Status:
COMPLETED
Composites and Urinary Bisphenol-A Study
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Harvard School of Public Health (HSPH)
Conditions:
Dental Caries
Eligibility:
All Genders
3-17 years
Phase:
NA
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 fr...
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. Subject...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01484132
Start Date
February 1 2012
End Date
June 1 2014
Last Update
July 10 2015
Active Locations (1)
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1
New England Research Institutes, Inc.
Watertown, Massachusetts, United States, 02472