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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00339339
First received: June 19, 2006
Last updated: August 20, 2013
Last verified: January 2013
  Purpose

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.


Condition
Dental Restorations

Study Type: Observational
Official Title: Bisphenol A and Metabolites in Urine and Saliva Associated With Placement of Composite Restorations

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 76
Study Start Date: July 2004
Estimated Study Completion Date: January 2013
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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339339

Locations
United States, Maryland
Commissioned Officers Dental Clinic (CODC)
Rockville, Maryland, United States
United States, Mississippi
Kessler Air Force Base Dental Clinic
Biloxi, Mississippi, United States, 39534-2519
Sponsors and Collaborators
Investigators
Principal Investigator: Albert Kingman, Ph.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

No publications provided by National Institutes of Health Clinical Center (CC)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00339339     History of Changes
Other Study ID Numbers: 999904253, 04-D-N253
Study First Received: June 19, 2006
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Dental Materials
Resins
BisDMA
Absorption
Systemic

Additional relevant MeSH terms:
Bisphenol A
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014