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

Not Applicable

Recruiting

• Conditions: Materials Testing

• Registration Number: NCT02874599
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-22
• Study Start: 2018-05-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
%DNA hydroxymethylation	6 months
Salivary bisphenol A levels	1 year
%DNA methylation	6 months
Urinary bisphenol A levels	1 year

Trial Locations

Locations (1)

BIOMAT, Department of Oral Health Sciences; 🇧🇪 Leuven, Belgium