Effect of the Community-based SIMS Programme on Preschool Children's Oral Hygiene Level: A Cluster Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 2
- 主要终点
- The mean decrement in plaque score assessed using the Oral Cleanliness Index
研究概览
简要总结
This is a cluster randomised control trial targeting 5-6-year-old children and their parents in Kampar district, Perak, Malaysia for a period of 6 months. In total, 28 preschools are randomly assigned into intervention and control group (14 preschools per group). Sample size for each group is 317 children. The intervention group receives the SIMS programme (SIMSP) which is an improved version of the usual care, while the control group receives the usual care. Usual care in defined as the existing preschool oral health programme (POHP) offered by the Ministry of Health. The SIMSP is formulated based on the recommendations from the National Oral Health Survey of Preschool Children's (2015) report. It comprises active participation of dental therapists (DT), parents and class teachers in children's oral health. The concept of the SIMSP is that improvement in oral health behaviours and oral hygiene of preschool children would result in improvement of gingival health and caries level in their permanent teeth in the long term. On the other hand, the control group involves DT visiting preschools twice a year without parental nor teachers active involvement. The scientific hypothesis of the study is that the SIMSP is more effective to improve oral hygiene level of preschool children than the POHP over 6 months. The primary objective of the study is to assess the effect of the SIMSP versus the POHP in improving oral hygiene level among 5-6-year-old children over 6 months. The secondary objectives are to assess the changes in oral health behaviours among the children and oral health literacy among parents over 6 months.
详细描述
Study Design:
This is a cluster randomised controlled trial. The overall duration of the study is 9 months and the duration of the intervention is 6 months. The reporting of this study is done in accordance with the SPIRIT 2013 guidance for protocols of clinical trials and the CONSORT checklist.
Study setting:
The study involves government-funded preschools that receive the POHP in Kampar district, Perak, Malaysia. Based on this criteria, 53 preschools in Kampar district are eligible to be included in the study.
Randomisation:
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)
入排标准
- 年龄范围
- 5 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who are healthy
- •Preschool children who can understand Malay language
- •Parents who can speak and write in Malay language
排除标准
- •Children with chronic medical conditions, dental/oral developmental conditions, long term medications, and physical disability
结局指标
主要结局
The mean decrement in plaque score assessed using the Oral Cleanliness Index
时间窗: 6 months
The mean decrement in plaque score from baseline to follow up between the intervention and control group will be assessed. Assessment for the presence of visible plaque will involve examining the labial surfaces of upper right to upper left primary canines. Each of the surface is assessed by scoring; 0 = teeth appear clean, 1 = a little plaque visible (existence of plaque around the labial cervical margins and covering \< ½ of labial tooth surfaces), 2 = substantial amount of plaque visible (plaque covering \> ½ labial tooth surfaces), and 9 = assessment cannot be made (there is no teeth in both anterior segments for plaque assessment). Total score is the sum of scores from the 6 surfaces. Mean decrement score is obtained by subtracting mean score at follow up from mean score at baseline. Finally, mean decrement scores of intervention and control group are compared.
次要结局
- Changes in child's oral health behaviours assessed using a self-reported questionnaire by parents(6 months)
- The mean increment of oral health literacy score of parents/guardians assessed using The Dental Health Literacy Assessment Index (DHLAI)(6 months)
