Health Effects of Dental Composites in Children

牙科复合材料对儿童健康的影响

• 批准号: 8248658
• 负责人: Nancy Nairi Maserejian
• 金额: $ 30.61万
• 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/8248658
• 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; public health relevance; 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）：该项目利用了现有的数据，这些数据是NIH资助的新英格兰儿童amalgam试验（NECAT，n = 534）的一部分，以帮助填补儿童牙科复合物对牙科复合材料的相关负面健康影响的潜在的知识差距。除了现有数据外，还将收集有关儿童的新临床试验数据（n = 110）（n = 110），将收集其第一个牙科复合修复体（NECAT中使用的材料相同），以调查与尿中BPA水平的关联，并与接受诊所标准修复材料的儿童相比，与尿中的BPA水平相关。同时，儿童的尿BPA水平高于美国所有其他年龄段，美国儿童中最常见的慢性疾病是龋齿。 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.从复合材料中释放的化学物质的普遍范式必须没有挑战，这项研究对全国范围内的研究呼吁进行研究，以确定使用来自脆弱的人口群体中的现有数据（来自青春期前青春期前的青春期儿童）的人类健康影响。 该项目同时使用随机对照试验设计和前瞻性队列方法来检验有关基线时6-10岁儿童的复合材料暴露的假设，并进行了5年的随访。 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使用的标准批准的牙科复合材料（已被发现释放BPA）在体外和体内实验具有雌激素和/或细胞毒性。该项目将在新的儿童样本中测量尿BPA，以确定综合对尿液BPA的影响。关于复合材料放置，更换和修复时间的详细数据，包括材料的类型（复合，复合物，预防树脂修复物或密封剂）和在牙齿表面的水平上的尺寸，在半年牙齿探访中记录了牙齿表面的尺寸。要进行的分析包括意向性治疗（测试总复合修复体暴露与汞合金）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，提供了一个独特，道德和高效的机会，以检查儿童牙科复合材料对人类健康的影响。 公共卫生相关性：本研究使用了从基线时6-10岁的534名儿童收集的现有数据，随后是NIH资助的新英格兰儿童amalgam试验的一部分，以测试新的假设，即暴露于复合牙科材料的新假设与以下相关的健康状况相关的是体重，体重增加的体重（BOSPANOL A（BPA）相关的体重（体重），体重增加（体重），体重增加，体重，体重，体重，体重，体重，体重，体重，体重，体重，体重，体重，体重，体重，体重，体重增加，和体重）功能和免疫功能的探索性研究（n = 66）。将检查关联，以全面暴露于复合修复体（例如，目的是治疗随机治疗组的分析）以及通过材料类型（复合修复，综合修复体和可流动复合材料作为预防性修复物或密封剂）的更具体的剂量反应模型）。将从试验的城市临床位置的110名儿童的新样本中收集生物标志物数据（尿BPA），以确定这些牙科材料的尿BPA暴露效应。