A Phase 3 interventional study of Dispersed phase amalgam restoration /composite restoration in Dental Caries, sponsored by Carelon Research. Completed at 1 site in United States. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2010-04-28.
Sponsored by Carelon Research · Phase 3, Interventional, and Treatment
The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only such trial in the United States, to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children.
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 (CAT) 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.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's enrollment of 534 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Carelon Research is the lead sponsor of 59 studies on the registry; 4 are open to participants now.
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IQ as measured by the WISC III Test
The record gives a start of Sep 1997 and a completion of Mar 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.
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Carelon Research