ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Children's Amalgam Trial

This study has been completed.

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00065988
  Purpose

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.


Condition Intervention Phase
Dental Caries
Device: Dispersed phase amalgam restoration /composite restoration
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety Study
Official Title:   Health Effects of Dental Amalgams in Children

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • IQ as measured by the WISC III Test

Estimated Enrollment:   534
Study Start Date:   September 1997
Estimated Study Completion Date:   March 2005

Detailed Description:

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
Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065988

Locations
United States, Massachusetts
New England Research Institute    
      Watertown, Massachusetts, United States, 02472

Sponsors and Collaborators

Investigators
Principal Investigator:     Sonja M McKinlay     New England Research Institutes, Inc    
  More Information


Publications of Results:

Publications indexed to this study:

Study ID Numbers:   NIDCR-11886
First Received:   August 1, 2003
Last Updated:   May 2, 2006
ClinicalTrials.gov Identifier:   NCT00065988
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Tooth Diseases
Stomatognathic Diseases
Dental Caries

Additional relevant MeSH terms:
Tooth Demineralization

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers