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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Dental Caries
Intervention: Procedure: Restoration of dental caries with dental composite

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 113 children aged 3-17 were enrolled in Composites and Urinary Bisphenol-A Study (CUBS) across 8 dental clinics in Massachusetts between February 2012 and December 2013. Follow-up visits were completed in June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Composite Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

Participant Flow:   Overall Study
    Composite
STARTED   113 
Pre-treatment Urine Sample   101 [1] 
COMPLETED   91 [2] 
NOT COMPLETED   22 
Lost to Follow-up                8 
Difficulty with time commitment                2 
Ineligible                1 
No pre-treatment urine sample collected                1 
No post-treatment urine sample collected                10 
[1] Urine samples were collected twice pre-treatment. 101 subjects completed at least one urine sample.
[2] 91 subjects had at least one pre-treatment and at least one post-treatment urine sample.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
98 of 101 subjects who had the pre-treatment urine sample completed the baseline interview. Therefore, 98 subjects were included in the baseline analysis.

Reporting Groups
  Description
Composite Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

Baseline Measures
   Composite 
Overall Participants Analyzed 
[Units: Participants]
 98 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.36  (3.75) 
Gender 
[Units: Participants]
 
Female   46 
Male   52 
Race/Ethnicity, Customized 
[Units: Participants]
 
White - Non Hispanic   27 
Black - Non Hispanic   19 
Hispanic   38 
Other   14 


  Outcome Measures

1.  Primary:   Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months   [ Time Frame: From Baseline to 6 months ]

2.  Primary:   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.) ]

3.  Primary:   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.) ]

4.  Primary:   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.) ]

5.  Primary:   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.) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Felicia Trachtenberg, Principal Research Scientist
Organization: New England Research Institutes
phone: 617-972-3120
e-mail: ftrachtenberg@neriscience.com



Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT01484132     History of Changes
Other Study ID Numbers: 1R01ES019155 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2011
First Posted: December 2, 2011
Results First Submitted: May 15, 2015
Results First Posted: July 10, 2015
Last Update Posted: July 10, 2015