RCT to Evaluate Biocompatibility of Resin-based Dental Materials
Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials
Universitaire Ziekenhuizen KU Leuven
200 participants
Aug 30, 2017
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- one or more carious lesions in primary molars that require treatment
Exclusion Criteria1
- 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
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Interventions
Teeth with caries will be restored
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02874625