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RCT to Evaluate Biocompatibility of Resin-based Dental Materials

RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Recruiting
4-10 years
All
Phase N/A
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Overview

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.

Eligibility

Inclusion Criteria:

  • one or more carious lesions in primary molars that require treatment

Exclusion Criteria:

  • carious lesions that already affected the dental pulp, large lesions requiring cusp replacement, presence of oral inflammatory conditions during the previous 2 weeks, carriage of a fixed or removable prosthesis/orthodontic appliance, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in previous 2 months, previous dental restorations

Study details
    Materials Testing

NCT02874625

Universitaire Ziekenhuizen KU Leuven

15 October 2025

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