RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Materials Testing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02874625
• Other study ID #: S57169
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 22, 2016
• Start date: January 2017

Study information

• Verified date: August 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Materials Testing

Intervention

Procedure:
• Dental restoration

Locations

Country	Name	City	State
Belgium	BIOMAT, Department of Oral Health Sciences	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary bisphenol A levels		1 year	No
Primary	Salivary bisphenol A levels		1 year	No
Primary	%DNA methylation		6 months	No
Primary	%DNA hydroxymethylation		6 months	No