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Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials
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.
Age
4 - 10 years
Sex
ALL
Healthy Volunteers
Yes
BIOMAT, Department of Oral Health Sciences
Leuven, Belgium
Start Date
August 30, 2017
Primary Completion Date
January 1, 2025
Completion Date
November 1, 2025
Last Updated
July 3, 2024
200
ESTIMATED participants
Dental restoration
PROCEDURE
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Data Source & Attribution
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