Composites and Urinary Bisphenol-A Study (CUBS)
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 Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Health Effects of Dental Composites in Children|
- Change from baseline in urinary bisphenol A level and 1 day [ Time Frame: Baseline and 1 day ] [ Designated as safety issue: No ]
- Change from baseline in urinary bisphenol A level and 14 days [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
- Change from baseline in urinary bisphenol A level and 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Procedure: Restoration of dental caries with dental composite
Dental Resin Restoration (bisphenol A diglycidylether methacrylate based composite)
Other Name: Composite to be used is Z100 by 3M ESPE (St Paul, MN, USA).
Study subjects will be new or existing patients of the clinical sites who are in need of dental restorations, meet all eligibility criteria, and provide informed consent/assent to participate. Subjects will be asked to provide two pre-treatment urine samples and three post-treatment samples. Urine collections occur next-day and 14 days after treatment, with one final urine collected approximately 6 months later (marking the end of the subject's active study participation). Data will be collected from the clinician's standard oral examination (including new and existing dental treatments), the data collector's measurements of height and weight and interviews administered to the parents/guardians to assess sociodemographic and other relevant factors (e.g., recent food/beverage consumption). Confidentiality will be maintained by assigning each subject a unique number and using only this number or aggregate data in all study reports. All study records will be securely maintained with access limited to essential study personnel only.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484132
|United States, Massachusetts|
|New England Research Institutes, Inc.|
|Watertown, Massachusetts, United States, 02472|
|Principal Investigator:||Sonja McKinlay, PhD||New England Research Institutes|