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临床试验/CTRI/2022/07/044480
CTRI/2022/07/044480尚未招募不适用

Association between vitamin D levels and extensive dental caries in children

Manipal Academy of Higher Education Manipal1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
38
试验地点
1
主要终点
Primary outcome: To find out the association between Vitamin D levels and extensive dental caries in children

研究概览

简要总结

We propose to conduct a prospective observational  case-control study involving healthy children aged between 2 years to 16 years diagnosed to have extensive dental caries or dental problems other than caries, presenting to either the department of Paediatrics unit 1, Kasturba Hospital, Manipal or the department of Paedodontics, Manipal College of Dental Sciences, Manipal. Children with extensive dental caries will be considered as cases and children with no dental caries undergoing dental evaluation for any other cause would be taken as controls. Institutional ethics committee approval will be obtained prior to the commencement of the study. The study will be registered under CTRI. A written informed consent will be obtained from care givers of each child prior to the recruitement into the study. A detailed history of presenting illness including dental history will be recorded. A detailed diet history and exposure to sunlight will be recorded. Oral examination of each child will be done by the investigator from Paedodontics department. Caries status of the children will be recorded using decayed, extracted, missing and filled teeth (DMFT) index. A detailed systemic examination will be conducted by the investigator from Paediatrics department unit 1. History and physical examination findings will be recorded in control population similar to the cases. A venous blood approximately 2.5ml will be obtained from the study participants (cases and controls) and sent to the biochemistry laboratory for estimation of serum vitamin D levels. Serum Vitamin D levels less than 20 ng/ml will be considered as deficient. All the data will be compiled and subjected to statistical analysis using mean, paired t-test, and simple linear regression, and compilation of the result will be done. The serum vitamin D levels will be compared between cases and controls for statistical significance.

Faculty seed money grant of INR 35000 has been approved for the study from MAHE (Seed money ID: 00000521). The cost of vitamin D levels testing is INR 1140 per sample at Kasturba Hospital Laboratory. As per the research policy 20% discount has been approved for the test samples. Hence the cost of Vitamin D level test would be INR 912 for the study subjects. A total of 38 samples will be tested as per the budget.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • •Cases: Children aged between 2 years to 16 years and diagnosed with extensive dental caries requiring oral rehabilitation Controls: Healthy children aged between 2 years to 16 years presenting to Paedodontics department, MCODS for dental problems other than caries.

排除标准

  • •Exclusion criteria- Children < 2 years or > 16 years, children with chronic systemic illness such as rickets, renal disease, liver disease, malabsorption syndrome, chronic malnutrition or previously diagnosed to have vitamin D deficiency.

结局指标

主要结局

Primary outcome: To find out the association between Vitamin D levels and extensive dental caries in children

时间窗: Time bound study of one year

次要结局

  • To find out the severity of dental caries in children with vitamin D deficiency(time bound study of one year)

研究者

申办方类型
Private medical college

研究点 (1)

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