- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02575118
Bisphenol A in Saliva and Urine Related to Placement of Dental Composites
November 25, 2022 updated by: NORCE Norwegian Research Centre AS
Concentration of Bisphenol A in Saliva and Urine Before and After Treatment With Polymer-based Dental Filling Materials
It has been reported that therapy with polymer-based dental filling materials was associated with higher concentrations of bisphenol A in saliva and urine directly after the treatment.
The objective of the present project is to gain knowledge about the concentration of bisphenol A in saliva and urine before and after treatment with polymer-based dental filling materials, using sensitive analytical methods.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bisphenol A (BPA) is a xenoestrogen which has been shown to cause abnormalities in sexual development and may lead to reproductive damage in animals.
In epidemiological studies BPA has been associated with various health effects.
The majority of dental plastic filling materials contain polymers synthesized from BPA.
Whether BPA is released in vivo from polymer-based fillings and - if so, in what doses - is not sufficiently examined.
Patients scheduled for regular dental examination at the public dental clinic, Bergen Downtown District, who needs therapy with dental polymer-based filling materials and is suitable for study (inclusion / exclusion criteria) will be informed about the project.
If the patient wants to participate in the study, he/she will be given written information about the study and a consent form.
It is emphasized that participation in the study is voluntary and the patient will have the opportunity to read the information at home, before the next appointment at the clinic.
The clinical treatment of the carious lesion(s) will be performed according to standardized procedures and materials used at the clinic.
After curing, the filling will be polished according to the standard procedures.
The curing lamp will be controlled and documented weekly during the project period.
All treatment sessions will be scheduled in the morning before 9 am.
Questions regarding food intake and dental hygiene habits will be included in questionnaires answered during the study.
Samples of saliva and urine will be collected immediately before filling placement and 1 hour, 24 hours and 1 week after treatment.
A saliva sample will also be collected immediately after treatment.
No food or drink intake is allowed after midnight before sample collection.
Only tapped water is permitted.
The sampling procedure will be controlled in advance, so that the risk of contamination of samples is minimized.
After collection samples will be refrigerated and stored frozen at -80 °C until analysis.
Bisphenol A in saliva and urine will be determined by liquid chromatography and mass spectrometry (LC-MS).
The detection limit of the method is estimated at 0.1 ng BPA/ml.
The study is approved by the Regional Committee for Medical and Health Research (reference number 2014/1529).
Patients who participate in the project will have to collect saliva samples five times and urine samples four times, which involves extra visits to the clinic.
The biomedical outcomes (concentration of bisphenol A in saliva and urine) will be assessed in a pre-defined group of individuals.
The participants may be enrolled in the study if they fulfil the criteria (including need of a dental filling).
The participants do not receive the intervention (placement of a dental filling) because they are enrolled in the study.
Subjects in the study will receive the therapeutic intervention, but the investigator does not assign the intervention to the subjects of the study.
Thus, the study may be described as an observational study.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bergen, Norway
- Public dental clinic, Bergen Downtown District AND Dental Clinic of the Student Welfare Organization in Bergen
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for regular dental examination at the public dental clinic (Bergen Downtown District) and the Dental Clinic of the Student Welfare Organization in Bergen, who are in need for treatment with dental polymer-based filling materials, are suitable for study (inclusion / exclusion criteria) and have given their written informed consent.
Description
Inclusion Criteria:
- Need for filling therapy that involves at least two surfaces with a polymer-based filling material
- Healthy patient without any chronic diseases
- Age 16 - 40 years
- Informed consent given
Exclusion Criteria:
- Drug abuse
- Smoking
- Use of snuff
- Use of dental splint
- Work at a dental clinic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of Bisphenol A in Saliva
Time Frame: 1 week
|
Estimated bisphenol A (BPA) concentration (ng ml-1) in saliva
|
1 week
|
Concentration of Bisphenol A in Urine
Time Frame: 1 week
|
Estimated bisphenol A (BPA) concentration (ng ml-1) in urine
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Lars Björkman, DDS, PhD, NORCE Norwegian Research Centre AS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
October 5, 2015
First Submitted That Met QC Criteria
October 12, 2015
First Posted (Estimate)
October 14, 2015
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
November 25, 2022
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- REK 2014/1529
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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