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Home > "T" Clinical Trials Conditions > The Children's Amalgam Trial  The Children's Amalgam Trial
The Children's Amalgam Trial
For Condition: Dental Caries
Status: No longer recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 6 Years/10 Years
Genders: Both
Protocol Entry Criteria: - 6 - 10 years of age at last birthday - Fluent in English - No prior or existing amalgam restorations - Two or more posterior teeth with dental caries such that restoration would include the occlusal surfaces - No clinical evidence of existing psychological, behavioral, neurologic, immunosuppressive, or renal disorders.
Total Enrollment: 534
Location and Contact Information:
New England Research Institute
Watertown, Massachusetts, 02472
United States
Additional Information:
Study ID Numbers: NIDCR-11886;
Study Start Date: September 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065988
Other Dental Caries Studies:
1. Caries Transmission Prevention in Alaska Native Infants
2. Evaluation of Implants Placed Immediately or Delayed into Extraction Sites
3. Study of the Composition of Dental Plaque
4. Fluoride Varnish Study
5. Prevention Management Model for Early Childhood Caries (MAYA Project)
Related Studies:
Other Dental Caries Clinical Trials
Other Massachusetts Clinical Trials
Other Watertown Clinical Trials
The Children's Amalgam Trial
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