Levels of Bisphenol A in Urine and Saliva Following Placement of Composite Restorations
Bisphenol A and Metabolites in Urine and Saliva Associated With Placement of Composite Restorations
2 other identifiers
observational
172
1 country
2
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2004
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2004
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2013
CompletedDecember 17, 2019
January 22, 2013
June 19, 2006
December 14, 2019
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Commissioned Officers Dental Clinic (CODC)
Rockville, Maryland, United States
Kessler Air Force Base Dental Clinic
Biloxi, Mississippi, 39534-2519, United States
Related Publications (1)
Kingman A, Hyman J, Masten SA, Jayaram B, Smith C, Eichmiller F, Arnold MC, Wong PA, Schaeffer JM, Solanki S, Dunn WJ. Bisphenol A and other compounds in human saliva and urine associated with the placement of composite restorations. J Am Dent Assoc. 2012 Dec;143(12):1292-302. doi: 10.14219/jada.archive.2012.0090.
PMID: 23204083DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Kingman, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
July 26, 2004
Study Completion
January 22, 2013
Last Updated
December 17, 2019
Record last verified: 2013-01-22