Actively Recruiting
RCT to Evaluate Biocompatibility of Resin-based Dental Materials
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
200
Participants Needed
1
Research Sites
426 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
RCT to Evaluate Biocompatibility of Resin-based Dental Materials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- One or more carious lesions in primary molars that require treatment
You will not qualify if you...
- Carious lesions that have affected the dental pulp
- Large lesions requiring cusp replacement
- Presence of oral inflammatory conditions during the previous 2 weeks
- Carrying a fixed or removable prosthesis or orthodontic appliance
- Chronic disease requiring intake of drugs
- Exposure to diagnostic X-rays in the previous 2 months
- Previous dental restorations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BIOMAT, Department of Oral Health Sciences
Leuven, Belgium, 3000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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