Health Effects of Dental Composites in Children

牙科复合材料对儿童健康的影响

• 批准号: 8449698
• 负责人: Nancy Nairi Maserejian
• 金额: $ 10.62万
• 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/8449698
• 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.

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) 相关负面影响的潜在知识空白牙科复合材料对儿童健康的影响。除了现有数据外，还将收集首次接受牙科复合修复体（与 NECAT 中使用的材料相同）的儿童 (N=110) 的新临床试验数据，以研究与尿 BPA 水平的关联，包括人体内和体内 BPA 水平。与接受诊所标准修复材料汞合金的儿童进行比较。在美国，儿童的尿 BPA 含量高于所有其他年龄段。同时，美国儿童最常见的慢性疾病是龋齿。复合修复体正迅速成为儿童龋齿的首选治疗方法，美国每年为 14 岁以下儿童植入超过 1000 万个复合修复体。而实验表明，在初次植入复合修复体后，BPA 会在短期内释放。材料，该领域的研究忽视了复合材料会随着时间的推移而降解的事实，从而在修复体或密封剂的使用寿命内产生长期、低剂量的化学物质释放的可能性。复合材料释放的化学物质对健康没有影响的普遍观念必须受到挑战，这项研究响应了全国范围内的呼吁，即利用弱势人群（从青春期前到青春期的儿童）的现有数据来研究确定 BPA 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来测试有关 6-10 岁儿童复合暴露基线和 5 年随访的假设。待测试的 BPA 相关可测量健康结果包括：体重增加（包括体重指数、体脂百分比和去脂体重的 5 年变化，N=534）、神经心理社会问题（包括经过验证的行为、情绪和个人适应问题、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，该材料已被发现释放 BPA，在体外和体内实验中具有雌激素性和/或细胞毒性。该项目将测量新的儿童样本中的尿液 BPA 含量，以确定复合材料随时间推移对尿液 BPA 的影响。关于复合材料放置、更换和修复时间的详细数据，包括材料类型（复合材料、复合体、预防性树脂修复体或密封剂）和牙齿表面水平的修复体尺寸，在半年牙科检查时记录访问。要进行的分析包括意向治疗（测试总复合修复体暴露与汞齐）和剂量反应模型（使用各种暴露措施测试单个复合材料）。 NECAT 每年都会获取有关潜在协变量的深入信息，为检查牙科复合材料对儿童人类健康的影响提供了独特、合乎道德且有效的机会。