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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 |
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 |
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 |
Estimated Enrollment: | 534 |
Study Start Date: | September 1997 |
Estimated Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 6 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, Massachusetts | |||||
New England Research Institute | |||||
Watertown, Massachusetts, United States, 02472 |
Principal Investigator: | Sonja M McKinlay | New England Research Institutes, Inc |
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 |
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