ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Health Effects of Silver-Mercury Dental Fillings

This study has been completed.

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

MedlinePlus related topics:   Mercury   

U.S. FDA Resources

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.

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 of Results:

Study ID Numbers:   NIDCR-11894
First Received:   August 4, 2003
Last Updated:   May 2, 2006
ClinicalTrials.gov Identifier:   NCT00066118
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 Demineralization

ClinicalTrials.gov processed this record on August 19, 2008




Links to all studies - primarily for crawlers