Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339339
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
Levels of Bisphenol A in Urine and Saliva Following Placement of Composite Restorations
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Bisphenol A and Metabolites in Urine and Saliva Associated With Placement of Composite Restorations
Status:
COMPLETED
Status Verified Date:
2013-01-22
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:
This study will determine whether placement of composite white dental restorations fillings increases concentrations of bisphenol A BPA and its metabolites in saliva and urine These compounds have estrogenic-like properties that have raised concerns about their safety Small amounts of the chemicals can leach out of dental sealants and be detected in saliva soon after the sealants are applied Dental composites also contain some of these compounds
US Commissioned Corps officers who need fillings as part of their regular dental treatment and who select composite white restorations instead of amalgam metal may be included in this protocol Participants are recruited from among officers receiving dental care at the commissioned officers dental clinic in Rockville Md
Participants complete a 15-minute interview to gather information about their recent diet and eating patterns They also provide 3 to 4 urine and saliva samples some collected before their dental restoration and some after treatment
US Commissioned Corps officers who need fillings as part of their regular dental treatment and who select composite white restorations instead of amalgam metal may be included in this protocol Participants are recruited from among officers receiving dental care at the commissioned officers dental clinic in Rockville Md
Participants complete a 15-minute interview to gather information about their recent diet and eating patterns They also provide 3 to 4 urine and saliva samples some collected before their dental restoration and some after treatment
Detailed Description:
A study by Olea et al in 1996 reported quantities of specific estrogenic compounds Bisphenol A BPA bis-glycidyl methacrylate bis-GMA and Bis-A-dimethacrylate bis-DMA in saliva associated with the placement of certain dental sealants This report raised concern regarding the safety of dental sealants and composite restorations In a subsequent study bis-GMA was found to be stable but bis-DMA was shown to hydrolyze to BPA which likely accounts for the BPA detected in extracts from certain sealants Another study reported detectable amounts of triethylene glycol dimethacrylate TEGDMA and BPA diglycidyl ether BADGE were released from sealants into saliva All of these compounds have been shown to have deleterious effects for specific endpoints in vitro and various endocrine disruptive effects in some animal models although results have not been consistent across animal strain mode of administration diet and other unknown factors Detectable levels in plasma have not been shown
Since there are insufficient data on the leachability concentrations in body fluids of these compounds associated with composite fillings in humans it is important to determine whether or not there are detectable levels of these compounds associated with the placement of composite restorations and if so whether the levels are sufficiently below the maximum acceptable or reference dose established by the EPA For bisphenol A the maximum acceptable dose is 005 milligrams per kilogram of body weight per day US EPA 1993
The National Institute of Dental and Craniofacial Research the National Toxicology Program of the National Institute of Environmental Health Sciences and the Commissioned Officers Dental Clinic Dentists have a unique opportunity to conduct a collaborative investigation at the Commissioned Officers Dental Clinic CODC in Rockville MD involving commissioned officers who need dental restorations This study will determine whether or not the placement of composite restorations is associated with the presence of these compounds in saliva This is particularly timely since the number of composite restorations placed by dentists practicing in the US is rapidly increasing with over 80 million composite restorations placed in 1999 ADA 2001 It is of relevance to the US Public Health Service Commissioned Officers Dental Clinic CODC because the CODC places composite materials in its dental clinic and wants to ensure that commissioned officers are receiving the best and safest possible dental care
Since there are insufficient data on the leachability concentrations in body fluids of these compounds associated with composite fillings in humans it is important to determine whether or not there are detectable levels of these compounds associated with the placement of composite restorations and if so whether the levels are sufficiently below the maximum acceptable or reference dose established by the EPA For bisphenol A the maximum acceptable dose is 005 milligrams per kilogram of body weight per day US EPA 1993
The National Institute of Dental and Craniofacial Research the National Toxicology Program of the National Institute of Environmental Health Sciences and the Commissioned Officers Dental Clinic Dentists have a unique opportunity to conduct a collaborative investigation at the Commissioned Officers Dental Clinic CODC in Rockville MD involving commissioned officers who need dental restorations This study will determine whether or not the placement of composite restorations is associated with the presence of these compounds in saliva This is particularly timely since the number of composite restorations placed by dentists practicing in the US is rapidly increasing with over 80 million composite restorations placed in 1999 ADA 2001 It is of relevance to the US Public Health Service Commissioned Officers Dental Clinic CODC because the CODC places composite materials in its dental clinic and wants to ensure that commissioned officers are receiving the best and safest possible dental care
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 |
|---|---|---|---|
| 04-D-N253 | None | None | None |