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Overview
The findings of two highly anticipated clinical trials, widely known as the Children's Amalgam Trial, are presented in the April 19 issue of the Journal of American Medical Association.
The two randomized clinical trials, sponsored by the National Institutes of Health, were designed to examine the effect of mercury released from amalgam on the central and peripheral nervous systems and kidney function in children. The researchers looked for signs of damage to the brain and kidneys because these organs are thought to be the most sensitive to mercury toxicity.
The studies were dual-armed, randomized trials that compared two distinct patient populations: children from the northeastern United States and Portugal who were treated with either dental amalgam or with a mercury-free (composite) restorative material. While the participants and dentists could not be blinded to treatment assignments, the individuals who analyzed specimens or conducted outcome measures (i.e., IQ and neurobehavioral testing) were blinded.
The clinical trials recruited schoolchildren, aged 6-10 years, with 2 or more posterior teeth with dental caries and no history of exposure to amalgam. The children were randomly assigned to one of two treatment groups at two study sites: 1) New England (conducted at five dental clinics in the Boston area and Farmington, Maine); and 2) the Casa Pia school system (conducted in Lisbon, Portugal). The United States study focused on the neuropsychological (IQ) and renal effects in 534 schoolchildren, aged 6 to 10 (at the study’s outset), while the Portugal study assessed neurobehavioral and renal functions in 507 children aged 8 to 10 years (as of January 1997). Both studies evaluated the degree to which urinary mercury concentrations differed in children with and without amalgam restorations.
While the safety of dental amalgam has been the subject of a number of previous publications, expert panel meetings and national and international conferences, the two new clinical trials are the first to compare overall health effects in children treated with amalgam restorations and children treated with composite, non-amalgam restorative materials. The studies did not identify any adverse health effects related to neuropsychological function (IQ), memory, attention, visuomotor function, nerve conduction velocities or renal function arising from the placement of amalgam restorations in children.
The newly published studies lend further support to the use of dental amalgam as a safe and effective restorative treatment option. The ADA actively promotes research on the safety and effectiveness of restorative materials to ensure that the profession and the public have the most current, scientifically valid information on which to make choices about dental treatment.
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A–Z Topic: Amalgam
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A–Z Topic: Amalgam
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Science in the News is a service by the American Dental Association (ADA) to present current information about science topics in the news. The ADA is a professional association of dentists committed to the public's oral health, ethics, science and professional advancement; leading a unified profession through initiatives in advocacy, education, research and the development of standards. As a science-based organization, the ADA's evaluation of the scientific evidence may change as more information becomes available. Your thoughts would be greatly appreciated.
Page Posted April 2006
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