NCT00065988

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

April 28, 2010

Status Verified

August 1, 2005

First QC Date

August 1, 2003

Last Update Submit

April 27, 2010

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • IQ as measured by the WISC III Test

Interventions

Dispersed phase amalgam restoration /composite restorationDEVICE

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

New England Research Institute

Watertown, Massachusetts, 02472, United States

Location

Related Publications (9)

  • 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.

    PMID: 16622139RESULT

  • 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.

    PMID: 24457893DERIVED

  • 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.

    PMID: 22972857DERIVED

  • 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.

    PMID: 22906860DERIVED

  • 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.

    PMID: 22802599DERIVED

  • 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.

    PMID: 20560801DERIVED

  • 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.

    PMID: 19329464DERIVED

  • 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.

    PMID: 18248343DERIVED

  • 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.

    PMID: 17545265DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sonja M McKinlay

    New England Research Institutes, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

September 1, 1997

Study Completion

March 1, 2005

Last Updated

April 28, 2010

Record last verified: 2005-08

Locations

US(1)