RCT to Evaluate Biocompatibility of Resin-based Dental Materials

NCT ID: NCT02874625

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Materials Testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment 1

Dental restoration performed with glass-ionomer materials.

Group Type ACTIVE_COMPARATOR

Dental restoration

Intervention Type PROCEDURE

Teeth with caries will be restored

Treatment 2

Dental restoration performed with resin-based composites.

Group Type EXPERIMENTAL

Dental restoration

Intervention Type PROCEDURE

Teeth with caries will be restored

Interventions

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Dental restoration

Teeth with caries will be restored

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BIOMAT, Department of Oral Health Sciences

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Kirsten L. Van Landuyt, Prof. Dr.

Role: primary

+3216373497

Other Identifiers

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S57169

Identifier Type: -

Identifier Source: org_study_id

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