Trials / Recruiting
RecruitingNCT02874625
RCT to Evaluate Biocompatibility of Resin-based Dental Materials
Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 4 Years – 10 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Dental restoration | Teeth with caries will be restored |
Timeline
- Start date
- 2017-08-30
- Primary completion
- 2025-01-01
- Completion
- 2025-11-01
- First posted
- 2016-08-22
- Last updated
- 2024-07-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02874625. Inclusion in this directory is not an endorsement.