Neuropsychological and Renal Effects of Dental Amalgam in Children: A Randomized Clinical Trial

CONTEXT No randomized trials have been published that address the concern that inhalation of mercury vapor released by amalgam dental restorations causes adverse health effects. OBJECTIVE To compare the neuropsychological and renal function of children whose dental caries were restored using amalgam or mercury-free materials. DESIGN AND SETTING The New England Children's Amalgam Trial was a 2-group randomized safety trial involving 5 community health dental clinics in Boston, Mass, and 1 in Farmington, Me, between September 1997 and March 2005. PARTICIPANTS AND INTERVENTION A total of 534 children aged 6 to 10 years at baseline with no prior amalgam restorations and 2 or more posterior teeth with caries were randomly assigned to receive dental restoration of baseline and incident caries during a 5-year follow-up period using either amalgam (n=267) or resin composite (n =267) materials. MAIN OUTCOME MEASURES The primary neuropsychological outcome was 5-year change in full-scale IQ scores. Secondary outcomes included tests of memory and visuomotor ability. Renal glomerular function was measured by creatinine-adjusted albumin in urine. RESULTS Children had a mean of 15 tooth surfaces (median, 14) restored during the 5-year period (range, 0-55). Assignment to the amalgam group was associated with a significantly higher mean urinary mercury level (0.9 vs 0.6 μg/g of creatinine at year 5, P