title: Neuropsychological and renal effects of dental amalgam in children: a randomized clinical trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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 microg/g of creatinine at year 5, P<.001). After adjusting for randomization stratum and other covariates, no statistically significant differences were found between children in the amalgam and composite groups in 5-year change in full-scale IQ score (3.1 vs 2.1, P = .21). The difference in treatment group change scores was 1.0 (95% confidence interval, -0.6 to 2.5) full-scale IQ score point. No statistically significant differences were found for 4-year change in the general memory index (8.1 vs 7.2, P = .34), 4-year change in visuomotor composite (3.8 vs 3.7, P = .93), or year 5 urinary albumin (median, 7.5 vs 7.4 mg/g of creatinine, P = .61).
  
  
  CONCLUSIONS
  In this study, there were no statistically significant differences in adverse neuropsychological or renal effects observed over the 5-year period in children whose caries were restored using dental amalgam or composite materials. Although it is possible that very small IQ effects cannot be ruled out, these findings suggest that the health effects of amalgam restorations in children need not be the basis of treatment decisions when choosing restorative dental materials.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00065988.
authors.affiliation: Department of Neurology, Children's Hospital Boston, and Harvard Medical School, Boston, Mass, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Bellinger
authors.forename: Felicia
authors.initials: F
authors.lastname: Trachtenberg
authors.forename: Lars
authors.initials: L
authors.lastname: Barregard
authors.forename: Mary
authors.initials: M
authors.lastname: Tavares
authors.forename: Elsa
authors.initials: E
authors.lastname: Cernichiari
authors.forename: David
authors.initials: D
authors.lastname: Daniel
authors.forename: Sonja
authors.initials: S
authors.lastname: McKinlay
mesh_terms: D002648:Child; D003723:Dental Amalgam / Q000009:adverse effects / Q000737:chemistry; D003731:Dental Caries / Q000628:therapy; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008137:Longitudinal Studies; D008297:Male; D008628:Mercury / Q000032:analysis / Q000493:pharmacokinetics; D008630:Mercury Poisoning / Q000175:diagnosis / Q000209:etiology*; D009483:Neuropsychological Tests; D019279:Resin Cements / Q000009:adverse effects; D014835:Volatilization
chemical_list: D019279:Resin Cements; D003723:Dental Amalgam; D008628:Mercury