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临床试验/NCT05217316
NCT05217316Unknown不适用

Assess the Impact of Virtual Supervised Tooth Brushing on Dental Caries and Quality of Life Among Primary School Children in Riyadh, KSA

King's College London2 个研究点 分布在 1 个国家目标入组 1,280 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,280
试验地点
2
主要终点
Dental Caries

研究概览

简要总结

Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. The combination of the large burden of untreated caries among school children, low uptake of dental services when asymptomatic and the availability of free dental services makes Saudi Arabia a unique setting for school-based dental programs. Despite the availability of free dental services provided through the Ministry of Health, universities' hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when in pain.

As schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.

详细描述

Background Dental caries is one of the most common diseases that afflict children in the Kingdom of Saudi Arabia and despite the availability of free dental services provided through the Ministry of Health, universities, hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when they are in pain thus, they reach the health care when they need complex care.

Aim The aim is to assess the impact of virtual supervised toothbrushing on dental caries and quality of life among primary school children in Riyadh, KSA.

Research Methodology This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). A 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months) by dental hygienist using World Health Organization criteria. Data on socio-demographic behavioral factors and children's quality of life will be collected at baseline and 12 months later through a structured questionnaire. The primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months. The secondary outcomes are the change in the frequency of brushing per day and the impact of oral health on the child's daily life (QoL).

Research Significance Schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.

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

20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. The schools who did not respond and refused to participate will be dropped and replaced randomly from the selected list. All data entry and management will be carried out by the study principal investigator. This will be applied by pseudo-anonymization, an artificial identifier (code) will be assigned to each subject as he enrolled in the study. All the study team members will deal with coded data while collecting or analyzing information.

入排标准

年龄范围
8 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 8 to 9 years (4th grade at school) at baseline
  • Both Saudis and non-Saudis
  • Children for whom the person with parental responsibility has signed the consent form

排除标准

  • Children in 5th and 6th grade (11- 12-year-olds) as they would have left schools by the time of the follow-up assessment (18 months later).
  • Children who refuse to participate in the study

结局指标

主要结局

Dental Caries

时间窗: 18 months

The study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.

次要结局

  • Frequency of Brushing(1 year)
  • Quality of Child's Daily Life(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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