Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065988
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2003-08-01
Brief Title:
The Childrens Amalgam Trial
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Health Effects of Dental Amalgams in Children
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Childrens Amalgam Trial is one of only two randomized trials of its kind and the only such trial in the United States to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children
Detailed Description:
The safety of silver amalgam as a dental restorative material has been controversial since its introduction 150 years ago but until recently it has been assumed that the exposure to mercury from dental amalgam is limited to the acute placement phase However some recent studies have raised safety concerns by demonstrating chronic release of mercury vapor from amalgam fillings during chewing and brushing The Childrens Amalgam Trial CAT is a two-arm randomized trial of safety comparing amalgam with a mercury-free restorative material A single masking procedure is used to ensure that all investigators and staff measuring outcomes are unaware of assigned trial arm The study follows 534 New England children aged 6-10 years at enrollment for 5 years The children were recruited from two northeastern US communities one in rural Maine and one in urban Massachusetts No trial subjects received prior amalgam restorations and all were in need of at least two posterior occlusal fillings Participants were randomized to receive either amalgam or composite material for all posterior restorations at baseline and at subsequent visits The primary endpoint will be 5-year change in IQ scores Secondary endpoints will include measures of other neuropsychological assessments and renal functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DE011886 | NIH | None | httpsreporternihgovquickSearchU01DE011886 |