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Caries, DentalPhase 3NCT00066118

Health Effects of Silver-Mercury Dental Fillings

A Phase 3 study testing Dental amalgam restorations in people with Caries, Dental, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Caries, Dental
What is being tested?
Dental amalgam restorations
Type of treatment
Medical device
How many people
507 participants
Where
1 siteUnited States
Study dates
Aug 1996to Feb 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington, School of Dentistry

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: The Casa Pia Study of the Health Effects of Dental Amalgam in Children.

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.

Read the 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

Conditions
Caries, Dental
Being tested
Dental amalgam restorations
Keywords
neurologic, nerve conduction, neurobehavioral, renal disease
Medical subject headings
Dental Caries, Neurologic Manifestations, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental amalgam restorationsDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Memory

  2. Rey Auditory Verbal Learning,

  3. Finger Windows,

  4. Visual Learning

  5. Visual Motor Functions

  6. Drawing, MatchingP

  7. Pegboard sub-tests from the Wide Range Assessment of Visual Motor Abilities.

  8. Attention/Concentration

  9. Coding

  10. Symbol Search

  11. Digit Span

  12. Standard Reaction Time

  13. Stroop

  14. Trails A and B.

  15. Neurological: Nerve Conduction Velocity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2003 (estimated)
  2. Study startAug 1996
  3. Primary completionJul 2005
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
507 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066118
Sponsor's protocol ID
10085
Other IDs
U01DE011894, 95-0401-A 13, NIDCR-11894
Status last verified
May 2018
First submitted
4 Aug 2003
Last updated
4 Jun 2018
Results posted
No

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. doi: 10.1001/jama.295.15.1784.

    PubMed 16622140

  • 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.

    PubMed 17545266

  • 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.

    PubMed 17938746

  • 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.

    PubMed 18245680

  • 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.

    PubMed 18721920

  • 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.

    PubMed 19557617

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dental amalgam restorations in people with Caries, Dental, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Memory. The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066118, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.

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