- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065988
The Children's Amalgam Trial
April 27, 2010 updated by: HealthCore-NERI
Health Effects of Dental Amalgams in Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
534
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Watertown, Massachusetts, United States, 02472
- New England Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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IQ as measured by the WISC III Test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sonja M McKinlay, New England Research Institutes, Inc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1001/jama.295.15.1775.
- 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 degrees C on markers used for assessment of renal damage in children: albumin, gamma-glutamyl transpeptidase, N-acetyl-beta-D-glucosaminidase and alpha1-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. doi: 10.14219/jada.archive.2007.0264.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1997
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
August 1, 2003
First Submitted That Met QC Criteria
August 4, 2003
First Posted (Estimate)
August 5, 2003
Study Record Updates
Last Update Posted (Estimate)
April 28, 2010
Last Update Submitted That Met QC Criteria
April 27, 2010
Last Verified
August 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDCR-11886
- U01DE011886 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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