RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Not Applicable

Recruiting

• Conditions: Materials Testing

• Registration Number: NCT02874625
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

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: 2017-08-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-01
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

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