Health Effects of Dental Composites in Children

牙科复合材料对儿童健康的影响

• 批准号: 8797585
• 负责人: Nancy Nairi Maserejian
• 金额: $ 8.57万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8797585
• 关键词: 14 year old; Accounting; Adolescence; Age; Animal Experiments; Area; Attention; Behavior; Behavioral; Biological Markers; Bis-DMA; Bisphenol A-Glycidyl Methacrylate; Body Composition; Body Weight; Body fat; Body mass index; Chemicals; Child; Child Development; Chronic; Chronic Disease; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Compomers; Composite Dental Resin; Conduct Clinical Trials; Country; Data; Dental; Dental Amalgam; Dental Materials; Dental caries; Dentistry; Development; Dose; Emotional; Endocrine Disruptors; Endocrinology; Environment; Epidemiology; Epoxy Resins; Ethics; Exposure to; Functional disorder; Funding; Health; Human; Immunology; In Vitro; Individual; Kidney; Knowledge; Life; Location; Longevity; Measurable; Measures; Memory; Mental Health; Methodology; Modeling; National Institute of Dental and Craniofacial Research; Neuropsychological Tests; Neuropsychology; New England; Obesity; Oral; Outcome; Pediatric Dentistry; Persons; Plant Resins; Population Group; Preventive; Problem behavior; Propane; Puberty; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Safety; Sampling; Source; Symptoms; System; Testing; Time; Toxicology; United States National Institutes of Health; Visit; Weight; Weight Gain; age group; aged; base; bisphenol A; boys; chemical release; cohort; composite restoration; cytotoxicity; experience; flowable hybrid composite; follow-up; girls; human population study; immune function; in vivo; indexing; innovation; monomer; neglect; neuropsychological; novel; physical conditioning; prospective; psychosocial; repaired; research study; response; restoration; restorative dentistry; restorative material; skills; tooth filling; tooth surface; urinary; visual motor

DESCRIPTION (provided by applicant): This project utilizes extant data that were collected as part of the NIH-funded New England Children's Amalgam Trial (NECAT, N=534) to help fill knowledge gaps in the potential for bisphenol A (BPA) related negative health effects of dental composites in children. In addition to extant data, new clinical trial data on children (N=110) receiving their first dental composite restorations (the same material used in NECAT) will be collected to investigate associations with urinary BPA levels, both within-person over time and in comparison to children receiving the clinic's standard restorative material, amalgam. Children have higher levels of urinary BPA than all other age groups in the U.S. Meanwhile, the most common chronic disease in U.S. children is dental caries. Composite restorations are rapidly becoming the preferred treatment for caries in children, with over 10 million composite restorations placed each year in children under the age of 14 yr in the U.S. While experiments have concluded that BPA is released in the short term following the initial placement of materials, research in this area has neglected the fact that composites degrade over time, thereby creating potential for chronic, low doses of chemicals to be released over the life of the restoration or sealant. The prevailing paradigm that chemicals released from composites have no health effects must be challenged, and this study responds to nationwide calls for research to identify the human health impact of BPA exposures using extant data from a vulnerable human population group - children from pre puberty through adolescence. This project uses both the randomized controlled trial design and prospective cohort methodologies to test hypotheses regarding composites exposure among children aged 6-10 at baseline with 5 yr of follow-up. The BPA related measurable health outcomes to be tested are: weight gain (including 5-yr changes in body mass index, body fat percentage, and lean body mass, N=534), neuropsychosocial problems (including validated measures of behavior, emotional, and personal adjustment problems, visual-motor abilities, memory index, and IQ; N=534), and an exploratory sub study (n=66) of immune function changes. NECAT used standard approved dental composite materials, which have been found to release BPA, have estrogenicity and/or cytotoxicity in vitro and in vivo experiments. This project will measure urinary BPA in a new sample of children to determine the composite's effects on urinary BPA over time. Detailed data on the timing of composites placement, replacement, and repair, including type of material (composite, compomer, preventive resin restorations, or sealants) and sizes of restorations, at the level of the tooth surface, were recorded at semi-annual dental visits. Analyses to be conducted include intent-to-treat (testing total composite restorations exposure vs. amalgam) and dose-response models (testing individual composite materials using various exposure measures). NECAT obtained in-depth information on potential covariates annually, providing a unique, ethical, and efficient opportunity to examine the human health impact of dental composites in children.

描述（由申请人提供）：本项目利用作为美国国立卫生研究院资助的新英格兰儿童汞合金试验（NECAT， N=534）的一部分收集的现有数据来帮助填补双酚A （BPA）对儿童牙齿复合材料潜在负面健康影响的知识空白。除了现有的数据，新的临床试验数据（N=110）将收集他们的第一次牙科复合修复（NECAT中使用的相同材料）的儿童（N=110），以调查尿液BPA水平的关系，包括随着时间的推移，并与接受诊所标准修复材料汞合金的儿童进行比较。与此同时，美国儿童中最常见的慢性疾病是龋齿。复合材料修复体正迅速成为儿童龋齿的首选治疗方法，在美国，每年有超过1000万的14岁以下儿童使用复合材料修复体。虽然实验得出结论，在材料的初始放置后，BPA会在短期内释放，但这一领域的研究忽视了复合材料随着时间的推移会降解的事实，从而产生慢性、低剂量的化学物质在修复或密封胶的生命周期释放。从复合材料中释放的化学物质对健康没有影响的普遍观点必须受到挑战，这项研究响应了全国范围内的研究呼吁，利用来自脆弱人群（从青春期前到青春期的儿童）的现有数据，确定BPA暴露对人类健康的影响。本项目采用随机对照试验设计和前瞻性队列方法，对6-10岁儿童在基线时接触复合材料的假设进行了5年随访。BPA相关的可测量健康结果有待测试：体重增加（包括5年体重指数、体脂百分比和瘦体重的变化，N=534），神经社会心理问题（包括行为、情绪和个人适应问题、视觉运动能力、记忆指数和智商的有效测量，N=534），以及免疫功能变化的探索性子研究（N= 66）。NECAT使用标准批准的牙科复合材料，这些材料在体外和体内实验中被发现会释放BPA，具有雌激素性和/或细胞毒性。该项目将在一个新的儿童样本中测量尿液中的BPA，以确定复合材料对尿液中BPA的长期影响。在每半年一次的牙科检查中记录有关复合材料放置、替换和修复时间的详细数据，包括材料类型（复合材料、复合材料、预防性树脂修复体或密封剂）和修复体在牙齿表面水平的大小。要进行的分析包括意向处理（测试全复合材料修复体暴露与汞合金暴露）和剂量反应模型（使用各种暴露措施测试单个复合材料）。NECAT每年获得有关潜在协变量的深入信息，为检查儿童牙科复合材料对人类健康的影响提供了独特、合乎道德和有效的机会。