Clinical Comparison of Bulk-fill and Incremental Composite | NCT04685954

Studies
Clinical Comparison of Bulk-fill and Incremental Composite

NCT04685954

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Feb 17, 2021Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Tooth Disease

Interventions

Filtek Bulk-Fill Posterior
Filtek Ultimate Universal

Countries

Turkey (Türkiye)

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Dec 22, 2020

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 28, 2020Actual

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

Feb 14, 2021

Last Update Posted Date

Feb 17, 2021Actual

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

The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin [Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)] and an incremental posterior composite resin [Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bulk-Fill	Experimental	Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)	Device: Filtek Bulk-Fill Posterior
Incremental	Experimental	Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)	Device: Filtek Ultimate Universal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Filtek Bulk-Fill Posterior	Device	Bulk-fill restorative composite	Bulk-Fill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical performances of different restorative systems according to USPHS criteria	Two year results according to USPHS criteria	two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age range will be 18 to 65
patients should have at least 2 approximal caries lesions require restoration
healthy periodontal status
a good likelihood of recall availability

Exclusion Criteria:

poor gingival health
adverse medical history
potential behavioral problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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
Hacettepe University		Ankara			Turkey (Türkiye)

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

Condition Browse Module

MeSH Terms

ID	Term
D014076	Tooth Diseases

Ancestor Terms

ID	Term
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided