Materials Testing
Conditions
Brief 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.
Interventions
PROCEDUREDental restoration
Teeth with caries will be restored
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary bisphenol A levels | 1 year |
| Salivary bisphenol A levels | 1 year |
| %DNA methylation | 6 months |
| %DNA hydroxymethylation | 6 months |
Countries
Belgium
Outcome results
None listed