodontitis in patients with cirrhosis and healthy patients.

研究概览

简要总结

It has been found that there is an association between prevalence of odontogenic infection and systemic diseases.Cirrhosis has also been associated with poor oral health status.Treating those patients accordingly can help in reducing the source of infection to some extent and may be associated with reduction in mortality.

详细描述

Patients will be selected according to inclusion and exclusion criteria.Written informed consent will be taken from each participant after being informed about study .There will be two groups1) cirrhosis patients 2)normal healthy patients.Prevalence of apical periodontitis will be measured in both groups by intraoral examination,digital panoramic radiography.. MELD score will be recorded in cirrhosis patients at this stage.Non surgical root canal treatment will be performed in teeth with apical periodontitis. Periapical healing will be checked with the help of PAI Score given by Orstavik. In Cirrhosis patients MELD Score will be measured before and after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (cirrhosis patients)
  • Known patient of cirrhosis(Diagnosis of cirrhosis is based on blood testing, medical imaging, and liver biopsy.) with mature permanent teeth .
  • Age35-55 years
  • > or equal to 8 natural teeth(excluding 3rd molars);
  • I.N.R < 3.5

排除标准

  • (Cirrhosis patients)
  • Patient having systemic disorders other than hepatic disease(e.g. HIV, osteoporosis,diabetes,cardiovascular disease)
  • Use of systemic and topical antibiotic treatment within 3 months prior to the start of the study.
  • The eligibility criteria of the control group were the same for the cirrhosis group, except for the presence of liver disease. Cirrhosis patients were matched with controls according to sex, age (± 3 years old) and current smoking status and alcohol satus (yes/no).

结局指标

主要结局

prevalence of apical periodontitis in patients with cirrhosis and healthy patients.

时间窗: Baseline to 12 months

periapical index score will be assigned to intraoral periapical radiograph of teeth showing periapical radiolucency in orthopantomogram of each patient .PAI score 3,4,5 will be diagnosed with apical periodontitis . Score Description 1. Normal periapical structure 2. Small changes in bone structure 3. Changes in bone structure with some mineral loss 4. Periodontitis with well-defined radiolucent area 5. Severe periodontitis with exacerbating features

次要结局

  • Clinical and radiographic success(Baseline to 12 months)
  • association of prevalence of marginal and apical periodontitis with mortality measured by MELD score in cirrhosis patients(Baseline to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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