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Bisphenol A in Saliva and Urine Related to Placement of Dental Composites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02575118
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : May 25, 2016
Hordaland County Council
Information provided by (Responsible Party):
Uni Research

Brief Summary:
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.

Condition or disease Intervention/treatment
Dental Polymer Based Filling Material Device: Restoration of dental caries with dental composite

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
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Concentration of Bisphenol A in Saliva and Urine Before and After Treatment With Polymer-based Dental Filling Materials
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Concentration of bisphenol A in saliva [ Time Frame: 1 week ]
  2. Concentration of bisphenol A in urine [ Time Frame: 1 week ]

Biospecimen Retention:   Samples Without DNA
Saliva Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for regular dental examination at the public dental clinic, Bergen Downtown District, 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.

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 - 30 years
  • Informed consent given

Exclusion Criteria:

  • Drug abuse
  • Smoking
  • Use of snuff
  • Previously treated with polymer-based dental materials (e.g. fissure sealants, fillings, fixed or removable prosthetic restorations or orthodontic apparatus).
  • Use of dental splint
  • Work at a dental clinic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02575118

Contact: Trine-Lise L Berge, DDS +4790678591

Public dental clinic, Bergen Downtown District AND Dental Clinic of the Student Welfare Organization in Bergen Recruiting
Bergen, Norway
Contact: Trine Lise L Berge, DDS         
Sponsors and Collaborators
Uni Research
Hordaland County Council
Study Chair: Lars Björkman, DDS, PhD Uni Research

Responsible Party: Uni Research Identifier: NCT02575118     History of Changes
Other Study ID Numbers: REK 2014/1529
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Bisphenol A
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents