RCT to Evaluate Biocompatibility 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

NCT02874625

S57169

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Treatment 1

Active Comparator group

Description:

Dental restoration performed with glass-ionomer materials.

Treatment:

Procedure: Dental restoration

Treatment 2

Experimental group

Description:

Dental restoration performed with resin-based composites.

Treatment:

Procedure: Dental restoration