Weintraub J A, Ramos-Gomez F, Jue B, Shain S, Hoover C I, Featherstone J D B, Gansky S A
Center to Address Disparities in Children's Oral Health and Comprehensive Oral Health Research Center of Discovery, University of California, San Francisco School of Dentistry, San Francisco, CA 94143-1361, USA.
J Dent Res. 2006 Feb;85(2):172-6. doi: 10.1177/154405910608500211.
To determine the efficacy of fluoride varnish (5% NaF, Duraphat, Colgate) added to caregiver counseling to prevent early childhood caries, we conducted a two-year randomized, dental-examiner-masked clinical trial. Initially, 376 caries-free children, from low-income Chinese or Hispanic San Francisco families, were enrolled (mean age +/- standard deviation, 1.8 +/- 0.6 yrs). All families received counseling, and children were randomized to the following groups: no fluoride varnish, fluoride varnish once/year, or fluoride varnish twice/year. An unexpected protocol deviation resulted in some children receiving less active fluoride varnish than assigned. Intent-to-treat analyses showed a fluoride varnish protective effect in caries incidence, p < 0.01. Analyzing the number of actual, active fluoride varnish applications received resulted in a dose-response effect, p < 0.01. Caries incidence was higher for 'counseling only' vs. 'counseling + fluoride varnish assigned once/year' (OR = 2.20, 95% CI 1.19-4.08) and 'twice/year' (OR = 3.77, 95% CI 1.88-7.58). No related adverse events were reported. Fluoride varnish added to caregiver counseling is efficacious in reducing early childhood caries incidence.
为确定在向照顾者提供咨询指导时添加氟化物漆（5%氟化钠，Duraphat，高露洁）预防幼儿龋齿的效果，我们开展了一项为期两年的随机、牙科检查者设盲的临床试验。最初，招募了376名来自旧金山低收入中国或西班牙裔家庭的无龋儿童（平均年龄±标准差，1.8±0.6岁）。所有家庭均接受咨询指导，儿童被随机分为以下几组：不使用氟化物漆、每年使用一次氟化物漆或每年使用两次氟化物漆。一项意外的方案偏离导致一些儿童接受的活性氟化物漆少于分配剂量。意向性分析显示氟化物漆对龋齿发病率有保护作用，p<0.01。分析实际接受的活性氟化物漆应用次数产生了剂量反应效应，p<0.01。“仅咨询指导”组的龋齿发病率高于“咨询指导+每年分配一次氟化物漆”组（比值比=2.20，95%置信区间1.19 - 4.08）和“每年两次”组（比值比=3.77，95%置信区间1.88 - 7.58）。未报告相关不良事件。在向照顾者提供咨询指导时添加氟化物漆可有效降低幼儿龋齿发病率。
