Supplementary Material for: Early counselling to improve oral health behavior in children with major congenital heart defects – a randomized controlled trial

Maintaining optimal oral health behavior in children with a congenital heart defect (CHD) is important in managing the risk for caries development and infective endocarditis. The aim of this study was to evaluate the impact of an early and repeat oral health promotion intervention (OHPI) among of children with major CHD. Randomized controlled trial including 72 out of 91 children born in Finland 1.4.2017-31.10.2020 with a) major CHD potentially included in the criteria of endocarditis prophylaxis or b) any CHD with surgical repair combined with a chromosomal syndrome. A parallel passive control (C) group of 87 healthy children were recruited at birth. CHD children were randomized 1:1 to intervention (CHD-I) and control (CHD-C) groups. The OHPI included counselling by motivational interviewing, home delivered toothpaste and toothbrushes, and written information, and was provided at baseline, 6, 12, and 18 months of age to CHD-I group. The primary outcome measure at 24 months was child’s oral health behavior (toothbrushing, sugar intake, and dental care contact). The secondary outcome measures were parents’ awareness of the importance of oral health behavior, and oral health behavior as a predictor for child behavior. At 24 months, toothbrushing was performed twice a day in 20/27 (74%) among CHD-I, in 13/30 (43 %) among CHD-C (CHD-I vs CHD-C p=0.031), and in 37/50 (74 %) among healthy comparisons (CHD-C vs C p=0.009). Electric toothbrush use was 12/27 (44 %) in CHD-I, 5/30 (17 %) in CHD-C (CHD-I vs CHD-C p=0.041), and 7/50 (14%) in healthy comparison (CHD-C vs C p=0.756) children. Among CHD-I, toothbrushing and use of electric toothbrush improved between 12 months and 24 months. Sugar drink intake was more common among CHD-C (CHD-C vs C p=0.015), but comparable to CHD-I children. Parental toothbrushing predicted child toothbrushing twice a day. There were no statistical group differences in dental care contact. Children with CHD are at risk for poor oral health behavior. This could be improved with early and repeat oral health promotion parental counselling.维持先天性心脏病（congenital heart defect, CHD）患儿的最优口腔健康行为，对于控制龋病发病与感染性心内膜炎风险具有重要临床意义。本研究旨在评估早期重复口腔健康促进干预（oral health promotion intervention, OHPI）对重症先天性心脏病患儿的干预效果。本研究为随机对照试验，纳入2017年4月1日至2020年10月31日在芬兰出生的91名儿童中的72名，纳入标准如下：a）符合感染性心内膜炎预防指征的重症先天性心脏病；或b）合并染色体综合征且接受手术修复的任意类型先天性心脏病。同时平行设立健康被动对照（C）组，纳入87名出生时招募的健康儿童。先天性心脏病患儿按1:1比例随机分为干预组（CHD-I）与对照组（CHD-C）。口腔健康促进干预包含动机访谈咨询、家庭配送牙膏与牙刷，以及书面健康指导，分别于基线、患儿6、12及18月龄时为干预组提供上述干预。本研究的主要结局指标为24月龄时儿童的口腔健康行为，包括刷牙行为、糖摄入情况及牙科就诊情况；次要结局指标包括家长对口腔健康行为重要性的认知水平，以及口腔健康行为对儿童行为的预测性。24月龄随访结果显示：CHD-I组每日刷牙两次的儿童占比为20/27（74%），CHD-C组为13/30（43%）（CHD-I组 vs CHD-C组，p=0.031），健康对照组为37/50（74%）（CHD-C组 vs C组，p=0.009）。电动牙刷使用比例方面，CHD-I组为12/27（44%），CHD-C组为5/30（17%）（CHD-I组 vs CHD-C组，p=0.041），健康对照组为7/50（14%）（CHD-C组 vs C组，p=0.756）。在CHD-I组中，儿童的刷牙行为与电动牙刷使用率在12月龄至24月龄间有所提升。含糖饮料摄入在CHD-C组更为普遍（CHD-C组 vs C组，p=0.015），但与CHD-I组无统计学差异。家长的刷牙行为可显著预测儿童每日两次刷牙的行为。各组间牙科就诊情况无统计学差异。综上，先天性心脏病患儿存在口腔健康行为不佳的风险，通过早期重复的口腔健康促进与家长咨询可有效改善这一状况。