NCT02874599

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

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
1.7 years until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day 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

7.5 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 (1)

Patients

EXPERIMENTAL

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

Procedure: Dental restoration

Interventions

Dental restorationPROCEDURE

Damaged teeth will be restored

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian, adults,

You may not qualify if:

  • 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

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
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

May 2, 2018

Primary Completion

November 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)