Trial Outcomes & Findings for Composites and Urinary Bisphenol-A Study (NCT NCT01484132)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

113 participants

Primary outcome timeframe

From Baseline to 6 months

Results posted on

2015-07-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Composite Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Study STARTED	113
Overall Study Pre-treatment Urine Sample	101
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Composite Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Overall Study Lost to Follow-up	8
Overall Study Difficulty with time commitment	2
Overall Study Ineligible	1
Overall Study No pre-treatment urine sample collected	1
Overall Study No post-treatment urine sample collected	10

Baseline Characteristics

Composites and Urinary Bisphenol-A Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Composite n=98 Participants Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Age, Continuous	9.36 Years STANDARD_DEVIATION 3.75 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Race/Ethnicity, Customized White - Non Hispanic	27 participants n=5 Participants
Race/Ethnicity, Customized Black - Non Hispanic	19 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	38 participants n=5 Participants
Race/Ethnicity, Customized Other	14 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Composite n=77 Participants Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months	0.29 ng/mL Standard Deviation 4.66

PRIMARY outcome

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.)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Composite n=89 Participants Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment	1.71 ng/mL Standard Deviation 9.94

PRIMARY outcome

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.)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Composite n=81 Participants Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment	-0.50 ng/mL Standard Deviation 4.09

PRIMARY outcome

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.)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Composite n=26 Participants Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment	-0.59 ng/mL Standard Deviation 3.62

PRIMARY outcome

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.)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Composite n=15 Participants Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment	-0.28 ng/mL Standard Deviation 3.55

Adverse Events

Composite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Felicia Trachtenberg, Principal Research Scientist

New England Research Institutes

Phone: 617-972-3120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place