A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,020
- 试验地点
- 4
- 主要终点
- Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste
研究概览
简要总结
In this study we aim to study the effectiveness of a specially designed 21 day Brush Day and Night programme for school children aged 6-9 which aims to establish the habit of twice a day toothbrushing for oral health.
The 21 day programme is led primarily by teachers with support from a oral health care professional.
Schools will be recruited in Indonesia and Nigeria to take part in the study. Half of the schools will run the 21 day programme with their children in school grades 1 to 3, half will act as a control.
详细描述
Background The World Health Organization reports that dental cavities affect 60-90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programmes to improve brushing habits over their 12-year partnership. The last of these (Phase III) named Brush Day & Night aimed to educate children in brushing twice daily with a fluoride toothpaste and gave useful information for a new project, Phase IV. The 21-day Brush Day & Night programme is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The programme involves daily brushing instruction and includes free toothpaste and toothbrushes.
Objective In Phase IV of the partnership, the aim is to evaluate the impact on the knowledge, behaviour and toothbrushing habits in schoolchildren aged 6-9 years old, after a 21-day school programme and compare with baseline and a control group. The enduring nature of the programme will be determined by the inclusion of 8 and 24-week time points.
Methods The study is a two-arm superiority randomized controlled trial. Clusters in this study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20 schools, with children aged 6-9 years old, in each country.
At baseline, children in both intervention and control schools will answer a questionnaire and have their clinical oral health assessed using the Simplified Oral Hygiene Index (OHIs) and Decayed Missing and Filled Teeth (DMFT) index.
Children in the intervention schools will then take part in a structured 21-day Brush Day & Night intervention.
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 (Outcomes Assessor)
盲法说明
The data analysts / statisticians will not know whether the data they are analysing is from children in an Intervention or a Control school
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged in school year grades 1,2 and 3 years, aged 6-9 years
- •Be of either gender and in good general health
- •Be willing and be able (e.g. to brush teeth and understand and respond to questions) to participate in a 21-day Brush Day and Night activity at school and at home.
- •Planning on attending their currently registered school for at least the next seven months.
排除标准
- •Failure of the parent/carer/guardian to provide written informed consent.
- •Subjects scheduled for medical or dental procedures during the duration of the study.
- •Children who have a known allergy to any toothpaste ingredients
- •Obvious signs of gross or untreated caries or of significant periodontal disease which in the opinion of the Dentist would affect the scientific validity of the study, or if the subject were to participate in the study would affect their wellbeing.
- •Children or their family should have no affiliation (e.g. employee) with either the FDI or Unilever.
结局指标
主要结局
Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste
时间窗: Baseline, 21 days, 8 weeks, 24 weeks
Self-reported brushing frequency (no. of times a day) and time of day (morning / evening / other). Positive responses on use of a fluoridated toothpaste.
次要结局
- Change in visible plaque and debris on teeth(Baseline, 21 days, 8 weeks, 24 weeks)