Composites and Urinary Bisphenol-A Study

NCT01484132 | Completed Results

• 1 other identifier: 1R01ES019155
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental Caries; Dental Restorative Materials; Dental Composite; Bisphenol-A

Outcome Measures

Primary Outcomes (5)

• Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months

  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.

  From Baseline to 6 months

• Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment

  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.

  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.)

• Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment

  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.

  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.)

• Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment

  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.

  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.)

• Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment

  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.

  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.)

Study Arms (1)

Composite

EXPERIMENTAL

Procedure: Restoration of dental caries with dental composite

Interventions

Restoration of dental caries with dental composite PROCEDURE

Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

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

Composite

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 3-16 (\<17) years at enrollment.
• + posterior teeth with caries requiring restorations treatable by composite.
• Toilet-trained (not using diapers, pull-ups, or training pants during day or night).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carelon Research: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

New England Research Institutes, Inc.

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Felicia Trachtenberg, Principal Research Scientist
• Organization: New England Research Institutes

ftrachtenberg@neriscience.com

617-972-3120

Study Officials

• Sonja McKinlay, PhD

  Carelon Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: December 2, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 10, 2015
• Results First Posted: July 10, 2015

Record last verified: 2015-03

Locations

US (1)