Composites and Urinary Bisphenol-A Study

NCT ID: NCT01484132

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-06-30

Brief 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.

Detailed 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.

Conditions

Dental Caries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Composite

Group Type: EXPERIMENTAL

Restoration of dental caries with dental composite

Intervention Type: PROCEDURE

Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

Interventions

Restoration of dental caries with dental composite

Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

Intervention Type: PROCEDURE

Other Intervention Names

Composite to be used is Z100 by 3M ESPE (St Paul, MN, USA).

Eligibility Criteria

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonja McKinlay, PhD

Role: PRINCIPAL_INVESTIGATOR

Carelon Research

Locations

New England Research Institutes, Inc.

Watertown, Massachusetts, United States

Countries

United States

Other Identifiers

1R01ES019155

Identifier Type: NIH

Identifier Source: org_study_id

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