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Health Effects of Silver-Mercury Dental Fillings

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00066118
Enrollment
507
Registered
2003-08-05
Start date
1996-08-31
Completion date
2011-02-28
Last updated
2018-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Dental

Keywords

neurologic, nerve conduction, neurobehavioral, renal disease

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.

Detailed 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

Interventions

DEVICEDental amalgam restorations

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026