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

NCT02575118 | Completed Results

• 1 other identifier: REK 2014/1529
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Polymer Based Filling Material

Outcome Measures

Primary Outcomes (2)

• Concentration of Bisphenol A in Saliva

  Estimated bisphenol A (BPA) concentration (ng ml-1) in saliva

  1 week

• Concentration of Bisphenol A in Urine

  Estimated bisphenol A (BPA) concentration (ng ml-1) in urine

  1 week

Interventions

Restoration of dental caries with dental composite DEVICE

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Drug abuse
• Smoking
• Use of snuff
• Use of dental splint
• Work at a dental clinic

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead
• Hordaland County: collaborator

Study Sites (1)

Public dental clinic, Bergen Downtown District AND Dental Clinic of the Student Welfare Organization in Bergen

Bergen, Norway

Location

Related Publications (1)

• Berge TLL, Lygre GB, Lie SA, Lindh CH, Bjorkman L. Bisphenol A in human saliva and urine before and after treatment with dental polymer-based restorative materials. Eur J Oral Sci. 2019 Oct;127(5):435-444. doi: 10.1111/eos.12647. Epub 2019 Aug 8.

  PMID: 31392814 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva Urine

Results Point of Contact

• Title: Dr. Trine Lise Lundekvam Berge
• Organization: NORCE

trbe@norceresearch.no

+47 56 10 72 12

Study Officials

• Lars Björkman, DDS, PhD

  NORCE Norwegian Research Centre AS

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 18, 2023
• Results First Posted: January 18, 2023

Record last verified: 2018-05

Locations

NO (1)