Health Effects of Dental Composites in Children

牙科复合材料对儿童健康的影响

• 批准号: 8105865
• 负责人: Nancy Nairi Maserejian
• 金额: $ 44.8万
• 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 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8105865
• 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. PUBLIC HEALTH RELEVANCE: This study uses extant data collected from 534 children who were aged 6-10 years at baseline and followed for 5 years as part of the NIH-funded New England Children's Amalgam Trial to test novel hypotheses that exposure to composite dental materials is associated with the following bisphenol A (BPA) related health outcomes: weight gain (body mass index, % body fat, and lean body mass), behavioral problems, neuropsychological function, and an exploratory study (n=66) of immune function. Associations will be examined with total exposure to composite restorations (e.g., intent to treat analysis of randomized treatment group) as well as with more specific dose-response models by type of materials (composite restorations, compomer restorations, and flowable composites as preventive restorations or sealants). Biomarker data (urinary BPA) will be collected from a new sample of 110 children treated with the same composite from the Trial's urban clinical location to determine urinary BPA exposure effects of these dental materials.

描述(由申请人提供)：该项目利用作为NIH资助的新英格兰儿童银汞合金试验(NECAT，N=534)的一部分收集的现有数据，以帮助填补双酚A(BPA)潜在的儿童牙科复合材料对健康的负面影响方面的知识空白。除了现有的数据外，还将收集关于接受第一次牙科复合修复体(与NECAT中使用的材料相同)的儿童(N=110)的新的临床试验数据，以调查与尿BPA水平之间的关系，无论是在个人内部，还是与接受诊所标准修复材料汞齐的儿童进行比较。儿童的尿双酚A水平高于美国所有其他年龄段的儿童。与此同时，美国儿童最常见的慢性疾病是龋齿。复合修复体正在迅速成为治疗儿童龋齿的首选方法，在美国，每年有超过1000万件复合修复体被放置在14岁以下的儿童身上。虽然实验得出结论，BPA在最初放置材料后短期内会释放，但这一领域的研究忽略了这样一个事实，即复合材料会随着时间的推移而降解，从而可能在修复体或密封剂的生命周期中释放长期、低剂量的化学物质。必须挑战从复合材料中释放的化学物质不会对健康产生影响的主流范式，这项研究响应了全国范围内的呼吁，即利用来自脆弱人类群体-从青春期前到青春期的儿童-的现有数据来确定双酚A暴露对人类健康的影响。该项目使用随机对照试验设计和前瞻性队列方法，对基线年龄在6-10岁的儿童中暴露于化合物的假设进行测试，并进行5年的随访。与BPA相关的可测量的健康结果是：体重增加(包括身体质量指数、身体脂肪百分比和瘦体重的5年变化，N=534)，神经心理社会问题(包括行为、情感和个人适应问题的有效测量，视觉运动能力，记忆指数和智商；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，已被发现释放BPA，在体外和体内实验中具有雌激素活性和/或细胞毒性。该项目将在一个新的儿童样本中测量尿双酚A，以确定随着时间的推移，这种化合物对尿双酚A的影响。在每半年一次的牙科就诊中，记录关于复合体放置、更换和修复的时间的详细数据，包括材料类型(复合材料、复合体、预防性树脂修复体或密封剂)和修复体的大小，在牙面水平。将进行的分析包括意向治疗(测试总的复合修复体暴露与银汞合金)和剂量-反应模型(使用各种暴露措施测试个别复合材料)。NECAT每年都会获得关于潜在协变量的深入信息，提供了一个独特、道德和有效的机会来检查儿童牙科复合体对人类健康的影响。 公共卫生相关性：作为NIH资助的新英格兰儿童汞合金试验的一部分，这项研究使用了从534名6-10岁的儿童收集的现有数据，作为NIH资助的新英格兰儿童汞齐试验的一部分，以检验新的假设，即接触复合牙科材料与以下双酚A(BPA)相关的健康结果相关：体重增加(体重指数、体脂百分比和瘦体重)、行为问题、神经心理功能，以及一项关于免疫功能的探索性研究(n=66)。将研究复合修复体的总体暴露情况(例如，随机处理组的意向治疗分析)以及按材料类型划分的更具体的剂量-反应模型(复合修复体、复合体修复体和作为预防性修复体或密封剂的可流动复合材料)的相关性。生物标记物数据(尿BPA)将从试验城市临床地点使用相同复合材料治疗的110名儿童的新样本中收集，以确定这些牙科材料的尿双酚A暴露影响。