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临床试验/NCT04898465
NCT04898465已完成不适用

Improving Family's Adherence to Dental Care After Dental General Anaesthesia (DGA). Helsinki Early Childhood Caries - Child Abuse and Neglect-study. (HECC-CAN)

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Number of uncancelled dental appointments after DGA

研究概览

简要总结

Early childhood caries (ECC) is a common disease. Its prevalence is highest in poor, socially disadvantaged, and minority groups. Dental treatment under General Anaesthesia (DGA) is common, especially among the youngest patients. Parental adherence to child's post-DGA dental treatment is varying. Non-attendance to preventive care appointments and dental check-ups after the DGA is also common. The primary aim of this study is to explore if a multi-professional (paediatrician and social worker) intervention after the child's DGA can increase the adherence to post-DGA dental care. The secondary aim is to compare its possible influence on children's oral health 18 months after the DGA. Our hypothesis is that multi-professional counselling and support after the DGA will lead to better adherence to the scheduled preventive dental programme and better oral health for these children in the long run.

详细描述

In an earlier Finnish study 26% of the children did not attend to their first scheduled appointment after the DGA and during a four years follow-up period 63% of the patients had one or more no-shows.

Based on the assumption that reducing the amount of no-shows to half of the reported earlier (60% vs. 30%) is a clinically relevant result, we need 42 patients for both groups (alpha 0.05, beta 0.2, power 0.8).

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • reason for DGA is dental caries
  • place of birth is Finland
  • primary dentition

排除标准

  • chronic disease which needs treatment in tertiary hospital

结局指标

主要结局

Number of uncancelled dental appointments after DGA

时间窗: 0-18 months after the DGA

Amount of unused or uncancelled dental appointment times after DGA

次要结局

  • Number of new decayed teeth after DGA(0-18 months after the DGA)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heikki Alapulli

Principal Investigator

Helsinki University Central Hospital

研究点 (1)

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