RCT to Evaluate Biocompatibility of Resin-based Dental Materials
Not Applicable
Recruiting
- Conditions
- Materials Testing
- Interventions
- Procedure: Dental restoration
- Registration Number
- NCT02874625
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment 1 Dental restoration Dental restoration performed with glass-ionomer materials. Treatment 2 Dental restoration Dental restoration performed with resin-based composites.
- Primary Outcome Measures
Name Time Method Urinary bisphenol A levels 1 year %DNA hydroxymethylation 6 months Salivary bisphenol A levels 1 year %DNA methylation 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
BIOMAT, Department of Oral Health Sciences
🇧🇪Leuven, Belgium