Health Effects of Silver-Mercury Dental Fillings
Primary Purpose
Caries, Dental
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dental amalgam restorations
Sponsored by
About this trial
This is an interventional treatment trial for Caries, Dental focused on measuring neurologic, nerve conduction, neurobehavioral, renal disease
Eligibility 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
Sites / Locations
- University of Washington, School of Dentistry
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00066118
First Posted
August 4, 2003
Last Updated
May 31, 2018
Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT00066118
Brief Title
Health Effects of Silver-Mercury Dental Fillings
Official Title
The Casa Pia Study of the Health Effects of Dental Amalgam in Children.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
neurologic, nerve conduction, neurobehavioral, renal disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
507 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Dental amalgam restorations
Primary Outcome Measure Information:
Title
Memory
Title
Rey Auditory Verbal Learning,
Title
Finger Windows,
Title
Visual Learning
Title
Visual Motor Functions
Title
Drawing, MatchingP
Title
Pegboard sub-tests from the Wide Range Assessment of Visual Motor Abilities.
Title
Attention/Concentration
Title
Coding
Title
Symbol Search
Title
Digit Span
Title
Standard Reaction Time
Title
Stroop
Title
Trails A and B.
Title
Neurological: Nerve Conduction Velocity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy DeRouen
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Martin
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
University of Washington, School of Dentistry
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16622140
Citation
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. doi: 10.1001/jama.295.15.1784.
Results Reference
result
PubMed Identifier
17545266
Citation
Bernardo M, Luis H, Martin MD, Leroux BG, Rue T, Leitao 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. doi: 10.14219/jada.archive.2007.0265.
Results Reference
result
PubMed Identifier
17938746
Citation
Woods JS, Martin MD, Leroux BG, DeRouen TA, Leitao 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. doi: 10.1289/ehp.10249.
Results Reference
result
PubMed Identifier
18245680
Citation
Lauterbach M, Martins IP, Castro-Caldas A, Bernardo M, Luis H, Amaral H, Leitao 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. doi: 10.14219/jada.archive.2008.0128. Erratum In: J Am Dent Assoc. 2008 Apr;139(4):404.
Results Reference
result
PubMed Identifier
18721920
Citation
Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitao 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. doi: 10.1016/j.envres.2008.07.003. Epub 2008 Aug 21.
Results Reference
result
PubMed Identifier
19557617
Citation
Woods JS, Martin MD, Leroux BG, DeRouen TA, Bernardo MF, Luis HS, Leitao 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. doi: 10.1080/15287390902959557.
Results Reference
result
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Health Effects of Silver-Mercury Dental Fillings
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