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Dental CariesPhase 3NCT00065988

The Children's Amalgam Trial

A Phase 3 study testing Dispersed phase amalgam restoration /composite restoration in people with Dental Caries, run by Carelon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 10 years
Conditions the study is for
Dental Caries
What is being tested?
Dispersed phase amalgam restoration /composite restoration
Type of treatment
Medical device
How many people
534 participants
Where
1 siteUnited States
Study dates
Sep 1997to Mar 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 10 years
  • All sexes
  • No healthy volunteers
  • Child
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New England Research Institute

    Watertown, Massachusetts, 02472

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Dental Caries
Being tested
Dispersed phase amalgam restoration /composite restoration
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dispersed phase amalgam restoration /composite restorationDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IQ as measured by the WISC III Test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2003 (estimated)
  2. Study startSep 1997
  3. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
534 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00065988
Sponsor's protocol ID
NIDCR-11886
Other IDs
U01DE011886
Status last verified
Aug 2005
First submitted
1 Aug 2003
Last updated
28 Apr 2010
Results posted
No

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.

    PubMed 16622139

  • 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.

    PubMed 24457893

  • 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.

    PubMed 22972857

  • 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.

    PubMed 22906860

  • 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.

    PubMed 22802599

  • 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.

    PubMed 20560801

  • 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.

    PubMed 19329464

  • 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.

    PubMed 18248343

  • 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.

    PubMed 17545265

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dispersed phase amalgam restoration /composite restoration in people with Dental Caries, run by Carelon Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IQ as measured by the WISC III Test. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065988, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2010.

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