Neurobehavioral effects of dental amalgam in children - A randomized clinical trial

Neurobehavioral effects of dental amalgam in children - A randomized clinical trial
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DOI:
10.1001/jama.295.15.1784
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发表时间:
2006-04-19
影响因子:
120.7
通讯作者:
Martins, IP
Martins, IP
中科院分区:
医学1区
文献类型:
--
作者:
DeRouen, TA;Martin, MD;Martins, IP

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牙科(银)汞合金是一种广泛使用的修复材料,含有50%的元素汞,会释放出少量的汞蒸气。没有随机临床试验已经确定是否有显着的健康风险与此低水平的汞exposition. ObjectiveTo评估的安全性,牙科汞合金fixations在children.Design一项随机临床试验中,需要牙科修复治疗的儿童被随机分配到无论是汞合金后fixations或树脂复合材料,而不是汞合金。1997年2月开始招募,每年随访7年,2005年7月结束。设置和参与者在葡萄牙的里斯本,共有507名儿童,年龄8至10岁,恒牙上至少有1处龋损,以前没有接触过汞合金,尿汞水平< 10 μ g/L,血铅水平< 15 μ g/dL,非语言智力综合测试IQ >= 67,并且没有干扰健康状况。干预常规,标准护理牙科治疗,其中一组接受了后部病变的银汞合金充填(n= 253),另一组接受了树脂复合物充填而非银汞合金充填(n= 254)主要结果测量记忆,注意力/浓度,和运动/视觉领域,以及神经传导velocity.Results在7年的试验期间,儿童的平均18.7牙齿表面(中位数,16)恢复在汞合金组和21.3(中位数,18)恢复在复合材料组的神经行为评估。汞合金组和复合材料组的基线肌酐校正平均尿汞水平分别为1.8 μ g/g和1.9 μ g/g,但在随访期间,汞合金组比复合材料组高1.0 - 1.5 μ g/g(P
Context Dental ( silver) amalgam is a widely used restorative material containing 50% elemental mercury that emits small amounts of mercury vapor. No randomized clinical trials have determined whether there are significant health risks associated with this low-level mercury exposure.Objective To assess the safety of dental amalgam restorations in children.Design A randomized clinical trial in which children requiring dental restorative treatment were randomized to either amalgam for posterior restorations or resin composite instead of amalgam. Enrollment commenced February 1997, with annual follow-up for 7 years concluding in July 2005.Setting and Participants A total of 507 children in Lisbon, Portugal, aged 8 to 10 years with at least 1 carious lesion on a permanent tooth, no previous exposure to amalgam, urinary mercury level < 10 mu g/L, blood lead level < 15 mu g/dL, Comprehensive Test of Nonverbal Intelligence IQ >= 67, and with no interfering health conditions.Intervention Routine, standard-of-care dental treatment, with one group receiving amalgam restorations for posterior lesions (n= 253) and the other group receiving resin composite restorations instead of amalgam ( n= 254).Main Outcome Measures Neurobehavioral assessments of memory, attention/ concentration, and motor/visuomotor domains, as well as nerve conduction velocities.Results During the 7-year trial period, children had a mean of 18.7 tooth surfaces ( median, 16) restored in the amalgam group and 21.3 ( median, 18) restored in the composite group. Baseline mean creatinine-adjusted urinary mercury levels were 1.8 mu g/g in the amalgam group and 1.9 mu g/g in the composite group, but during follow-up were 1.0 to 1.5 mu g/g higher in the amalgam group than in the composite group ( P