The Children's Amalgam Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00065988
First received: August 1, 2003
Last updated: April 27, 2010
Last verified: August 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Health Effects of Dental Amalgams in Children

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00065988     History of Changes
Obsolete Identifiers: NCT00000364
Other Study ID Numbers: NIDCR-11886, U01DE011886
Study First Received: August 1, 2003
Last Updated: April 27, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 17, 2014