Dental CariesCUBSNCT01484132

Composites and Urinary Bisphenol-A Study

A study testing Restoration of dental caries with dental composite in people with Dental Caries, run by Carelon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 17 years
Conditions the study is for: Dental Caries
What is being tested?: Restoration of dental caries with dental composite
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

New England Research Institutes, Inc.
Watertown, Massachusetts, 02472

Other trials in United States

About this study

Official title: Health Effects of Dental Composites in Children

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.

Read the 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.

Conditions: Dental Caries
Being tested: Restoration of dental caries with dental composite
Keywords: Dental Caries, Dental Restorative Materials, Dental Composite, Bisphenol-A
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restoration of dental caries with dental compositeProcedure or surgery
Also called Composite to be used is Z100 by 3M ESPE (St Paul, MN, USA).
Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)

Study groups in NCT01484132
Study group	Role	What they receive
Composite	Experimental	Not described Receives: Procedure: Restoration of dental caries with dental composite

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Urinary Bisphenol A Level (BPA) 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.
Measured: From Baseline to 6 months
Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day 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 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.
Measured: 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.)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days 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 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.
Measured: 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.)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second 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.
Measured: 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.)
Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second 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.
Measured: 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.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2014

First posted2 Dec 2011 (estimated)
Study startFeb 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01484132
Sponsor's protocol ID: 1R01ES019155
Acronym: CUBS
Status last verified: Mar 2015
First submitted: 16 Nov 2011
Last updated: 10 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dental Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Effects of Dental Composites in Children
ClinicalTrials.gov ID: NCT01484132
Acronym / sponsor ID: CUBS / 1R01ES019155
Conditions: Dental Caries
Keywords: Dental Caries, Dental Restorative Materials, Dental Composite, Bisphenol-A
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Carelon ResearchUniversity, hospital or other
Collaborators: National Institute of Environmental Health Sciences (NIEHS), Harvard School of Public Health (HSPH)
Study start: Feb 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 2 Dec 2011 (estimated)
Results: Posted 10 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Composite	Experimental	Procedure: Restoration of dental caries with dental composite

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Restoration of dental caries with dental compositeAlso: Composite to be used is Z100 by 3M ESPE (St Paul, MN, USA).Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)	Procedure or surgery	Composite

Primary outcome

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.

Results and safety

Results posted to the registry on 10 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Composite	113	91

Primary outcome: Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months

Time frame: From Baseline to 6 months. Mean (Standard Deviation). Unit: ng/mL

Measure	Composite n = 77
Value	0.29 (4.66)

Composite: p = 0.58, t-test, 2 sided
Composite: Slope: -0.061 (95% CI -0.206 to 0.084), p = 0.406, Regression, Linear
Composite: Slope: -0.017 (95% CI -0.101 to 0.067), p = 0.693, Mixed Models Analysis

Population analysed: 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.

Primary outcome: 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.). Mean (Standard Deviation). Unit: ng/mL

Measure	Composite n = 89
Value	1.71 (9.94)

Composite: p = 0.11, t-test, 2 sided
Composite: Slope: 0.299 (95% CI 0.105 to 0.494), p = 0.003, Regression, Linear
Composite: Slope: 0.365 (95% CI 0.145 to 0.585), p = 0.002, Regression, Linear

Population analysed: 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.

Primary outcome: 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.). Mean (Standard Deviation). Unit: ng/mL

Measure	Composite n = 81
Value	-0.50 (4.09)

Composite: p = 0.27, t-test, 2 sided
Composite: Slope: -0.068 (95% CI -0.258 to 0.123), p = 0.480, Regression, Linear
Composite: Slope: -0.074 (95% CI -0.293 to 0.145), p = 0.501, Regression, Linear

Population analysed: 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.

Primary outcome: 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.). Mean (Standard Deviation). Unit: ng/mL

Measure	Composite n = 26
Value	-0.59 (3.62)

Composite: p = 0.41, t-test, 2 sided
Composite: Slope: -0.082 (95% CI -0.418 to 0.254), p = 0.612, Regression, Linear
Composite: Slope: 0.078 (95% CI -0.339 to 0.495), p = 0.696, Regression, Linear

Population analysed: 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.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Composite	0 of 91 (0%)	0 of 91 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sonja McKinlay, PhD principal investigator

Carelon Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Restoration of dental caries with dental composite in people with Dental Caries, run by Carelon Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months (time frame: From Baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01484132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.