Sugar Sweetened Beverages and Recurrent Severe Early Childhood Caries

描述（由申请人提供）：由于在牙科诊所环境中缺乏儿童合作，患有严重幼儿龋齿（S-ECC）的幼儿的治疗越来越多地涉及全身麻醉（GA）下的牙科治疗。然而，这种方法不能控制疾病，临床结果很差，大多数儿童在两年内出现新的龋齿病变，有些甚至需要在GA下进行再治疗。增加这些儿童的无病生存时间将使他们获得社会和自我能力。 管理技能，以科普在办公室牙科治疗，避免另一个创伤和昂贵的治疗事件根据GA。糖，特别是糖甜化甜菜碱（SSB）中所含的外源性糖，已被认为是S-ECC的主要原因，但缺乏有效和有效的饮食干预试验。这项R34临床试验计划资助的目的是设计一项II期随机对照试验，以评估与标准治疗相比，环境饮食和行为改变干预对增加S-ECC儿童在GA下牙科治疗后的无龋生存时间的有效性。实验性干预包括将装在有吸引力的瓶子中的氟化白开水送到家中，并结合父母的饮食咨询，旨在减少SSB的消耗和增加水的摄入量。它以社会生态学和行为控制理论（家庭方法模型）为基础，通过改变家庭环境、父母角色模型和增加与健康饮食有关的知识来引入新的家庭规范。主要结果是在2年随访期间龋齿复发的时间。具体目的是：1）使用NIDCR介入临床方案模板开发和编写RCT临床方案。 2)按照华盛顿大学（UW）和NIDCR的要求，协调IRB审查和批准研究方案、相关知情同意文件和招募材料。 3)制定临床监查计划，以确保研究程序的准确性。 4)编写程序手册（MOP），包括干预的内容、交付和监测及其质量管理（标准操作规程（SOP））该试验旨在实现2020年健康人群目标（OH-1、OH-2）和NIDCR战略计划目标（I-2、II-3、III- 1、IV-1、IV-2），包括减少乳牙龋齿和消除口腔健康方面的差异。这也是对2010年联邦《健康无饥饿儿童法》中关于学校免费饮用水的要求和第一夫人的“让我们行动起来！”倡议的补充。这是华盛顿西北中心大学与华盛顿大学儿童牙科中心、华盛顿大学公共卫生营养中心和华盛顿大学转化健康科学研究所（UWS）合作减少口腔健康差异的一个项目。

DESCRIPTION (provided by applicant): Treatment of young children with Severe Early Childhood Caries (S-ECC) increasingly involves dental treatment under General Anesthesia (GA) due to lack of child cooperation in dental office settings. However, this approach does not control the disease and clinical outcomes are poor with most children developing new caries lesions within two years and some even necessitating retreatment under GA. Increasing disease-free survival time for these children would permit the child to acquire the social and self management skills to cope with in-office dental treatment, avoiding another traumatic and costly treatment episode under GA. Sugars, and particularly extrinsic sugars as those contained in Sugar Sweetened Beverages (SSBs), have been implicated as a major cause of S-ECC, yet trials of efficacious and effective dietary interventions are lacking. The objective of this R34 Clinical Trial Planning Grant is to design a Phase II RCT to assess the efficacy of an environmental dietary and behavioral change intervention, compared with the standard of care, on increasing caries-free survival time in children with S-ECC after dental treatment under GA. The experimental intervention consists of home delivery of fluoridated plain water in attractive bottles in combination with parental dietary counseling aimed to reduce SSB consumption and increase water intake. It is based on socioecological and behavior control theories (model of familial approach) to introduce new familial norms through making changes within the home environment, parental role-modeling, and increasing knowledge related to healthy eating. The primary outcome is time to relapse of dental caries during the 2-year follow up. The Specific Aims are to: 1) Develop and write the RCT clinical protocol using the NIDCR Interventional Clinical Protocol Template. 2) Coordinate IRB review and approval of the study protocol, associated consent documents and recruitment materials as required by the University of Washington (UW) and NIDCR. 3) Develop a plan for clinical monitoring to ensure fidelity of study procedures. 4) Write the Manual of Procedures (MOP) including the content, delivery, and monitoring of the intervention and its quality management (Standard Operating Procedures (SOP) The trial addresses Healthy People 2020 goals (OH-1, OH-2) and NIDCR strategic plan objectives (I-2, II-3, III- 1, IV-1, IV-2), including to reduce dental caries in primary teeth and o eliminate disparities in oral health. It is also complementary to requirements under the federal Healthy Hunger-Free Kids Act of 2010 for free drinking water in schools and the First Lady's initiative Let's Move! This is a project of the University of Washington Northwest Center to Reduce Oral Health Disparities in collaboration with UW Center for Pediatric Dentistry, UW Center for Public Health Nutrition and UW Institute for Translational Health Sciences (ITHS).