RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Universitaire Ziekenhuizen KU Leuven200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

200

Conditions

Materials Testing

Interventions

Dental restoration

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Urinary bisphenol A levels

Time frame: 1 year

Salivary bisphenol A levels

Time frame: 1 year

%DNA methylation

Time frame: 6 months

%DNA hydroxymethylation