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

冠状病毒病2019(新冠肺炎)是一种大流行，目前没有预防或治疗方法，对个人和社会造成前所未有的破坏和代价。新冠肺炎“帮助消除/减少儿童口腔健康不平等协调中心”(CC)(U01DE025507)行政副刊将利用协作研究和协调中心的专业知识和服务，向加州大学校长办公室(UCOP)审查和加州乳腺癌研究计划资助(R00RG2901)的试点试验提供合作研究和服务，以评估消毒漱口水对病毒载量的影响。来自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在手术前使用杀菌冲洗，尽管没有经验的临床证据。这项拟议的行政补充文件将具体涉及NOTDE-20-022“对可能限制SARSCoV-2传染性的现有口腔微生物区系治疗调节剂的试点测试”中的项目。CC团队在临床试验、流行病学、生物统计学、临床研究和口腔健康方面拥有相关的跨学科专业知识，以及为NIH研究联盟的多个健康和口腔健康项目提供服务的数据协调中心的经验。作为NIDCR儿童口腔健康差异(OHDC)联盟的协调中心，该团队已经展示了其协作和创造性地支持大规模、临床相关的预防试验研究的能力，同时在9项UH2研究中，然后在3个时区的6个机构的4项UH3随机临床试验中，以满足总体科学和项目界合作伙伴的目标。协调委员会将与试点项目小组建立持续的合作关系，以便在下列领域提供服务和专门知识：(A)与口腔健康有关的临床知识；(B)特别注重不同人群健康结果的量化研究设计；(C)选择、开发和改进测量仪器；(D)信息学，包括提供安全、定制的数据采集系统、项目管理和临床试验管理系统；(E)使用这些系统的培训；(F)参与者安全监测和向项目调查人员报告；(G)数据管理、处理和质量控制；(H)完善量化数据分析计划；(I)向项目调查员报告试验进展情况；(J)进行统计分析，包括估计任何后续试验的样本量。我们经验丰富的协调中心团队可以为这项由UCOP资助的试点试验提供高效、全面的支持，该试验可以提供关键知识，形成经验基础，以制定战略，潜在地惠及医护人员、一线工作人员、免疫功能低下者(包括乳腺癌患者)等高危个人以及受健康差距影响的群体。

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.