Levels of Bisphenol A in Urine and Saliva Following Placement of Composite Restorations

December 14, 2019 updated by: National Institute of Dental and Craniofacial Research (NIDCR)

Bisphenol A and Metabolites in Urine and Saliva Associated With Placement of Composite Restorations

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.

U.S. 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.

Study Overview

Status

Completed

Conditions

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 0.05 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 U.S is rapidly increasing with over 80 million composite restorations placed in 1999 (ADA, 2001). It is of relevance to the U.S. 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 Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States
        • Commissioned Officers Dental Clinic (CODC)
    • Mississippi
      • Biloxi, Mississippi, United States, 39534-2519
        • Kessler Air Force Base Dental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Individual patients who require at least one restoration are eligible. We will give preference to patients who require multiple restorations that qualify for a composite filling material. Every attempt will be made to adequately represent women and minorities into the study.

EXCLUSION CRITERIA:

Individual patients who have received composite restorations or pit and fissure sealants during the past 3 months and individuals who wear removable dental appliances, such as orthodontic retainers or partial dentures, will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Albert Kingman, Ph.D., National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 26, 2004

Primary Completion

December 7, 2022

Study Completion

January 22, 2013

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 14, 2019

Last Verified

January 22, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 999904253
  • 04-D-N253

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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