Health Effects of Silver-Mercury Dental Fillings - Full Text View

Sponsor:	University of Washington
Collaborator:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	University of Washington
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:	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:

MedlinePlus related topics: Mercury Tooth Decay

U.S. FDA Resources

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

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

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:

DeRouen TA, Martin MD, Leroux BG, Townes BD, Woods JS, Leitao J, Castro-Caldas A, Luis H, Bernardo M, Rosenbaum G, Martins IP. Neurobehavioral effects of dental amalgam in children: a randomized clinical trial. JAMA. 2006 Apr 19;295(15):1784-92.

Bernardo M, Luis H, Martin MD, Leroux BG, Rue T, Leitão J, DeRouen TA. Survival and reasons for failure of amalgam versus composite posterior restorations placed in a randomized clinical trial. J Am Dent Assoc. 2007 Jun;138(6):775-83.

Woods JS, Martin MD, Leroux BG, DeRouen TA, Leitão JG, Bernardo MF, Luis HS, Simmonds PL, Kushleika JV, Huang Y. The contribution of dental amalgam to urinary mercury excretion in children. Environ Health Perspect. 2007 Oct;115(10):1527-31.

Lauterbach M, Martins IP, Castro-Caldas A, Bernardo M, Luis H, Amaral H, Leitão J, Martin MD, Townes B, Rosenbaum G, Woods JS, Derouen T. Neurological outcomes in children with and without amalgam-related mercury exposure: seven years of longitudinal observations in a randomized trial. J Am Dent Assoc. 2008 Feb;139(2):138-45. Erratum in: J Am Dent Assoc. 2008 Apr;139(4):404.

Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitão JG, Kushleika JV, Rue TC, Korpak AM. Biomarkers of kidney integrity in children and adolescents with dental amalgam mercury exposure: findings from the Casa Pia children's amalgam trial. Environ Res. 2008 Nov;108(3):393-9. Epub 2008 Aug 21.

Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitão JG, Simmonds PL, Echeverria D, Rue TC. Urinary porphyrin excretion in children with mercury amalgam treatment: findings from the Casa Pia Children's Dental Amalgam Trial. J Toxicol Environ Health A. 2009;72(14):891-6.

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 February 09, 2012