Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
Not Applicable
Recruiting
- Conditions
- Materials Testing
- Interventions
- Procedure: Dental restoration
- Registration Number
- NCT02874599
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.
Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Caucasian, adults,
Exclusion Criteria
- acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients Dental restoration Patients who require multiple dental restorations. Teeth will be restored with commercial restorative composites
- Primary Outcome Measures
Name Time Method Urinary bisphenol A levels 1 year %DNA hydroxymethylation 6 months Salivary bisphenol A levels 1 year %DNA methylation 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
BIOMAT, Department of Oral Health Sciences
🇧🇪Leuven, Belgium