Improved Oral Health in Children with Congenital Heart Disease - an Educational Intervention Trial to Maintain Good Oral Health and Dental Care in Children with Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Dental plaque
研究概览
简要总结
Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in children. As the risk for endocarditis following bacteraemia is more common during daily oral hygiene routines, such as tooth brushing, than during dental treatment, the maintenance of optimal oral health in children with CHD may be considered of outmost importance. Children with CHD have a higher caries prevalence compared to healthy controls.
Aim: The primary aim of the study is to explore if an educational intervention including information, counselling and support provided at early stage to families affected by major CHD, or CHD combined with a syndrome, can increase the awareness of the importance of maintaining of good oral health, and avoid the development of poor oral health including dental caries, leading to less dental anxiety and a higher oral heath related quality of life. The secondary aim is to elucidate factors associated with the development of poor oral health and/or orofacial dysfunction as well as family attitudes and needs of support.
Hypothesis: Early information, counselling and support will lead to a) increased awareness of the importance to maintaining good oral health, b) prevent the development of poor oral health and dental caries, c) lead to less dental fear, and d) lead to higher oral heath related quality of life.
Study design: Randomized educational intervention trial. Study population: Children born in Finland and under 12 months of age in 1.7.2017-31.12.2021 with, a) major CHD and potentially included in the criteria of endocarditis prophylaxis, or b) with a major CHD combined with a chromosomal syndrome, will be offered to participate in the study. Patients will be recruited until 200 patients are obtained at the Helsinki University Children's Hospital. A control group consisting of approximately 100 healthy children will also be recruited at birth.
Main outcomes: Dental caries, dental anxiety, oral health related quality of life, and awareness of importance to maintain and behaviour to maintain good oral health.
Significance: Better information to patients leads to better possibility to achieve good oral health. Better oral health leads to 1) less dental procedures and thereby less dental anxiety, 2) less dental procedures under general anaesthesia, which may potentially be a risk procedure for the child with CHD, and 3) better oral health related quality of life.
详细描述
Power analysis:
Children with CHD are at high risk of developing caries (Stecksén-Blicks C et al 2004). In Swedish high-risk areas for developing caries, 12 % of three-year-old children had moderate and severe carious lesions (ICDAS II 3-6) and 11% initial carious lesions (ICDAS II 1-2) (Anderson et al 2016). Based on the assumption that 10% in the intervention group and 30% in the control group will develop caries (ICDAS II 1-6), p<0.05 and power 0.80, a sample size of at least 65 individuals in each age group is required. 1.7.2017-31.12.2021 198 Finnish speaking families will be offered to participate in the study. To secure an even distribution block randomization will be used. The patients will be randomized into blocks of 4 and 8, with the help of www.randomization.com (Pandis et al 2011).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Dental plaque
时间窗: 36 months of age
During a clinical dental examination, visible plaque will be registered on the labial surfaces of the maxillary incisors (y/n) as a risk indicator for developing caries (Alaluusua and Malmivirta 1994).
Caries
时间窗: 36 months of age
During a clinical dental examination, caries will be registered clinically according to the ICDAS II (Pitts et al 2013, Shoaib et al 2009). The caries lesions on a tooth surface are graded as "initial" (ICDAS 1-2), "moderate" (ICDAS 3-4) and "extensive" (ICDAS 5-6). The indexes dmfs (decayed, missing or filled surfaces) and dmft (decayed, missing or filled surfaces) will be calculated separately for ICDAS 1-2, ICDAS 3-6 and ICDAS 1-6. The range for dmfs is 0-88 and dmft is 0-20, with 0 indicating no caries, and an increasing number indicating more carious lesions.
Awareness of the importance to maintain good oral heath
时间窗: Intervention group at 24 and 36 months of age; CHD control group at 24 and 36 months of age; healthy control group at 24 and 36 months of age.
Awareness of the importance to maintain good oral health will be measured with a questionnaire designed to assess adherence to the recommendations in the written information regarding oral health care provided at baseline in the intervention group. The questionnaire includes three domains: tooth brushing, sugar intake, and dental contact. Tooth brushing includes 6 questions (morning, night, parent brushing, problems with brushing, continue brushing though problems, fluoride tooth paste), sugar intake includes 5 questions (frequency of eating, sugary drink, eating during night, sugary food, medicine taken with sugar), and the dental contact includes one question (dental visit). Every answer not in accordance to the recommendations given, is scored with 1 point, giving a range in tooth brushing 0-6, sugar intake 0-5, and dental contact 0-1, with an increasing value indicating less awareness of the importance to maintain good oral health.
次要结局
- Orofacial dysfunction(36 months of age)
- Dental fear(36 months of age)
- Oral health related quality of life (OHRQoL)(36 months of age)
- Developmental defects of the enamel(36 months of age)
研究者
My Blomqvist
DDS, Specialist in Paediatric Dentistry, PhD
Helsinki University Central Hospital