The Children's Amalgam Trial

Dental Caries Clinical Trial

Official title:

Health Effects of Dental Amalgams in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065988
• Other study ID #: NIDCR-11886
• Secondary ID: U01DE011886
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2003
• Last updated: April 27, 2010
• Start date: September 1997
• Est. completion date: March 2005

Study information

• Verified date: August 2005
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00000364

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Dispersed phase amalgam restoration /composite restoration

Locations

Country	Name	City	State
United States	New England Research Institute	Watertown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
New England Research Institutes	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bellinger DC, Trachtenberg F, Barregard L, Tavares M, Cernichiari E, Daniel D, McKinlay S. Neuropsychological and renal effects of dental amalgam in children: a randomized clinical trial. JAMA. 2006 Apr 19;295(15):1775-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IQ as measured by the WISC III Test