Health Effects of Silver-Mercury Dental Fillings

NCT ID: NCT00066118

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-08-31
• Study Completion Date: 2011-02-28

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

Conditions

Caries, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Dental amalgam restorations

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Timothy DeRouen

Professor Emeritus of Oral Health Sciences, School of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy DeRouen

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Michael Martin

Role: STUDY_CHAIR

University of Washington

Locations

University of Washington, School of Dentistry

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16622140 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17545266 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17938746 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18245680 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18721920 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19557617 (View on PubMed)

Other Identifiers

U01DE011894

Identifier Type: NIH

Identifier Source: secondary_id

View Link

95-0401-A 13

Identifier Type: OTHER

Identifier Source: secondary_id

NIDCR-11894

Identifier Type: OTHER

Identifier Source: secondary_id

10085

Identifier Type: -

Identifier Source: org_study_id

NCT00000365

Identifier Type: -

Identifier Source: nct_alias