Fluoride Varnish Reach in Early Childhood

低收入家庭和少数民族家庭儿童儿童早期龋患率较高。因为他们有 与牙科护理相比，更容易获得医疗和社会服务，我们建议实施一项 计划将氟化物清漆(FV)--一种低成本、低技术含量的防龋剂--应用于低收入人群的牙齿 社区初级保健中心(CPCCs)和加利福尼亚州特别行政区的1-3岁儿童 妇女、婴儿和儿童补充营养方案(WIC)。我们将使用分层的2x2 析因(4臂)整群随机对照临床试验48个测点：(1)现场注射FV (2)电话咨询系统(主动呼出电话) 或被动接听免费电话)对龋齿发病率和增量的影响，以及对FV预防的影响 治疗适用于1-3岁儿童。地层为CPCC或WICS。每一阶层将招收六个同意的地点 在第1-4年的每一年，总共有24个站点/层。每一层内的地点将随机分配 或者给OSFV或RFV集团。每个组内的站点将被随机分配到 主动或被动自动电话格式，用于提供对文化敏感的、语言上的 协和的照顾者咨询，以预防ECC。60名同意照看孩子的人的子样本 将在每一层的所有4个武器中从每个地点招募二人组。1-3岁的儿童将收到一份 基线和12个月随访临床牙科检查。所有牙齿的数字图像将被传输到现场以外的地方 由经过校准的牙科医生进行评估，分组分配盲法确定龋齿。基线后12个月， 每个站点的提供商将完成一份后续调查问卷和所有 来自每个地点的符合条件的1-3岁儿童的照顾者将收到后续的自动电话和 确定他们的孩子是否接受了FV。在12个月的后续行动之后，分配给RFV组的站点将是 提供了转到OSFV小组的培训。所有小组都将被跟踪6个月，以评估可及性 以及在更真实的世界条件下的可持续性。在第5年中，第1年将对计划进行评估 使用定性访谈测量的可持续性。层内和层之间的每一臂上的地点将是 比较所有符合条件的1-3岁儿童接触FV的范围， 咨询格式，以及在客户群体中的计划采用率、保真度、成本和可持续性。

hildren of low-income and minority families have high prevalence of early childhood caries. Since they have much better access to medical care and social services than to dental care, we propose to implement a program to apply fluoride varnish (FV), a low cost, low tech caries prevention agent, to the teeth of lowncome 1-3 year olds in community-based primary care centers (CPCCs) and in California Special Supplemental Nutrition Programs for Women, Infants and Children (WIC). We will use a stratified 2x2 factorial (4-arm) cluster-randomized controlled practical clinical trial of 48 sites testing: (1) FV delivery on-site (OSFV) or referring to a dentist for FV (RFV) and (2) telephone counseling systems (proactive outgoing calls or passive receptive toll-free calls) on caries incidence and increment, and on reach of FV preventive treatment in 1-3 year olds. Strata are CPCC or WICs. Six consenting sites will be enrolled in each stratum in each of Years 1-4 for a total of 24 sites/stratum. Sites within each stratum will be randomly assigned either to the OSFV or the RFV Group. Sites within each Group will be randomly assigned either to a proactive or passive automated telephone format for the provision of culturally sensitive, linguistically concordant caregiver counseling for the prevention of ECC. A sub-sample of 60 consenting child-caregiver dyads will be recruited from each site in all 4 arms of each stratum. The 1-3 year old child will receive a baseline and12-mo follow-up clinical dental exam. Digital images of all teeth will be transmitted off site for assessment by a calibrated dentist blinded to group assignment to determine caries. At 12 mo postbaseline, providers at each site will complete a follow-up questionnaire and a random sample of all caregivers of eligible 1-3 year olds from each site will receive follow-up automated phone callsand to determine if their child received FV. After the 12 mo follow-up, the sites assigned to the RFV group will be offered training to switch to an OSFV group. All groups will be followed for another 6 mo to assess reach and sustainability under more real world conditions. In year 5, Year 1 sites will be evaluated for program sustainability using qualitative interview measures. Sites in each arm within and between strata will be compared for reach of FV exposure among all eligible 1-3 year olds, for caregiver engagement with the counseling formats, and for program adoption, fidelity, cost, and sustainability across client populations.