Composites and Urinary Bisphenol-A Study

Completed · Not applicable

Conditions studied: Dental Caries

In brief

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.

Key facts

Study ID

NCT01484132

Run by

Carelon Research

People needed

113

Starts

2012-02-01

Expected to finish

2014-06-01

Last updated by the study team

2015-07-10

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 3-16 (<17) years at enrollment.
• 2+ posterior teeth with caries requiring restorations treatable by composite.
• Toilet-trained (not using diapers, pull-ups, or training pants during day or night).

You may not qualify if…

• Medical conditions that would render the subject physically unable to provide urine samples.
• Guardian is not proficient in spoken English or Spanish language
• Child is aged 8.0 years or older and not proficient in spoken English or Spanish language
• Living >35 miles outside of the dental clinic or the NERI office (Watertown MA)

Where it is running

• New England Research Institutes, Inc. — Watertown, Massachusetts, United States

Full record on ClinicalTrials.gov

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