Controlling Early Childhood Caries and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To identify changes in caries incidence
研究概览
简要总结
This study will evaluate the effectiveness of oral health promotion in the prevention of ECC (early childhood caries) in bottle-fed children. Half of the patient will receive oral health promotion which emphasizing more on the benefit of stopping the bottle feeding habit, a free-flow cup and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride). The other half of the patient will receive standard of care oral hygiene promotion and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride)
详细描述
In Malaysia, even though there are decreasing trend in caries prevalence from a survey conduct in 1995 to 2015 (87.1% 1995, 76.2% 2005 and 71.3% 2015) [NOHPS 2015], yet the difference is just 15.8% in a period of 20 years. One of the factors which contribute to the development of ECC in children in prolonged bottle-feeding. Many literatures had mentioned association of bottle feeding and ECC however there are no controlled studies done on the effect of bottle feeding and ECC. Despite antenatal oral health promotion program done by Ministry of Health Malaysia and incorporation of oral hygiene education and oral hygiene instruction during dental visit, the prevalence of ECC remains high. This study will provide evidence regarding the effectiveness of oral health promotion in preventing early childhood caries by early termination of bottle feeding in toddlers.
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)
入排标准
- 年龄范围
- 1 Year 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian citizen
- •Child age 12 to 24 months old
- •Child with bottle feeding habit (patients from Klinik Kesihatan Ibu & Anak (KKIA))
- •Having at least 2 upper and 2 lower incisors at the time of recruitment
- •A child is taken care of predominantly by their mother (housewife) or a single carer (maid/ grandmother)
- •The parent who can read and write in Bahasa Melayu
- •Full Term baby
排除标准
- •Patient with medical problems
- •Cleft lip or cleft palate or both
- •Patient with a craniofacial anomaly
结局指标
主要结局
To identify changes in caries incidence
时间窗: Baseline, 6 month, 12 month
After the measurement of caries experience during the first visit, subject will be seen again in period of 6 month and 12 month to measure caries incidence on both group
次要结局
未报告次要终点