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NCT Number: NCT02874625

RCT to Evaluate 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.

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Key information

Conditions

Materials Testing

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIOMAT, Department of Oral Health Sciences

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Kirsten L. Van Landuyt, Prof. Dr.

CONTACT

[email protected]

+3216373497

Siemon De Nys

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental restoration

Procedure

Teeth with caries will be restored

Primary outcomes

  1. Urinary bisphenol A levels

    Time frame: 1 year

  2. Salivary bisphenol A levels

    Time frame: 1 year

  3. %DNA methylation

    Time frame: 6 months

  4. %DNA hydroxymethylation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2016
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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