Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2025-11-30

Brief Summary

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Adult patients who require multiple dental restorations will be included in this study. 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. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.

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Detailed Description

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Conditions

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Materials Testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients

Patients who require multiple dental restorations. Teeth will be restored with commercial restorative composites

Group Type EXPERIMENTAL

Dental restoration

Intervention Type PROCEDURE

Damaged teeth will be restored

Interventions

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Dental restoration

Damaged teeth will be restored

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Caucasian, adults,

Exclusion Criteria

* acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes