Overview

This trial is active, not recruiting.

Condition caries, dental
Treatment dental amalgam restorations
Phase phase 3
Sponsor University of Washington
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date August 1996
End date July 2005
Trial size 507 participants
Trial identifier NCT00066118, 10085-A, 95-0401-A 13, NCT00000365, NIDCR-11894, U01DE011894

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 8 years up to 12 years old.

- 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

Additional Information

Official title The Casa Pia Study of the Health Effects of Dental Amalgam in Children.
Principal investigator Timothy DeRouen
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by University of Washington.