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The Children's Amalgam Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065988
First Posted: August 5, 2003
Last Update Posted: April 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
New England Research Institutes
  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
Intervention Model: Single Group Assignment
Masking: Single
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065988


Locations
United States, Massachusetts
New England Research Institute
Watertown, Massachusetts, United States, 02472
Sponsors and Collaborators
New England Research Institutes
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Sonja M McKinlay New England Research Institutes, Inc
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Trachtenberg FL, Shrader P, Barregard L, Maserejian NN. Dental composite materials and renal function in children. Br Dent J. 2014 Jan;216(2):E4. doi: 10.1038/sj.bdj.2014.36.
Maserejian NN, Hauser R, Tavares M, Trachtenberg FL, Shrader P, McKinlay S. Dental composites and amalgam and physical development in children. J Dent Res. 2012 Nov;91(11):1019-25. doi: 10.1177/0022034512458691. Epub 2012 Sep 12.
Maserejian NN, Trachtenberg FL, Hauser R, McKinlay S, Shrader P, Bellinger DC. Dental composite restorations and neuropsychological development in children: treatment level analysis from a randomized clinical trial. Neurotoxicology. 2012 Oct;33(5):1291-7. doi: 10.1016/j.neuro.2012.08.001. Epub 2012 Aug 14.
Maserejian NN, Trachtenberg FL, Hauser R, McKinlay S, Shrader P, Tavares M, Bellinger DC. Dental composite restorations and psychosocial function in children. Pediatrics. 2012 Aug;130(2):e328-38. doi: 10.1542/peds.2011-3374. Epub 2012 Jul 16.
Trachtenberg F, Barregard L. Effect of storage time at -20°C on markers used for assessment of renal damage in children: albumin, γ-glutamyl transpeptidase, N-acetyl-β-D-glucosaminidase and α1-microglobulin. Scand J Urol Nephrol. 2010 Nov;44(5):331-6. doi: 10.3109/00365599.2010.492785. Epub 2010 Jun 21.
Trachtenberg F, Maserejian NN, Soncini JA, Hayes C, Tavares M. Does fluoride in compomers prevent future caries in children? J Dent Res. 2009 Mar;88(3):276-9. doi: 10.1177/0022034508330884.
Maserejian NN, Trachtenberg F, Link C, Tavares M. Underutilization of dental care when it is freely available: a prospective study of the New England Children's Amalgam Trial. J Public Health Dent. 2008 Summer;68(3):139-48. doi: 10.1111/j.1752-7325.2007.00074.x.
Soncini JA, Maserejian NN, Trachtenberg F, Tavares M, Hayes C. The longevity of amalgam versus compomer/composite restorations in posterior primary and permanent teeth: findings From the New England Children's Amalgam Trial. J Am Dent Assoc. 2007 Jun;138(6):763-72.

ClinicalTrials.gov Identifier: NCT00065988     History of Changes
Obsolete Identifiers: NCT00000364
Other Study ID Numbers: NIDCR-11886
U01DE011886 ( U.S. NIH Grant/Contract )
First Submitted: August 1, 2003
First Posted: August 5, 2003
Last Update Posted: April 28, 2010
Last Verified: August 2005

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


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