COORDINATING CENTER TO HELP ELIMINATE/REDUCE ORAL HEALTH INEQUALITIES IN CHILDREN

2019冠状病毒病（COVID-19）是一种目前没有预防或治疗方法的大流行病，对个人和社会造成前所未有的破坏和成本。这是COVID-19行政补充“协调中心，以帮助消除/减少儿童口腔健康不平等”（CC）（U 01 DE 025507）将利用合作研究和协调中心的专业知识和服务，以加州大学校长办公室（UCOP）审查和加州乳腺癌研究计划资助（R 00 RG 2901）评估SARS-CoV-2感染病毒载量成人的抗菌漱口水的初步试验。美国疾病控制和预防中心和美国牙科协会的初步指导建议牙科提供者让患者使用术前抗菌冲洗，尽管没有经验性临床证据。本拟议行政补充文件将专门针对NOTDE-20-022中的项目“可能限制SARSCoV-2感染性的现有口腔微生物群治疗调节剂的初步试验”。CC团队拥有临床试验，流行病学，生物统计学，临床研究和口腔健康方面的相关跨学科专业知识，以及在NIH研究联盟中服务多个健康和口腔健康项目的数据协调中心经验。作为NIDCR儿童口腔健康差异（OHDC）联盟的协调中心，该团队已经证明了其合作和创造性支持大规模，临床相关的预防试验研究的能力，同时在9项UH 2研究中，然后在3个时区的6个机构的4项UH 3随机临床试验中，以满足整体科学和项目社区合作伙伴的目标。协调委员会将与试点项目小组建立持续的合作关系，在以下领域提供服务和专业知识：（a）与口腔健康相关的临床知识;（B）定量研究设计，特别强调不同人群的健康结果;（c）选择、开发和改进测量工具;（d）评估和评估口腔健康状况。（d）信息学，包括提供安全、定制的数据采集系统以及项目管理和临床试验管理系统;（f）参与者安全监测和向项目调查员报告;（g）数据管理、处理和质量控制;（h）完善定量数据分析计划;（i）向项目调查员报告试验进展情况;以及（j）进行统计分析，包括任何后续试验的样本量估计。我们经验丰富的协调中心团队可以为这项UCOP资助的试点试验提供有效，全面的支持，该试验可以提供关键知识，以形成经验基础，从而制定可能使医疗保健工作者，一线工作人员，高风险个体（如免疫功能低下的人）（包括乳腺癌患者）和受健康差异影响的群体受益的策略。

Coronavirus Disease 2019 (COVID-19) is a pandemic currently without preventive or curative treatments, causing unprecedented disruption and costs to individuals and society. This COVID-19 Administrative Supplement to the “Coordinating Center to Help Eliminate/Reduce Oral Health Inequalities in Children” (CC) (U01DE025507) will leverage collaborative research and coordinating center expertise and services to a University of California Office of the President (UCOP) reviewed and California Breast Cancer Research Program funded (R00RG2901) pilot trial to assess antiseptic mouthwashes in SARS-CoV-2 infected adults on viral load. Initial guidance from US Centers for Disease Control and Prevention and American Dental Association recommended dental providers have patients use a pre-procedural antiseptic rinse, despite no empirical clinical evidence. This proposed administrative supplement will specifically address the item in NOTDE-20-022 “Pilot testing of existing therapeutic modulators of oral microbiota that may limit infectivity of SARSCoV-2”. The CC team possesses relevant transdisciplinary expertise in clinical trials, epidemiology, biostatistics, clinical research, and oral health, as well as data coordinating center experience serving multiple health and oral health projects in NIH research consortia. As the NIDCR Oral Health Disparities in Children (OHDC) Consortium’s Coordinating Center the team has demonstrated its ability to collaboratively and creatively support large-scale, clinically-relevant, prevention trial research simultaneously in 9 UH2 studies and then in 4 UH3 randomized clinical trials in 6 institutions across 3 time zones to meet the overall scientific and project community partner goals. The CC will establish ongoing, collaborative relationships with the pilot project team to provide services and expertise in the following areas: (a) oral health-related clinical knowledge; (b) quantitative research design with particular emphasis on health outcomes in diverse populations; (c) selecting, developing, and refining measurement instruments; (d) informatics, including providing secure, customized data acquisition systems and project management and clinical trials management systems; (e) training in the use of those systems; (f) participant safety monitoring and reporting to the project investigators; (g) data management, processing, and quality control; (h) refining quantitative data analysis plans; (i) reporting on trial progress to the project investigators; and (j) perform statistical analyses including sample size estimation for any follow-up trials. Our experienced Coordinating Center team can provide efficient, comprehensive support to this UCOP funded pilot trial which could provide critical knowledge to form the empirical foundation to develop strategies to potentially benefit health care workers, frontline workers, high risk individuals such as immunocompromised people (including breast cancer patients), and groups impacted by health disparities.