The Children's Amalgam Trial: design and methods
The Children's Amalgam Trial: design and methods
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DOI：
10.1016/s0197-2456(03)00105-3
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发表时间：
2003-12-01
期刊：
影响因子：
--
通讯作者：
McKinlay, SM
中科院分区：
文献类型：
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作者：
McKinlay, SM
银汞合金作为牙科修复材料的安全性自 150 年前推出以来一直存在争议，但直到最近，人们一直认为接触牙科汞合金中的汞仅限于急性放置阶段。然而，最近的一些研究表明，在咀嚼和刷牙过程中，汞合金填充物会长期释放汞蒸气，从而引发了安全问题。儿童汞合金试验是一项双组随机安全性试验，将汞合金与无汞修复材料进行比较。使用单一掩蔽程序来确保所有测量结果的研究人员和工作人员都不知道指定的试验组。该研究对 534 名新英格兰儿童进行了为期 5 年的跟踪调查，这些儿童入学时年龄为 6 至 10 岁。这些孩子是从美国东北部的两个社区招募的，一处位于缅因州农村，一处位于马萨诸塞州城市。没有试验对象接受过汞合金修复，并且所有人都需要至少两次后牙咬合填充物。参与者在基线和后续就诊时被随机分配接受汞合金或复合材料用于所有后牙修复体。主要终点是 IQ 分数的 5 年变化。次要终点将包括其他神经心理学评估和肾功能的测量。本文描述了儿童汞合金试验的设计，并包括受试者基线特征的数据。 (C) 2003 Elsevier Inc. 保留所有权利。
The safety of silver amalgam as a dental restorative material has been controversial since its introduction 150 years ago, but until recently it has been assumed that the exposure to mercury from dental amalgam is limited to the acute placement phase. However, some recent studies have raised safety concerns by demonstrating chronic release of mercury vapor from amalgam fillings during chewing and brushing. The Children's Amalgam Trial is a two-arm randomized trial of safety, comparing amalgam with a mercury-free restorative material. A single masking procedure is used to ensure that all investigators and staff measuring outcomes are unaware of assigned trial arm. The study follows 534 New England children, aged 6-10 years at enrollment, for 5 years. The children were recruited from two northeastern U.S. communities, one in rural Maine and one in urban Massachusetts. No trial subjects received prior amalgam restorations, and all were in need of at least two posterior occlusal fillings. Participants were randomized to receive either amalgam or composite material for all posterior restorations at baseline and at subsequent visits. The primary endpoint will be 5-year change in IQ scores. Secondary endpoints will include measures of other neuropsychological assessments and renal functioning. This paper describes the design of the Children's Amalgam Trial and includes data on baseline characteristics of the subjects. (C) 2003 Elsevier Inc. All rights reserved.