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RCT to Evaluate Biocompatibility of Resin-based Dental Materials
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
In this randomized clinical trial, the bio-compatibility of 2 materials used for dental restorations will be compared: glass-ionomer vs resin-based composites. 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. Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined using UPLC-MS/MS.
Official title: Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials
Key Details
Gender
All
Age Range
4 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2017-08-30
Completion Date
2025-11
Last Updated
2024-07-03
Healthy Volunteers
Yes
Conditions
Interventions
Dental restoration
Teeth with caries will be restored
Locations (1)
BIOMAT, Department of Oral Health Sciences
Leuven, Belgium