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NCT01484132 · ClinicalTrials.gov registry record · NA
Composites and Urinary Bisphenol-A Study
A NA study, sponsored by Carelon Research.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT01484132: Completed NA study, sponsored by Carelon Research.
NCT01484132 is a NA study that has completed, run by Carelon Research. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484132, a NA study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
Study 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.
Primary Outcome
BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA \* \[(meanSG - 1)/(SG - 1)\], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at follow-up minus BPA at baseline. Analysis of change in BPA was done using the arithmetic mean.
Interventions
- PROCEDURE Restoration of dental caries with dental composite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-06 |
| Phase | NA |
What the finished NCT01484132 record still lists
NCT01484132 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Restoration of dental caries with dental composite is the first listed.
NCT01484132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01484132 about?
NCT01484132 is a clinical study titled "Composites and Urinary Bisphenol-A Study". 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 ...
What is the current status of trial NCT01484132?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2012-02. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01484132?
The interventions under investigation include: Restoration of dental caries with dental composite (PROCEDURE).
Who is sponsoring clinical trial NCT01484132?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01484132's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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