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）：本项目利用NIH资助的新英格兰儿童汞合金试验（NECAT，N=534）收集的现有数据，以帮助填补儿童牙科复合材料对双酚A（BPA）相关负面健康影响的潜在知识空白。除了现有的数据，新的临床试验数据的儿童（N=110）接受他们的第一次牙科复合材料（在NECAT中使用的相同材料）将被收集，以调查与尿BPA水平的关联，无论是在人随着时间的推移，并与儿童接受诊所的标准修复材料，汞合金。在美国，儿童的尿BPA水平高于所有其他年龄组。同时，美国儿童最常见的慢性疾病是龋齿。复合材料牙釉质正迅速成为儿童龋齿的首选治疗方法，在美国，每年有超过1000万个复合材料牙釉质被放置在14岁以下的儿童中。虽然实验得出结论，BPA在最初放置材料后的短期内释放，但该领域的研究忽略了复合材料随时间降解的事实，从而产生慢性、慢性和慢性牙釉质龋的可能性。在修复体或密封剂的使用寿命期间释放低剂量的化学品。从复合材料中释放的化学物质对健康没有影响的流行范式必须受到挑战，这项研究响应了全国范围内的研究呼吁，利用脆弱人群的现有数据确定BPA暴露对人类健康的影响-青春期前到青春期的儿童。 本项目采用随机对照试验设计和前瞻性队列研究方法，对6-10岁儿童基线时复合暴露的假设进行了5年随访。待测试的BPA相关可测量的健康结果是：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），神经心理社会问题（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，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。该项目将测量一个新的儿童样本的尿BPA，以确定随着时间的推移，复合物对尿BPA的影响。在每半年一次的牙科就诊时记录关于复合材料放置、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、预防性树脂牙釉质或密封剂）和牙面水平牙釉质的尺寸。将要进行的分析包括意向治疗（测试总复合材料暴露与汞合金暴露）和剂量反应模型（使用各种暴露措施测试个别复合材料）。NECAT每年获得关于潜在协变量的深入信息，为研究牙科复合材料对儿童人体健康的影响提供了一个独特的、符合道德规范的、有效的机会。 公共卫生相关性：这项研究使用了从534名儿童中收集的现有数据，这些儿童在基线时年龄为6-10岁，并作为NIH资助的新英格兰儿童汞合金试验的一部分进行了5年的随访，以测试接触复合牙科材料与以下双酚A（BPA）相关健康结局相关的新假设：体重增加（体重指数、%体脂和瘦体重）、行为问题、神经心理功能和免疫功能的探索性研究（n=66）。将检查与综合风险的总暴露的关联（例如，随机化治疗组的意向治疗分析）以及通过材料类型（复合物稀释剂、复合物稀释剂和作为预防性稀释剂或密封剂的可流动复合物）的更具体的剂量反应模型。生物标志物数据（尿BPA）将从试验城市临床地点接受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BPA暴露效应。