Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Changes in dental caries experience of the children from the age of 6 month to 18 months
研究概览
简要总结
The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of the mother-child initiated oral health care program, termed BASIS, in preventing early childhood caries (ECC).
The main questions it aims to answer are:
- To compare mean knowledge and attitudes scores in the prevention of ECC among mothers of toddlers in the study group before and after receiving the BASIS program.
- To compare mean knowledge and attitude scores in the prevention of ECC between mothers of toddlers in the study group after receiving the BASIS program and mothers of toddlers in the control group after receiving the current Ministry of Health (MOH) programs.
- To compare oral health care practices in the prevention of ECC between mothers in the study group after receiving the BASIS program and mothers in the control group after receiving the current MOH program.
- To compare caries incidence between toddlers in the study group and toddlers in the control group after mothers' exposure to the BASIS program and the current MOH program, respectively.
Researchers will compare the BASIS program to the MOH program to see if the BASIS is effective to prevent ECC.
Participants of the BASIS program:
- Received anticipatory guidance delivered during pregnancy and after given birth at 6 months and 12 months
- Complete self-administered questionnaires measuring the knowledge, attitudes and practices related to the prevention of ECC during pregnancy and after given birth at 6 months, 12 months and 18 months
- Have their child oral cavity clinically examined at 6 months, 12 months and 18 months
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First-time pregnant women
- •Aged 18 years and above
- •In their third trimester
- •Singleton pregnancy
- •Able to read and write in Malay language
- •Own a mobile phone with WhatsApp
- •Will be the primary caretaker of their newborn
排除标准
- •Diagnosed with cognitive disorders
研究组 & 干预措施
BASIS program
Prenatal and postnatal anticipatory guidance with home visits
干预措施: Anticipatory guidance and postnatal home visits (Behavioral)
Ministry of Health early childhood oral healthcare program
Postnatal anticipatory guidance
干预措施: Anticipatory guidance (Behavioral)
结局指标
主要结局
Changes in dental caries experience of the children from the age of 6 month to 18 months
时间窗: From the age of 6 month to 18 months
All surfaces of the four upper and lower front teeth of the children were examined at three time points: when the child reached 6 months old, 12 months old, and 18 months old. A sound tooth with no evidence of caries was coded as 0, while a tooth with evidence of caries, whether non-cavitated (such as white or brown spot lesions) or cavitated, was coded as 1.
次要结局
- Change in knowledge, attitudes, and practices of mothers regarding the prevention of ECC assessed by self-administered questionnaire from enrollment to the end of the intervention at 18 months postpartum(From enrollment to the end of the intervention at 18 months postpartum)
研究者
NORKHAFIZAH SADDKI
ASSOCIATE PROFESSOR DR.
Universiti Sains Malaysia