N/A
N=20
Bisphenol A in Saliva and Urine Related to Placement of Dental Composites
Dental Polymer Based Filling Material
Bottom Line
View on ClinicalTrials.gov: NCT02575118 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Concentration of Bisphenol A in Saliva — 0.25 ng/ml — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Restoration of dental caries with dental composite (Device)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- NORCE Norwegian Research Centre AS
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Bisphenol A in Saliva |
0.25 | <0.05 sig |
| PRIMARY Concentration of Bisphenol A in Urine |
1.99 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02575118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.