NCT02874625

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

7.3 years

First QC Date

August 17, 2016

Last Update Submit

July 2, 2024

Conditions

Materials Testing

Outcome Measures

Primary Outcomes (4)

  • Urinary bisphenol A levels

    1 year

  • Salivary bisphenol A levels

    1 year

  • %DNA methylation

    6 months

  • %DNA hydroxymethylation

    6 months

Study Arms (2)

Treatment 1

ACTIVE COMPARATOR

Dental restoration performed with glass-ionomer materials.

Procedure: Dental restoration

Treatment 2

EXPERIMENTAL

Dental restoration performed with resin-based composites.

Procedure: Dental restoration

Interventions

Dental restorationPROCEDURE

Teeth with caries will be restored

Treatment 1Treatment 2

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • one or more carious lesions in primary molars that require treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIOMAT, Department of Oral Health Sciences

Leuven, 3000, Belgium

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

August 30, 2017

Primary Completion

January 1, 2025

Study Completion

November 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)