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临床试验/NCT05110534
NCT05110534已完成不适用

Randomized Controlled Trial on an Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia

University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
406
试验地点
2
主要终点
Caries and Initial Caries Index: decayed, missing, filled teeth (idmft)

研究概览

简要总结

Early childhood caries is a persistent problem often leading to dental treatment under general anaesthesia (GA). Thus, this study was to investigate the preventive effect of two additional intensive oral hygiene appointments before and after general anaesthesia.

In this randomized, controlled clinical trial, 408 children (age 2-5 years, mean 4.2+-1.04) intended for general anaesthesia were recruited and randomly assigned to the intervention and control groups with or without two additional intensive oral hygiene appointments before and after the general anaesthesia. At baseline and at 6-/12-month follow-ups, Approximal Plaque Index (API), gingiva Sulcus Bleeding Index (SBI), caries and initial caries index: initial, decayed, missing, filled, teeth (idmft) were recorded.

详细描述

Early Childhood Caries (ECC) is considered to be a global problem, as it is one of the most prevalent diseases in childhood. This leads to a severe problem in the caries risk children being highly affected by ECC, mostly also non-cooperative and from lower socio-economic background. The dental treatment for these pre-school children often requires general anaesthesia (GA), which is associated with health risks and considerable costs.

Thus, this study was to investigate the preventive effect of two additional intensive oral hygiene appointments before and after general anaesthesia.

After approval by the Ethics Committee at the University of Greifswald (No. BB 078/17), children with an age range from 2 to 5 years assigned for dental treatment under general anaesthesia were recruited.

After obtaining informed consent from the parents, the participants were randomly allocated to the test and control groups by a computer-generated random sequence prepared by a statistician, blinded to the recruiting person. Both groups received a baseline examination and the standard preventive program offered within the German National Health System consisting of explaining the etiology of caries and preventive approaches such as practical training of the parents in tooth brushing in their child as well as recommending fluoridated toothpaste and a reduction of cariogenic snacks. Finally fluoride varnish was applied. The test group received two additional preventive sessions including oral hygiene instructions using plaque disclosing agent, toothbrushing and fluoride application, one week before the date of the general anaesthesia treatment and at the control visit about a week after the general anaesthesia.

The baseline and follow-up examinations at 6 and 12 months recorded caries, fillings and missing teeth due to caries according to the World Health Organisation (WHO) criteria and it included initial caries lesions according to International Caries Detection and Assessment System (ICDAS 1-3). The subcomponents were also added up as initial, decayed, missing, filled, teeth/surfaces (idmft/idmfs). Due to the young age of the children, only primary teeth were of relevance.

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 (Investigator)

盲法说明

The participants were randomly allocated to the test and control groups by a computer-generated random sequence prepared by a statistician, blinded to the recruiting person.The examiners were blinded regarding the group status of the children, as other practice personal had to perform the preventive sessions.

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

  • 2-5 years old children attending dental treatment under general anaesthesia
  • parental approval

排除标准

  • children above 5 years old
  • no parental approval

结局指标

主要结局

Caries and Initial Caries Index: decayed, missing, filled teeth (idmft)

时间窗: 1 year

WHO index to assess caries prevalence and caries status

Approximal Plaque Index (API)

时间窗: 1 year

an index to assess oral health by calculating the accumulated dental plaque on teeth surfaces

Gingiva Sulcus Bleeding Index (SBI)

时间窗: 1 year

an index to assess oral health by calculating the inflammation and bleeding of the gingiva sulcus

次要结局

未报告次要终点

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (2)

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