RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials

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.

Study Overview

• Status: Recruiting
• Conditions: Materials Testing
• Intervention / Treatment: Procedure: Dental restoration

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • BIOMAT, Department of Oral Health Sciences
    • Principal Investigator: Siemon De Nys
    • Contact: Kirsten L. Van Landuyt, Prof. Dr.; Phone Number: +3216373497; Email: siemon.denys@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment 1; Dental restoration performed with glass-ionomer materials.	Procedure: Dental restoration; Teeth with caries will be restored
Experimental: Treatment 2; Dental restoration performed with resin-based composites.	Procedure: Dental restoration; Teeth with caries will be restored

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary bisphenol A levels	1 year
Salivary bisphenol A levels	1 year
%DNA methylation	6 months
%DNA hydroxymethylation	6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimated): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S57169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No