RCT to Evaluate Biocompatibility of Resin-based Dental Ma... | NCT02874625

Studies
RCT to Evaluate Biocompatibility of Resin-based Dental Materials

NCT02874625

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jul 3, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Materials Testing

Interventions

Dental restoration

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2017Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Aug 17, 2016

First Submission Date that Met QC Criteria

Aug 17, 2016

First Posted Date

Aug 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Name	Class
KU Leuven	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dental restoration	Procedure	Teeth with caries will be restored	Treatment 1 Treatment 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

one or more carious lesions in primary molars that require treatment

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BIOMAT, Department of Oral Health Sciences	Recruiting	Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided