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Composites and Urinary Bisphenol-A Study (CUBS)

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ClinicalTrials.gov Identifier: NCT01484132
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Collaborators:
National Institute of Environmental Health Sciences (NIEHS)
Harvard School of Public Health
Information provided by (Responsible Party):
New England Research Institutes

Tracking Information
First Submitted Date  ICMJE November 16, 2011
First Posted Date  ICMJE December 2, 2011
Results First Submitted Date  ICMJE May 15, 2015
Results First Posted Date  ICMJE July 10, 2015
Last Update Posted Date July 10, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
  • Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months [ Time Frame: 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.
  • 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.) ]
    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.) ]
    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.) ]
    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.) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
  • Change from baseline in urinary bisphenol A level and 1 day [ Time Frame: Baseline and 1 day ]
  • Change from baseline in urinary bisphenol A level and 14 days [ Time Frame: Baseline and 14 days ]
  • Change from baseline in urinary bisphenol A level and 6 months [ Time Frame: Baseline and 6 months ]
Change History Complete list of historical versions of study NCT01484132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Composites and Urinary Bisphenol-A Study
Official Title  ICMJE Health Effects of Dental Composites in Children
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Composite
Intervention: Procedure: Restoration of dental caries with dental composite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2015)
113
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2011)
136
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01484132
Other Study ID Numbers  ICMJE 1R01ES019155( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New England Research Institutes
Study Sponsor  ICMJE New England Research Institutes
Collaborators  ICMJE
  • National Institute of Environmental Health Sciences (NIEHS)
  • Harvard School of Public Health
Investigators  ICMJE
Principal Investigator: Sonja McKinlay, PhD New England Research Institutes
PRS Account New England Research Institutes
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP