NCT00066118

Brief Summary

The purpose of this study is to determine whether there are detectable health effects of low-level mercury exposure (from normal exposure to mercury-containing dental fillings) in the known target organs/systems affected by elemental mercury exposure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
507

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 1996

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

August 1, 1996

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

8.9 years

First QC Date

August 4, 2003

Last Update Submit

May 31, 2018

Conditions

Caries, Dental

Keywords

neurologicnerve conductionneurobehavioralrenal disease

Outcome Measures

Primary Outcomes (15)

  • Memory

  • Rey Auditory Verbal Learning,

  • Finger Windows,

  • Visual Learning

  • Visual Motor Functions

  • Drawing, MatchingP

  • Pegboard sub-tests from the Wide Range Assessment of Visual Motor Abilities.

  • Attention/Concentration

  • Coding

  • Symbol Search

  • Digit Span

  • Standard Reaction Time

  • Stroop

  • Trails A and B.

  • Neurological: Nerve Conduction Velocity

Interventions

Dental amalgam restorationsDEVICE

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Age 8-10 years of age * Dental caries in at least one posterior tooth. * No prior exposure to dental amalgam * Blood lead of \<15ug/L * Urinary mercury level of \<10ug/L * IQ as measured by the CTONI of \>67 * No prior or existing serious medical or neurologic condition

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

Sponsors & Collaborators

Study Sites (1)

University of Washington, School of Dentistry

Seattle, Washington, 98195, United States

Location

Related Publications (6)

  • DeRouen TA, Martin MD, Leroux BG, Townes BD, Woods JS, Leitao J, Castro-Caldas A, Luis H, Bernardo M, Rosenbaum G, Martins IP. Neurobehavioral effects of dental amalgam in children: a randomized clinical trial. JAMA. 2006 Apr 19;295(15):1784-92. doi: 10.1001/jama.295.15.1784.

    PMID: 16622140RESULT

  • Bernardo M, Luis H, Martin MD, Leroux BG, Rue T, Leitao J, DeRouen TA. Survival and reasons for failure of amalgam versus composite posterior restorations placed in a randomized clinical trial. J Am Dent Assoc. 2007 Jun;138(6):775-83. doi: 10.14219/jada.archive.2007.0265.

    PMID: 17545266RESULT

  • Woods JS, Martin MD, Leroux BG, DeRouen TA, Leitao JG, Bernardo MF, Luis HS, Simmonds PL, Kushleika JV, Huang Y. The contribution of dental amalgam to urinary mercury excretion in children. Environ Health Perspect. 2007 Oct;115(10):1527-31. doi: 10.1289/ehp.10249.

    PMID: 17938746RESULT

  • Lauterbach M, Martins IP, Castro-Caldas A, Bernardo M, Luis H, Amaral H, Leitao J, Martin MD, Townes B, Rosenbaum G, Woods JS, Derouen T. Neurological outcomes in children with and without amalgam-related mercury exposure: seven years of longitudinal observations in a randomized trial. J Am Dent Assoc. 2008 Feb;139(2):138-45. doi: 10.14219/jada.archive.2008.0128.

    PMID: 18245680RESULT

  • Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitao JG, Kushleika JV, Rue TC, Korpak AM. Biomarkers of kidney integrity in children and adolescents with dental amalgam mercury exposure: findings from the Casa Pia children's amalgam trial. Environ Res. 2008 Nov;108(3):393-9. doi: 10.1016/j.envres.2008.07.003. Epub 2008 Aug 21.

    PMID: 18721920RESULT

  • Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitao JG, Simmonds PL, Echeverria D, Rue TC. Urinary porphyrin excretion in children with mercury amalgam treatment: findings from the Casa Pia Children's Dental Amalgam Trial. J Toxicol Environ Health A. 2009;72(14):891-6. doi: 10.1080/15287390902959557.

    PMID: 19557617RESULT

MeSH Terms

Conditions

Dental CariesNeurologic ManifestationsKidney Diseases

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Timothy DeRouen

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Michael Martin

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus of Oral Health Sciences, School of Dentistry

Study Record Dates

First Submitted

August 4, 2003

First Posted

August 5, 2003

Study Start

August 1, 1996

Primary Completion

July 1, 2005

Study Completion

February 1, 2011

Last Updated

June 4, 2018

Record last verified: 2018-05

Locations

US(1)