Composites and Urinary Bisphenol-A Study
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | June 2014 |
Health Effects of Dental Composites in Children
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.
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 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.
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.
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)
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