Composites and Urinary Bisphenol-A Study - Full Text View

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 in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months [ Time Frame: From Baseline to 6 months ] [ Designated as safety issue: Yes ]
BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at follow-up minus BPA at baseline. Analysis of change in BPA was done using the arithmetic mean.
Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment [ Time Frame: From Baseline to 1 day after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.) ] [ Designated as safety issue: No ]
BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.
Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment [ Time Frame: From Baseline to 14 days after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.) ] [ Designated as safety issue: No ]
BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.
Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment [ Time Frame: From Baseline to 1 day after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.) ] [ Designated as safety issue: No ]
BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.
Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment [ Time Frame: From Baseline to 14 days after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.) ] [ Designated as safety issue: No ]
BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.


Enrollment:	113
Study Start Date:	February 2012
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Composite	Procedure: Restoration of dental caries with dental composite Dental Restoration (bisphenol A diglycidyl ether 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 (Child)
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


Responsible Party:	New England Research Institutes
ClinicalTrials.gov Identifier:	NCT01484132 History of Changes
Other Study ID Numbers:	1R01ES019155
Study First Received:	November 16, 2011
Results First Received:	May 15, 2015
Last Updated:	July 6, 2015
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 Tooth Demineralization Tooth Diseases Stomatognathic Diseases Bisphenol A Estrogens, Non-Steroidal Estrogens	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents

ClinicalTrials.gov processed this record on September 27, 2016