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临床试验/NCT05748054
NCT05748054已完成不适用

Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride

King Abdullah University Hospital1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Caries Prevention

研究概览

简要总结

In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Children (n=887) with mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159) who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only).

详细描述

Background: Early childhood caries is a well-known international public health challenge amongst young children.

Aims: To report the prevalence of early childhood caries in children attending kindergartens in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC.

Methods: This is a cross sectional epidemiological study comprised of children (n=887) with mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample received questionnaires to fill data related to their demographic, socioeconomic, oral hygiene, oral health, nursing and nutritional habits. These children were also examined to determine early childhood caries prevalence in Jordan. Among this sample there was a number of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample of a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only). Application of SDF started after distribution and receiving back approval letters from children's parents accompanied with questionnaires for data related to the approval/disapproval of the application. The sample were followed up for 1 year.

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
None

入排标准

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

入选标准

  • Children with early childhood caries involving anterior and/or posterior primary teeth
  • Children with with cavitated lesions with active caries
  • Children with no clinical signs of pulp involvement
  • Exclusion criteria:
  • Children with grossly broken down teeth
  • Children with teeth with more than one third of the crown missing
  • Children with pulpally involved teeth (with pulp exposure, presence of an abscess or a sinus) Children with obvious discoloration, and abnormal mobility

排除标准

  • 未提供

研究组 & 干预措施

Study group

Active Comparator

Children who receive a single application of 38% SDF

干预措施: Silver Diamine Fluoride (Drug)

结局指标

主要结局

Caries Prevention

时间窗: After 1 year of SDF application

Prevention of new cavities

Caries arrest

时间窗: After 1 year of SDF application

Arrest of existing cavities

Prevalence of early childhood caries

时间窗: After 1 year

The percentage of children with early childhood caries

次要结局

  • Risk factors for early childhood caries(After 1 year)
  • Parental acceptance of SDF(Before application of SDF)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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