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临床试验/NCT03521492
NCT03521492已完成不适用

The Relationship Between Vitamin D Status and Early Childhood Caries Development: A Case-Control Piolet Study

Ministry of Health, Saudi Arabia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
vitamin D level of caries and caries free groups

研究概览

简要总结

Studies that give people vitamin D supplements to prevent caries have found that vitamin D is effective at preventing the development of caries.

The aim of Study:

To determine if there is a relationship between vitamin D deficiency and the development of Early Childhood Caries (ECC).

详细描述

Methodology:

This is a case-control pilot study to determine the relationship of vitamin D deficiency to the prevalence and severity of ECC. Patient selection and examination following inclusion and exclusion criteria, an Informed consent form will obtain from the parent or guardian after explaining the study in detail. Patients have a yearly pediatric medicine exam and blood drawn regardless of their participation in the study.

Inclusion Criteria:

  • Cases: Patients diagnosed with ECC who are treatment planned to receive full mouth dental rehabilitation under General Anesthesia (GA).
  • Age 71 months or younger.
  • Patients with an American Society of Anesthesiologists (ASA) Classification of 1 (Healthy person).
  • Controls: patients who present with no frank cavitated lesions upon visual and radiographic examination who are:
  • Patients of record at SFH for an annual exam with blood work patients will schedule to undergo an otolaryngology procedure under GA.

Exclusion Criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cases: Patients diagnosed with ECC who are treatment planned to receive full mouth dental rehabilitation under General Anesthesia (GA).
  • Age 71 months or younger.
  • Patients with an American Society of Anesthesiologists (ASA) Classification of 1 (Healthy person).
  • Controls: patients who present with no frank cavitated lesions upon visual and radiographic examination who are:
  • Patients of record at SFH for an annual exam with blood work patients will schedule to undergo an otolaryngology procedure under GA.

排除标准

  • Exclusion Criteria:
  • Patients with significant metabolic disorders and/or complex medical issues.
  • Patients with an ASA Classification of 2 or greater.
  • Patients received vitamin D supply
  • Controls: patients who present with frank cavitated lesions upon visual and radiographic examination.

研究组 & 干预措施

caries group

Experimental

干预措施: serum vitamin D , calcium , parathyroid hormone and albumin level (Diagnostic Test)

free caries group

Experimental

干预措施: serum vitamin D , calcium , parathyroid hormone and albumin level (Diagnostic Test)

结局指标

主要结局

vitamin D level of caries and caries free groups

时间窗: 7 months

次要结局

未报告次要终点

研究者

发起方
Ministry of Health, Saudi Arabia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ghazi S. AlAnazi

Pedodontist

Ministry of Health, Saudi Arabia

研究点 (1)

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