Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT01484132
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2011-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Composites and Urinary Bisphenol-A Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ftrachtenberg@neriscience.com', 'phone': '617-972-3120', 'title': 'Felicia Trachtenberg, Principal Research Scientist', 'organization': 'New England Research Institutes'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '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.', '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)', 'otherNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '4.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.406', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.061', 'ciLowerLimit': '-0.206', 'ciUpperLimit': '0.084', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.693', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.017', 'ciLowerLimit': '-0.101', 'ciUpperLimit': '0.067', 'pValueComment': 'P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.', 'groupDescription': '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.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.160', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.123', 'ciLowerLimit': '-0.296', 'ciUpperLimit': '0.050', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.574', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.029', 'ciLowerLimit': '-0.131', 'ciUpperLimit': '0.073', 'pValueComment': 'P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.', 'groupDescription': '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.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 6 months', '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '9.94', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'One sample t-test was used to test whether the mean change from baseline was different from 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.299', 'ciLowerLimit': '0.105', 'ciUpperLimit': '0.494', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.365', 'ciLowerLimit': '0.145', 'ciUpperLimit': '0.585', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '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.)', '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '4.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'One sample t-test was used to test whether the mean change from baseline was different from 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.480', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.068', 'ciLowerLimit': '-0.258', 'ciUpperLimit': '0.123', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.501', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.074', 'ciLowerLimit': '-0.293', 'ciUpperLimit': '0.145', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '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.)', '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.59', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'One sample t-test was used to test whether the mean change from baseline was different from 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.612', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.082', 'ciLowerLimit': '-0.418', 'ciUpperLimit': '0.254', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.696', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.078', 'ciLowerLimit': '-0.339', 'ciUpperLimit': '0.495', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '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.)', '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '3.55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'One sample t-test was used to test whether the mean change from baseline was different from 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.968', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-1.061', 'ciUpperLimit': '1.025', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}, {'pValue': '0.822', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.083', 'ciLowerLimit': '-0.941', 'ciUpperLimit': '0.775', 'pValueComment': '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.', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline BPA, season, household income, and canned food were used as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '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.)', '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}]}, {'type': 'Pre-treatment Urine Sample', 'achievements': [{'comment': 'Urine samples were collected twice pre-treatment. 101 subjects completed at least one urine sample.', 'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '91 subjects had at least one pre-treatment and at least one post-treatment urine sample.', 'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Difficulty with time commitment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No pre-treatment urine sample collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No post-treatment urine sample collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Composite', 'description': 'Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.36', 'spread': '3.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White - Non Hispanic', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Black - Non Hispanic', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '98 of 101 subjects who had the pre-treatment urine sample completed the baseline interview. Therefore, 98 subjects were included in the baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-06', 'studyFirstSubmitDate': '2011-11-16', 'resultsFirstSubmitDate': '2015-05-15', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-06', 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months', 'timeFrame': 'From Baseline to 6 months', '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.'}, {'measure': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment', 'timeFrame': '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.)', '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.'}, {'measure': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment', 'timeFrame': '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.)', '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.'}, {'measure': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment', 'timeFrame': '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.)', '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.'}, {'measure': 'Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment', 'timeFrame': '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.)', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental Caries', 'Dental Restorative Materials', 'Dental Composite', 'Bisphenol-A'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 3-16 (\\<17) years at enrollment.\n* 2+ posterior teeth with caries requiring restorations treatable by composite.\n* Toilet-trained (not using diapers, pull-ups, or training pants during day or night).\n\nExclusion Criteria:\n\n* Medical conditions that would render the subject physically unable to provide urine samples.\n* Guardian is not proficient in spoken English or Spanish language\n* Child is aged 8.0 years or older and not proficient in spoken English or Spanish language\n* Living \\>35 miles outside of the dental clinic or the NERI office (Watertown MA)'}, 'identificationModule': {'nctId': 'NCT01484132', 'acronym': 'CUBS', 'briefTitle': 'Composites and Urinary Bisphenol-A Study', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Health Effects of Dental Composites in Children', 'orgStudyIdInfo': {'id': '1R01ES019155', 'link': 'https://reporter.nih.gov/quickSearch/1R01ES019155', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Composite', 'interventionNames': ['Procedure: Restoration of dental caries with dental composite']}], 'interventions': [{'name': 'Restoration of dental caries with dental composite', 'type': 'PROCEDURE', 'otherNames': ['Composite to be used is Z100 by 3M ESPE (St Paul, MN, USA).'], 'description': 'Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)', 'armGroupLabels': ['Composite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Research Institutes, Inc.', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}], 'overallOfficials': [{'name': 'Sonja McKinlay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carelon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}