Caries, Dental Clinical Trial
Official title:
The Casa Pia Study of the Health Effects of Dental Amalgam in Children.
Verified date | May 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington, School of Dentistry | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
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
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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