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

Materials Testing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02874599
• Other study ID #: S57171
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 17, 2016
• Start date: October 2016

Study information

• Verified date: August 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Materials Testing

Intervention

Procedure:
• Dental restoration

Locations

Country	Name	City	State
Belgium	BIOMAT, Department of Oral Health Sciences	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary bisphenol A levels		1 year	No
Primary	Salivary bisphenol A levels		1 year	No
Primary	%DNA methylation		6 months	No
Primary	%DNA hydroxymethylation		6 months	No