We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Health Effects of Silver-Mercury Dental Fillings

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00066118
First Posted: August 5, 2003
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Timothy DeRouen, University of Washington
  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
Intervention Model: Parallel Assignment
Masking: Single
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 Timothy DeRouen, 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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066118


Locations
United States, Washington
University of Washington, School of Dentistry
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Timothy DeRouen University of Washington
Study Chair: Michael Martin University of Washington
  More Information

Publications:

Responsible Party: Timothy DeRouen, Professor Emeritus of Oral Health Sciences, School of Dentistry, University of Washington
ClinicalTrials.gov Identifier: NCT00066118     History of Changes
Obsolete Identifiers: NCT00000365
Other Study ID Numbers: 10085-A
U01DE011894 ( U.S. NIH Grant/Contract )
95-0401-A 13 ( Other Identifier: UW Human Subjects Division )
NIDCR-11894
First Submitted: August 4, 2003
First Posted: August 5, 2003
Last Update Posted: March 22, 2017
Last Verified: March 2017

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

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