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Completed

NCT Number: NCT00066118

Health Effects of Silver-Mercury Dental Fillings

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.

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Key information

Conditions

Caries, Dental Dental Caries Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases Urogenital Diseases Urologic Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Washington, School of Dentistry

Seattle, Washington, 98195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Dental amalgam restorations

Device

Primary outcomes

  1. Memory

  2. Rey Auditory Verbal Learning,

  3. Finger Windows,

  4. Visual Learning

  5. Visual Motor Functions

  6. Drawing, MatchingP

  7. Pegboard sub-tests from the Wide Range Assessment of Visual Motor Abilities.

  8. Attention/Concentration

  9. Coding

  10. Symbol Search

  11. Digit Span

  12. Standard Reaction Time

  13. Stroop

  14. Trails A and B.

  15. Neurological: Nerve Conduction Velocity

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
2005
Study completion
2011
First posted
Aug 5, 2003
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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