The Effect of the Different Number of Topics in Educational Video on Oral Health Status of Preschool Children: Study Protocol for a Cluster Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Plaque score using Modified Dental Plaque (MPI)
研究概览
简要总结
Purpose: This cluster randomized controlled trials study aims to investigate whether different number of topics delivered through educational video affect the oral health status, knowledge, attitude and practice of preschool children.
Hypothesis: The hypothesis of this study is the number of topics covered in educational videos aimed at preschool children will have a direct impact on their oral health status.
The specific hypothesis is the educational videos covering wide range of oral health topics will lead to better oral health outcomes in preschool children compared to videos focusing on limited number of topics. The higher number of topics delivered in educational video, the better oral health status, knowledge, attitude, and practice.
The alternative hypothesis is the combination of three topics on effective toothbrushing technique, effects of sugary food, and dental caries is effective to led to the most improvement in oral health status, knowledge, attitudes, and practices compared to two or only one topic.
Objectives: The objectives of this study were divided into primary and secondary.
The primary objective of the study is to assess the effect of different number of topics in educational video versus placebo video on mean difference in plaque score and gingival score among preschool children at baseline and 4 weeks after intervention.
The secondary objective is to assess the effect of different number of topics in educational video versus placebo video on mean difference in knowledge, attitude and practice score among preschool children at baseline and 4 weeks after intervention.
Participants: The study will involve 124 preschool children aged five to six years old.
Methods: Researchers will randomize classes in the school into five clusters using closed enveloped technique. These five clusters will be randomly assigned either into interventional groups or control groups. There are four intervention groups and one control group. Each intervention group will be compared to a control group for mean difference in plaque, gingival and KAP score at baseline and after intervention.
Duration: The study is expected to last 6 months (from subjects recruitment to final research report) with regular updates on progress.
Location: The study will be conducted at a preschool in Kota Bharu Kelantan.
详细描述
Study Design:
This is the phase I interventional cluster randomized controlled trial with multiple-arm parallel group assignment and single blinded masking for prevention of dental caries and gingivitis among preschool children.
The rationale of using this design because it is suitable for preschool-level and logistically simpler. Besides that, this design can minimize the risk of contamination and also resemble the real-word applicability of the program.
Study population:
Preschool children in Kota Bharu, Kelantan
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 (Participant)
盲法说明
Masking: Single-blinded, where participants are unaware of the type of intervention given to them (in which combination and either 1 topics, 2 topics or 3 topics)
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 aged five to six years old and understand the Malay language.
- •Children with normal cognitive and psychomotor ability equal to normal children aged five to six years old
- •Children who unable to read and write fluently but able to understand instructions
排除标准
- •Children with physical and psychological condition that prevents them from understanding and following the instruction.
结局指标
主要结局
Plaque score using Modified Dental Plaque (MPI)
时间窗: Baseline and 4 weeks after intervention
The index will be calculate dental plaque on each tooth surface. The MPI score is obtained by the sum of the plaque score for all teeth, divided by the number of surfaces scored. Minimum value for the score is 0, while the maximum value is 5. The higher the score value describes the more plaque accumulation on each subject. Therefore, a high plaque score is interpreted as poor oral hygiene status. To give clinical relevance to the index, the index translated into four oral hygiene categories as 0 - 1.25: Excellent, 1.25 - 2.50: Good, 2.50 - 3.75: Fair, 3.75 - 5.00: Poor
Gingival Score using Modified Gingivitis Plaque (MGI)
时间窗: Baseline and 4 weeks after intervention
The index will be calculated the extent and the severity of gingival inflammation using four ordinals. The MGI score is obtained by the sum of the gingival score for all teeth, divided by the number of surfaces scored. The minimum value for the score is 0, while the maximum value is 3. The higher the score value describes the more severe inflammation due to plaque accumulation in subject. Therefore, a high gingival score is interpreted as poor gingival health. To give clinical relevance to the index, the index translated into three gingivitis categories, 0 : No gingivitis, ≤1.0 : Mild gingivitis, ≤2.0 : Moderate gingivitis, ≤3.0 : Severe gingivitis.
次要结局
- Knowledge, Attitude, Practice (KAP) level using KAP score(Baseline and 4 weeks after intervention)
研究者
SITI NUR BAIDURI BINTI MOHD JAINI
Principle Investigator
Universiti Sains Malaysia