RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Aug 17, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and compatibility of two types of materials used for dental fillings: glass-ionomer and resin-based composites. Researchers want to see how these materials affect the body by measuring certain substances in urine and saliva, as well as looking at changes in DNA from cells in the mouth. The goal is to understand if one material is better or safer than the other for dental treatments.

To participate in this study, you should be between 4 and 10 years old and have one or more cavities in your back teeth that need to be treated. However, if you have certain conditions like a bad cavity that has reached the nerve, or if you've had dental work done recently, you may not be eligible. If you join the trial, you can expect to provide some samples (like urine and saliva) and have some simple tests done to help researchers gather the information they need. This study aims to ensure that dental materials are safe for children, so your participation could help improve dental care for others!

Gender

ALL

Eligibility criteria

• 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