Child Dental BPA Study (BPARCS)

儿童牙科 BPA 研究 (BPARCS)

• 批准号: 9277070
• 负责人: Christy Michelle McKinney
• 金额: $ 38.49万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9277070
• 关键词: 8 year old; Address; Adult; Adverse event; Affect; Aftercare; American; Anesthesia procedures; Biological; Bisphenol A-Glycidyl Methacrylate; Brain; Chemicals; Child; Child health care; Childhood; Cognitive; Data; Decision Making; Dental; Dental Anesthesia; Dental Materials; Dose; Endocrine; Ensure; Exposure to; General Anesthesia; Goals; Health; Height; Hour; Human; Intervention; Lead; Masks; Measures; Medical; Medical Device; Mouth Diseases; Nitrous Oxide; Patients; Pediatric Dentistry; Plant Resins; Prospective Studies; Records; Recruitment Activity; Research; Safety; Sampling; Sedation procedure; Source; Surface; Surveys; Syringes; Time; Toxic effect; Tube; Universities; Washington; Weight; base; bisphenol A; follow-up; food security; high risk; improved; innovation; psychologic; public health relevance; reproductive; reproductive development; restoration; restorative dentistry; therapy design; urinary; xenoestrogen

 DESCRIPTION (provided by applicant): More than 29 million children have a dental restoration. The majority of restorations now placed are composites. Most resin-based composites placed in children contain a derivative of Bisphenol A (BPA) called BPA-glycidyl methacrylate (BisGMA). When BisGMA was developed in 1962, no studies were required by the FDA to evaluate biological toxicity. BPA is a widespread xenoestrogen that may affect brain, endocrine, and reproductive development. National dental organizations maintain the amount of BPA from BisGMA-based dental materials is too small to be relevant to human health. There is scant scientific evidence for or against this assertion. Contrary to this claim, our pilot data and data from the only other prospective study in children show urinary BPA (uBPA) concentrations are a magnitude of 2 to 6-fold higher post-treatment. Studies show exposure to medical products increase BPA concentrations, yet there are no studies in children that quantify BPA exposure from medical products used in anesthesia (tubes, syringes) for dental treatment. We need to determine the contribution of dental-related BPA exposure to overall BPA load, and distinguish between different sources of dental-related BPA exposure. The aims of this application are to: (1) Quantify the magnitude and duration of BPA exposure resulting from dental treatment; (2) Determine associations between number of BisGMA-based treated surfaces and BPA, overall and by type of material (composites, sealants); and (3) Determine the association between type of anesthesia and BPA. We will measure uBPA concentrations in 210 children 4 to 8 years old receiving BisGMA-based dental materials with different types of sedation at the University of Washington Center for Pediatric Dentistry 2 times before and 4 times after treatment from 24 hours to 16 weeks. To ensure we have sufficient numbers of highly exposed children we will employ stratified sampling. We will recruit children who are treated with <4 surfaces (n=105) and =4 surfaces (n=105) with BisGMA-based dental materials. Within each of these two groups, we will recruit 35 patients in three groups who receive: (1) no sedation, (2) nitrous oxide; or (3) general anesthesia. We will administer surveys to collect demographic data and data on food security and other sources of BPA. We will measure the height and weight of the child, and collect detailed treatment records. We will conduct the first large study in children to comprehensively examine multiple sources of dental-related BPA exposure. Distinguishing BPA from dental materials and medical products used in anesthesia may enable us to develop interventions to reduce dental-related BPA exposure. By oversampling children receiving treatment on =4 surfaces with BisGMA-based dental materials and children receiving GA, we will include high-risk children likely to have high baseline BPA who may receive among the largest amounts of dental-related BPA exposure from materials or anesthesia, and who may be most likely to experience adverse health effects from BPA.

 描述（由申请人提供）：超过 2900 万儿童进行了牙齿修复，目前大多数植入儿童的树脂基复合材料都含有双酚 A (BPA) 衍生物，称为 BPA-甲基丙烯酸缩水甘油酯 (BisGMA)。 1962 年开发 BisGMA 时，FDA 并未要求进行研究来评估 BPA 是一种可能影响广泛的异雌激素。国家牙科组织认为，基于 BisGMA 的牙科材料中的 BPA 含量太少，与人类健康无关，但与这一说法相反，没有足够的科学证据。数据和 另一项针对儿童的前瞻性研究的数据显示，治疗后尿液中的 BPA (uBPA) 浓度增加了 2 至 6 倍。 研究表明，接触医疗产品会增加 BPA 浓度，但尚无针对儿童的研究对 BPA 进行量化。牙科治疗麻醉中使用的医疗产品（管子、注射器）的暴露 我们需要确定与牙科相关的 BPA 暴露对总体 BPA 负荷的贡献，并区分与牙科相关的 BPA 暴露的不同来源。 (1) 量化牙科治疗导致的 BPA 暴露程度和持续时间；(2) 确定基于 BisGMA 的处理表面数​​量与 BPA 之间的总体关联和材料类型（复合材料、密封剂）；以及 (3) ) 确定麻醉类型与 BPA 之间的关联 我们将在华盛顿大学测量 210 名 4 至 8 岁儿童接受基于 BisGMA 的牙科材料和不同类型镇静剂的 uBPA 浓度。儿童牙科中心 治疗前 2 次，治疗后 24 小时至 16 周 4 次 为了确保我们有足够数量的高度暴露儿童，我们将采用分层抽样的方式招募接受 <4 个表面治疗的儿童（n = 105）。 ）和= 4个表面（n = 105），使用基于BisGMA的牙科材料在这两组中，我们将招募三组中的35名患者，他们接受：（1）不镇静，（2）一氧化二氮；或 (3) 全身麻醉 我们将进行调查，收集有关食品安全和其他 BPA 来源的数据。 我们将测量儿童的身高和体重，并收集详细的治疗记录。第一项针对儿童的大型研究全面检查了与牙科相关的 BPA 暴露的多种来源，将 BPA 与麻醉中使用的牙科材料和医疗产品区分开来，可以通过对 =4 接受治疗的儿童进行过采样来制定干预措施，以减少与牙科相关的 BPA 暴露。表面有基于 BisGMA 的牙科材料和接受 GA 的儿童，我们将包括可能具有高基线 BPA 的高风险儿童，他们可能从材料或麻醉中接触到最大量的牙科相关 BPA 暴露，并且最有可能经历不良反应BPA 对健康的影响。