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临床试验/NCT03158155
NCT03158155Unknown不适用

Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.

Nancy Ahmed El Salmawy0 个研究点目标入组 288 人开始时间: 2017年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
288
主要终点
Prevalence of early childhood caries

研究概览

简要总结

To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.

详细描述

Justification for undertaking the trial:

American Academy of Pediatric Dentistry (2012), defined early childhood caries (ECC) as the presence of one or more decayed, missing teeth (resulting from caries), or filled surfaces in the primary tooth of child 6 years old or younger.

Early childhood caries is a chronic childhood disease, that decreasing quality of life, this include pain, disturbed sleep, poor aesthetics, difficulty in eating and speaking and behavioral changes that affect the child's self-esteem. (Guay, 2004).

Due to the rising incidence of dental carries in early childhood, contributory factors need to be investigated in order to facilitate treatment of such a large population of children in desperate need of dental care (Guay, 2004).These multiple risk factors include the lack of a dental home, poor oral hygiene, diet, and nutrition ( Najeeb et al., 2016).

Enamel is the most mineralized substance in the human body; it is mainly made of calcium and phosphate. Vitamin D plays an important role in increasing the absorption of calcium and phosphate from food. Which calcium and phosphate improve the strength of the teeth as make them able to fight the demineralization from bacteria (Youssef et al., 2011). Therefore, it is responsible of promoting the calcification of teeth, having a topical fluoride like effect, and in the forming of enamel, dentin, and bone. (Mellanby & Pattison, 1928).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages from two to five years
  • Both sexes.
  • Parent and children cooperation.
  • Healthy children.
  • Children with serum vitamin D deficiency.

排除标准

  • Children age more than 5 years.
  • Children had a complex metabolic or medical disorder.
  • Parents that will not sign the consent.

结局指标

主要结局

Prevalence of early childhood caries

时间窗: 6 months

Stages of Early childhood caries. 1. Initial (reversible stage) 2. Damaged (carious) stage 3. Deep lesions 4. Traumatic stage. 5. Arrested caries.

次要结局

  • Gingivitis(6 months)
  • Delayed tooth formation and eruption(6 months)

研究者

发起方
Nancy Ahmed El Salmawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nancy Ahmed El Salmawy

Principal Investigator,

Cairo University

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