N/A
Completed N=113
Composites and Urinary Bisphenol-A Study
Source: ClinicalTrials.gov NCT01484132 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months — 0.29 ng/mL — p=0.58
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months |
0.29 | 0.58 |
| PRIMARY Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment |
1.71 | 0.11 |
| PRIMARY Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment |
-0.50 | 0.27 |
| PRIMARY Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment |
-0.59 | 0.41 |
| PRIMARY Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment |
-0.28 | 0.76 |
Eligibility Criteria
Inclusion Criteria
- Aged 3-16 ( 35 miles outside of the dental clinic or the NERI office (Watertown MA)
Data sourced from ClinicalTrials.gov (NCT01484132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.