Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials

Universitaire Ziekenhuizen KU Leuven1 site in 1 country200 target enrollmentAugust 30, 2017

ConditionsMaterials Testing

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Materials Testing
Sponsor: Universitaire Ziekenhuizen KU Leuven
Enrollment: 200
Locations: 1
Primary Endpoint: Urinary bisphenol A levels
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 30, 2017

End Date

November 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitaire Ziekenhuizen KU Leuven

Responsible Party

Sponsor

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