CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Restoration of dental caries with dental compositeprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01484132
NCT01484132N/ACompleted
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Health Effects of Dental Composites in Children

Carelon Research·interventional·Posted Dec 2, 2011·Updated Jul 10, 2015

In Brief

A clinical study evaluating Restoration of dental caries with dental composite for Dental Caries. Completed, enrolled 113 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
CollaboratorsNational Institute of Environmental Health Sciences (NIEHS), Harvard School of Public Health (HSPH)

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2011
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

Restoration of dental caries with dental compositeprocedure

Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)