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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02874599

Enrollment

100

Registered

2016-08-22

Start date

2018-05-02

Completion date

2025-11-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Materials Testing

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.

Interventions

PROCEDUREDental restoration

Damaged teeth will be restored

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Urinary bisphenol A levels	1 year
Salivary bisphenol A levels	1 year
%DNA methylation	6 months
%DNA hydroxymethylation	6 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026