Fluoride Varnish Reach in Early Childhood

低收入家庭和少数民族家庭儿童早期龋患率高。因为它们具有 我们建议推行 一种低成本、低技术含量的防龋剂--氟化物保护漆（FV）， 1-3社区初级保健中心（CPCC）和加州的20岁奥尔兹 妇女、婴儿和儿童补充营养方案。我们将使用分层的2x2 48个研究中心的析因（4组）随机分组对照临床试验：（1）现场FV给药 （OSFV）或指牙医进行FV（RFV）和（2）电话咨询系统（主动呼出电话 或被动接受免费电话）对龋病发病率和增加，以及FV预防的可及性 1-3奥尔兹的治疗。层是CPCC或WIC。每个分层将入组6家知情同意的研究中心 在第1-4年的每一年，共24个地点/层。每个层内的研究中心将被随机分配 或者是OSFV或者RFV集团。每组内的研究中心将被随机分配到 主动或被动的自动电话格式，以提供文化上敏感、语言上 和谐的照顾者咨询，以预防ECC。60名同意的儿童看护者的子样本 将从每个研究中心每个层的所有4个组中招募二联体。1-3岁的儿童将获得 基线和12个月随访的临床牙科检查。所有牙齿的数字图像将被传输到场外， 由不知道分组的校准牙医进行评估以确定龋齿。基线后12个月， 每个研究中心的提供者将完成一份后续调查问卷，并随机抽取所有 每个研究中心符合条件的1-3奥尔兹的护理人员将收到后续自动电话， 确定孩子是否接受了FV。12个月随访后，分配到RFV组的部位将 提供培训，以切换到一个OSFV组。将对所有组再随访6个月，以评估达到 和可持续性在更真实的世界条件下。在第5年，将对第1年的研究中心进行项目评估 可持续性使用定性访谈措施。每个组的层内和层间研究中心将 比较所有符合条件的1-3奥尔兹的FV暴露范围， 咨询格式，并为程序采用，忠诚度，成本和可持续性的客户群体。

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.