Composites and Urinary Bisphenol-A Study (CUBS)

Carelon Research

Status

Completed

Conditions

Dental Caries

Treatments

Procedure: Restoration of dental caries with dental composite

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01484132

1R01ES019155

Details and patient eligibility

About

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.

Full description

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.

Enrollment

113 patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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)