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Health Effects of Silver-Mercury Dental Fillings
This study has been completed.
First Received: August 4, 2003   Last Updated: May 2, 2006   History of Changes
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00066118
  Purpose

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.


Condition Intervention Phase
Caries, Dental
Device: Dental amalgam restorations
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study
Official Title: The Casa Pia Study of the Health Effects of Dental Amalgam in Children.

Resource links provided by NLM:


Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 507
Study Start Date: August 1996
Estimated Study Completion Date: July 2005
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

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066118

Locations
United States, Washington
University of Washington, School of Dentistry
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Investigators
Principal Investigator: Timothy DeRouen University of Washington
Study Chair: Michael Martin University of Washington
  More Information

Publications:
Study ID Numbers: NIDCR-11894
Study First Received: August 4, 2003
Last Updated: May 2, 2006
ClinicalTrials.gov Identifier: NCT00066118     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
neurologic
nerve conduction
neurobehavioral
renal disease

Study placed in the following topic categories:
Tooth Diseases
Stomatognathic Diseases
Kidney Diseases
Dental Caries

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on July 02, 2009