Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials

Universitaire Ziekenhuizen KU Leuven100 enrolled

Overview

Adult patients who require multiple dental restorations will be included in this study. 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. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Materials Testing

Interventions

Dental restorationPROCEDURE

Damaged teeth will be restored

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Caucasian, adults, Exclusion Criteria: * acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol

Locations (1)

BIOMAT, Department of Oral Health Sciences

Leuven, Belgium

RECRUITING

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

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.