Supplementary Material for: Clinical Effect of Two Fluoride Varnishes in Caries-Active Preschool Children: A Randomized Controlled Trial

The prevention of dental caries in preschool children is a priority for dental services. The aim of the study was to investigate the caries-preventive effect of 2 fluoride varnishes in caries-active preschool children, and then compare the outcome with a non-varnish control group. After screening, 180 preschool children aged 36–71 months, with at least 1 noncavitated lesion, were enrolled and randomly allocated into 3 parallel groups, namely A: 1.5% ammonium fluoride varnish (Fluor Protector S), B: 5% NaF varnish (Duraphat), and C: professional tooth-cleaning. All children were recalled every third month for intervention and their parents were instructed to have them brush their teeth with a 1,000-ppm fluoride toothpaste twice daily. Caries were recorded at baseline and after 12 months by a calibrated examiner and the incidence was scored on noncavitated (d2) and cavitated (d3) level. We tested differences between the groups with the χ2 and two-sided t tests. One hundred and seventy-two children (95.6%) completed the trial and 56 (32.6%) and 35 (19.2%) developed new d2 and d3 lesions, respectively. Both varnishes reduced the incidence of caries compared with the control group, but there was no significant difference between group A and group B. Compared with group C, the relative risk for developing cavitated lesions was 0.39 (95% CI 0.22–0.62) in group A and 0.26 (95% CI 0.14–0.50) in group B. The total prevented fraction (Δd2d3mft) for group A and group B was 19.9 and 22.5% (p < 0.05), respectively. No adverse effects were observed or reported during the study period. In conclusion, the 2 fluoride varnishes demonstrated an equal capacity to reduce the incidence of caries in caries-active preschool children over a 12-month period in comparison with a control group.

学龄前儿童龋齿预防是牙科医疗服务的核心要务。本研究旨在探究两种氟化物涂剂（Fluoride Varnish）在龋活跃性学龄前儿童中的防龋效果，并与未使用氟化物涂剂的对照组进行疗效对比。经筛选后，共计180名年龄介于36至71个月、存在至少1处非龋洞性病损的学龄前儿童入组，采用随机分组法分为3个平行组：A组为1.5%氟化铵涂剂（Fluor Protector S），B组为5%氟化钠涂剂（Duraphat），C组为专业洁牙。所有研究对象每3个月复诊接受一次干预，同时由研究人员指导其家长每日使用1000ppm含氟牙膏为儿童刷牙两次。由经过校准的检查人员在基线期及12个月随访时记录龋病情况，并以非龋洞病损（d2）与龋洞病损（d3）两个层级评估龋病发生率。本研究采用卡方（χ²）检验与双侧t检验对各组间的差异进行分析。最终共有172名儿童（95.6%）完成本试验，其中分别有56名（32.6%）与35名（19.2%）出现新发d2与d3病损。相较于对照组，两种氟化物涂剂均能降低龋病发生率，但A组与B组之间未观察到显著差异。以C组为参照，A组出现龋洞病损的相对风险为0.39（95%置信区间0.22–0.62），B组则为0.26（95%置信区间0.14–0.50）。A组与B组的总防龋率（Δd2d3mft）分别为19.9%与22.5%（p < 0.05）。整个研究周期内未观察到或报告任何不良事件。综上，与对照组相比，两种氟化物涂剂在为期12个月的随访中，对龋活跃性学龄前儿童均展现出同等的龋病发生率降低效果。