Composites and Urinary Bisphenol-A Study (CUBS)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

National Institute of Environmental Health Sciences (NIEHS)

Harvard School of Public Health

Information provided by (Responsible Party):

New England Research Institutes

ClinicalTrials.gov Identifier:

NCT01484132

First received: November 16, 2011

Last updated: February 25, 2014

Last verified: February 2014

History of Changes

Purpose

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.

Condition	Intervention
Dental Caries	Procedure: Restoration of dental caries with dental composite


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay

U.S. FDA Resources

Further study details as provided by New England Research Institutes:

Primary Outcome Measures:

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 ]


Estimated Enrollment:	139
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)

Arms	Assigned Interventions
Experimental: Composite	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).

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.

Eligibility


Ages Eligible for Study:	3 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484132

Locations


United States, Massachusetts
New England Research Institutes, Inc.
Watertown, Massachusetts, United States, 02472

Sponsors and Collaborators

New England Research Institutes

National Institute of Environmental Health Sciences (NIEHS)

Harvard School of Public Health

Investigators


Principal Investigator:	Sonja McKinlay, PhD	New England Research Institutes

More Information

No publications provided


Responsible Party:	New England Research Institutes
ClinicalTrials.gov Identifier:	NCT01484132 History of Changes
Other Study ID Numbers:	1R01ES019155
Study First Received:	November 16, 2011
Last Updated:	February 25, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by New England Research Institutes:


Dental Caries Dental Restorative Materials Dental Composite Bisphenol-A

Additional relevant MeSH terms:


Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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