Toothbrushing Program in Saudi Arabia "TOPS"- A Cluster Randomized Controlled Trial in Kindergartens, Riyadh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 1
- 主要终点
- Prevalence of Dental caries using dmft score dental inspection
研究概览
简要总结
Project summary
Introduction: Dental caries is a major oral health problem worldwide and is a particular public health challenge in Saudi Arabia. Dental caries cause pain, infection, and negatively impact quality of life. As part of population oral health improvement efforts in Saudi Arabia, this project aims to evaluate the effectiveness of a supervised toothbrushing programme in kindergartens.
Aim: The aim of this project is to conduct a trial to assess the effectiveness of a supervised toothbrushing programme in kindergartens in Riyadh, Saudi Arabia .
Methods: A cluster randomized controlled trial study will be undertaken in which the effectiveness of the daily supervised toothbrushing programme intervention running for two academic years will be randomly allocated to a sample of kindergartens in Riyadh and compared against treatment as usual which will be an annual oral health awareness visit in the control group of kindergartens over and above community water fluoridation. Effectiveness will be measured and delivered in terms of preventing dental caries in children when compared with children in the treatment as usual control group receiving the same level of community water fluoridation, but not the toothbrushing program intervention.
All children in all kindergartens (both intervention and control groups) will have a dental examination (via trained and calibrated dental teams recording dental caries levels via dmft index) at baseline before intervention commences and at two academic years. In addition, questionnaires on behaviours and quality of life. In addition, process monitoring, and cost analysis surveys will be distributed.
Research Questions:
- Can such a supervised toothbrushing programme in kindergartens be effective at reducing the development of dental caries by 6 years of age?
- Can a supervised toothbrushing programme in kindergartens in Saudi Arabia be established and implemented?
详细描述
Background Studies confirmed caries and socio-economic factors association. Caries prevalence in children was related to parental factors, such as parents' socio-economic status, behaviors, and their attitudes to oral health. Several studies examined the prevalence of dental caries and associated social risk factors among preschool children in Riyadh, Saudi Arabia. Al-Meedani and Al-Dlaigan in 2016, found that among the total of 388 children examined in Riyadh, 69% had dental caries. There was no statistically significant difference between boys and girls in caries prevalence. There was a significant association between caries prevalence and parental educational level. Children of mothers with postgraduate degrees had higher caries prevalence of 57% while children of mothers with bachelor's degrees and high school level or below had caries prevalence of 66% and 78% respectively. The children of non-working parents had higher caries prevalence compared to those with working parents. The children from larger family size had higher caries prevalence as compared to those from smaller family size.
Another study by Wyne (2008) reported an overall caries prevalence of 74.8% among preschool children who had a mean age of 4.7 years in Riyadh. Similarly, Al-Malik et al (2003) found that 73% of two- to five-year-old children in Saudi Arabia were diagnosed with caries4. Another cross-sectional study by AlMarshad et al 2021, included Saudi preschoolers aged 36-71 months where a total of 383 children were examined. Early childhood caries (ECC) prevalence was 72.6%. Children from schools in northern Riyadh and those of fathers in professional jobs were less likely to have ECC. Children with a nocturnal feeding history and poor oral hygiene were more likely to have ECC.
Oral health improvement programms in education settings such as kindergartens and schools are particularly important because they have shown to be effective and can have the potential of a wide reach across the population during the crucial early years of childhood. Some studies have found that a programme of supervised daily toothbrushing in school can be effective in caries reduction particularly in high-risk populations, it can reduce caries increment in a population experiencing high levels of dental disease. In addition, school-based supervised toothbrushing programme can improve oral hygiene including decreasing levels of plaque, gingival bleeding, and gingivitis. There have been fewer randomized controlled trials of supervised toothbrushing programme particularly in areas with high caries or where other oral health improvement program or initiatives are in place such as water fluoridation.
In a trial including 2228 two to four year-old children attending kindergartens in two counties in northern Hesse, German were randomly allocated to participate in daily tooth brushing with 500 ppm fluoride toothpaste, which was supervised by specially trained dental nurses. The caries increment of the test group was 24% lower than the increment of the control group, and high increment values were observed in the control group twice as often as in the test group. Another trial in England recruited a total of 517 children (mean age 5.63 years) which children in the intervention group brushed once a day at school. For children in the intervention group, the overall caries increment (2.60) was significantly less than for children in the non-intervention group (2.92). In Kaunas city of Lithuania a sample of 411 three years old children were selected to participate in the prevention programme. For test group, supervised toothbrushing was prescribed, and for the control group, children did not undergo any of the procedures. The prevalence of dental caries varied between 39.7% and 90.8%, the reduction in test group was 45.4%. In another clinical trial in Tayside, that was to determine the reduction in two-year caries increment that can be achieved by daily supervised toothbrushing on schooldays, combined with recommended daily home use, compared to a control group involving no intervention. A sample of 534 children, mean age 5.3, in schools in deprived areas were recruited and significant reductions of 32% at D (1) and 56% at D (3) were found. In a study in Jordan, has a similar cultural and community background to Saudi Arabia, caries status of children in the supervised daily tooth brushing group over four years was better than that of the control group. The difference was statistically significant with estimates of relative risk values also showed that children in the control group are 3.1 and 6.4 times at higher risk of having dental caries than those in the study group for age group 12 and six respectively .
Although, there were no enough studies undertaken in background of water fluoridation or in the Saudi population, many international good studies for long follow-up periods had recommended to apply the supervised toothbrushing programme especially in communities with a high prevalence of caries, such as the Saudi community.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 42 Months 至 66 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receipt of a signed informed consent form from a parent or legal guardian.
- •Children in the second year of kindergarten school (known as KG2).
- •Children with or without pre-existing dental caries.
排除标准
- •Child is unwell on the same day of dental inspection.
结局指标
主要结局
Prevalence of Dental caries using dmft score dental inspection
时间窗: 2 years
worsening of decay will be tabulated and analysed by odds-ratios, with the attendant 95% confidence interval and p-value.
次要结局
- The numeric value of the number of excess teeth with obvious decay(2 years)
研究者
Budur Almutairi
Principal Investigator
University of Glasgow
