Sugar Sweetened Beverages and Recurrent Severe Early Childhood Caries

描述(申请人提供)：幼儿严重早期龋齿的治疗(S-ECC)由于在牙科诊所缺乏儿童合作，越来越多地需要在全身麻醉(GA)下进行牙科治疗。然而，这种方法并不能控制疾病，临床结果很差，大多数儿童在两年内出现新的龋损，有些甚至需要在GA下重新治疗。增加这些儿童的无病生存时间将允许儿童获得社会和自我 应对办公室内牙科治疗的管理技能，避免GA下另一次创伤性和昂贵的治疗事件。糖类，特别是含糖饮料(SSB)中的外源性糖类，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临床试验计划补助金的目标是设计一项二期随机对照试验，以评估与护理标准相比，环境饮食和行为改变干预在提高GA牙科治疗后S-ECC儿童无龋性生存时间方面的有效性。实验干预包括将含氟的普通水装在有吸引力的瓶子里送到家里，并结合父母的饮食咨询，旨在减少SSB的摄入量和增加水的摄入量。它以社会生态学和行为控制理论(家庭方法的模型)为基础，通过改变家庭环境、父母角色示范和增加与健康饮食相关的知识来引入新的家庭规范。主要结果是在2年的随访中龋齿复发的时间。具体目标是：1)使用NIDCR介入临床方案模板开发和编写随机对照试验临床方案。2)根据华盛顿大学(UW)和NIDCR的要求，协调IRB对研究方案、相关同意文件和招聘材料的审查和批准。3)制定临床监测计划，确保研究程序的准确性。4)编写程序手册(MOP)，包括干预措施及其质量管理的内容、交付和监测(标准操作程序(SOP)试验针对2020年健康人目标(OH-1、OH-2)和NIDCR战略计划目标(I-2、II-3、III-1、IV-1、IV-2)，包括减少乳牙的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案中关于学校免费饮用水的要求的补充，也是对第一夫人的倡议--让我们行动起来！这是华盛顿大学西北中心与华盛顿大学儿科牙科中心、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(ITHS)合作开展的一个旨在减少口腔健康差距的项目。

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).