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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00066118
Other study ID # 10085
Secondary ID U01DE01189495-04
Status Completed
Phase Phase 3
First received
Last updated
Start date August 1996
Est. completion date February 2011

Study information

Verified date May 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The Casa Pia Study of the Health Effects of Dental Amalgam in Children is a randomized, prospective clinical trial with the overall goal of determining if there are detectable health effects due to exposure from mercury-containing dental amalgam fillings. Children, thought to be the population most susceptible to any possible health effects, were randomly assigned to one of two treatment groups (total n=507). Subjects were originally enrolled at ages between 8-10 years of age. To participate, subjects must have: Dental caries in at least one posterior tooth; no prior exposure to dental amalgam; a blood lead of <15ug/L; a urinary mercury level of <10ug/L; an IQ as measured by the CTONI of >67; and no prior or existing serious medical or neurologic condition. One group received only dental filling materials other than those containing mercury (plastic and ceramic composites), while the other group received mercury amalgam fillings where appropriate (in large restorations in back teeth), but the alternative materials everywhere else. Both treatment regimens are standard-of-care throughout the world. Subjects receive ongoing dental care via the study clinics, and continue to receive dental fillings as needed based on group assignment. The target organs of mercury exposure are renal and neurological. Baseline and annual repeated measures are taken on all subjects for renal function, nerve conduction velocity and a large battery of neurobehavioral tests. Follow-up is planned for a period of 7 years


Other known NCT identifiers
  • NCT00000365

Recruitment information / eligibility

Status Completed
Enrollment 507
Est. completion date February 2011
Est. primary completion date July 2005
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dental amalgam restorations


Locations

Country Name City State
United States University of Washington, School of Dentistry Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bernardo M, Luis H, Martin MD, Leroux BG, Rue T, Leitão 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. — View Citation

DeRouen TA, Martin MD, Leroux BG, Townes BD, Woods JS, Leitão 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. — View Citation

Lauterbach M, Martins IP, Castro-Caldas A, Bernardo M, Luis H, Amaral H, Leitão 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 obse — View Citation

Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitão 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 tr — View Citation

Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitão 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 E — View Citation

Woods JS, Martin MD, Leroux BG, DeRouen TA, Leitão 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Memory
Primary Rey Auditory Verbal Learning,
Primary Finger Windows,
Primary Visual Learning
Primary Visual Motor Functions
Primary Drawing, MatchingP
Primary Pegboard sub-tests from the Wide Range Assessment of Visual Motor Abilities.
Primary Attention/Concentration
Primary Coding
Primary Symbol Search
Primary Digit Span
Primary Standard Reaction Time
Primary Stroop
Primary Trails A and B.
Primary Neurological: Nerve Conduction Velocity
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