Health Effects of Silver-Mercury Dental Fillings

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00066118
First received: August 4, 2003
Last updated: September 2, 2010
Last verified: September 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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 University of Washington:

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: February 2011
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Washington
Investigators
Principal Investigator: Timothy DeRouen University of Washington
Study Chair: Michael Martin University of Washington
  More Information

Publications:

Responsible Party: DeRouen, Timothy Ph.D., University of Washington
ClinicalTrials.gov Identifier: NCT00066118     History of Changes
Obsolete Identifiers: NCT00000365
Other Study ID Numbers: 10085-A, U01DE011894, 95-0401-A 13, NIDCR-11894
Study First Received: August 4, 2003
Last Updated: September 2, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
neurologic
nerve conduction
neurobehavioral
renal disease

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

ClinicalTrials.gov processed this record on August 28, 2014