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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Materials Testing

Treatments: Procedure: Dental restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT02874599

S57171

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients

Experimental group

Description:

Patients who require multiple dental restorations. Teeth will be restored with commercial restorative composites

Treatment:

Procedure: Dental restoration