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Composites and Urinary Bisphenol-A Study

NCT01484132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2015-07-10

Study results available
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Summary

The Composites and Urinary Bisphenol-A Study (CUBS) is a clinical study of dental composite for its effects on urinary bisphenol-A levels. The study will enroll approximately 139 children recruited from study-affiliated clinical sites in New England.The primary aim of CUBS is to test the hypothesis that urinary bisphenol-A (BPA) concentrations increase after composite restoration placement. BPA is a chemical used in the synthesis of matrix monomers and has been shown to have harmful effects in toxicological studies in laboratory animals. Currently it is unknown whether dental composite restorative materials containing monomers that are derived from BPA result in chronic low-dose BPA exposure in children.

Conditions

  • Dental Caries

Interventions

PROCEDURE

Restoration of dental caries with dental composite

Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • Sonja McKinlay, PhD · Carelon Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484132 on ClinicalTrials.gov