Health Effects of Silver-Mercury Dental Fillings

Caries, Dental Clinical Trial

Official title:

The Casa Pia Study of the Health Effects of Dental Amalgam in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066118
• Other study ID #: 10085
• Secondary ID: U01DE01189495-04
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

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