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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
Enrollment 113
Recruitment Details 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  
Arm/Group Title Composite
Hide Arm/Group Description Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Period Title: Overall Study
Started 113
Pre-treatment Urine Sample 101 [1]
Completed 91 [2]
Not Completed 22
Reason Not Completed
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.
Arm/Group Title Composite
Hide Arm/Group Description Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
98 of 101 subjects who had the pre-treatment urine sample completed the baseline interview. Therefore, 98 subjects were included in the baseline analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
9.36  (3.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
46
  46.9%
Male
52
  53.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants
White - Non Hispanic 27
Black - Non Hispanic 19
Hispanic 38
Other 14
1.Primary Outcome
Title Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months
Hide Description 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.
Time Frame From Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 77 subjects who had BPA at 6 months were used.
Arm/Group Title Composite
Hide Arm/Group Description:
Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.29  (4.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Composite
Comments One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.
Method Regression, Linear
Comments Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.061
Confidence Interval (2-Sided) 95%
-0.206 to 0.084
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.
Method Mixed Models Analysis
Comments Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.017
Confidence Interval (2-Sided) 95%
-0.101 to 0.067
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.
Method Regression, Linear
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.123
Confidence Interval (2-Sided) 95%
-0.296 to 0.050
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.574
Comments P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.
Method Mixed Models Analysis
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.029
Confidence Interval (2-Sided) 95%
-0.131 to 0.073
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment
Hide Description 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.
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.)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 89 subjects who had BPA at 1 day after the first dental treatment were used.
Arm/Group Title Composite
Hide Arm/Group Description:
Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.71  (9.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Composite
Comments One sample t-test was used to test whether the mean change from baseline was different from 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.
Method Regression, Linear
Comments Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.299
Confidence Interval (2-Sided) 95%
0.105 to 0.494
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.
Method Regression, Linear
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.365
Confidence Interval (2-Sided) 95%
0.145 to 0.585
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment
Hide Description 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.
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.)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 81 subjects who had BPA at 14 days after the first dental treatment were used.
Arm/Group Title Composite
Hide Arm/Group Description:
Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: ng/mL
-0.50  (4.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Composite
Comments One sample t-test was used to test whether the mean change from baseline was different from 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.
Method Regression, Linear
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.068
Confidence Interval (2-Sided) 95%
-0.258 to 0.123
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.
Method Regression, Linear
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.074
Confidence Interval (2-Sided) 95%
-0.293 to 0.145
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment
Hide Description 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.
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.)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 26 subjects who had BPA at 1 day after the second dental treatment were used.
Arm/Group Title Composite
Hide Arm/Group Description:
Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
-0.59  (3.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Composite
Comments One sample t-test was used to test whether the mean change from baseline was different from 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.
Method Regression, Linear
Comments Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.082
Confidence Interval (2-Sided) 95%
-0.418 to 0.254
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.696
Comments P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.
Method Regression, Linear
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.078
Confidence Interval (2-Sided) 95%
-0.339 to 0.495
Estimation Comments [Not Specified]
5.Primary Outcome
Title Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment
Hide Description 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.
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.)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 15 subjects who had BPA at 14 days after the second dental treatment were used.
Arm/Group Title Composite
Hide Arm/Group Description:
Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
-0.28  (3.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Composite
Comments One sample t-test was used to test whether the mean change from baseline was different from 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.
Method Regression, Linear
Comments Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.018
Confidence Interval (2-Sided) 95%
-1.061 to 1.025
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Composite
Comments To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.822
Comments P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.
Method Regression, Linear
Comments Baseline BPA, season, household income, and canned food were used as covariates.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.083
Confidence Interval (2-Sided) 95%
-0.941 to 0.775
Estimation Comments [Not Specified]
Time Frame It is defined by the time between the first treatment visit and the last study visit (6 months), plus 1 day of observation for Adverse Event.
Adverse Event Reporting Description 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample were used as the total number of subjects at risk. No Adverse Event was reported in this study.
 
Arm/Group Title Composite
Hide Arm/Group Description Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)
All-Cause Mortality
Composite
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Composite
Affected / at Risk (%)
Total   0/91 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Composite
Affected / at Risk (%)
Total   0/91 (0.00%) 
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
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