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Clinical Comparison of Different Flowable Resin Composites

Primary Purpose

Tooth Diseases

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Constic
G-ænial Universal Flo
Tetric N-Flow (self-etch)
Tetric N-Flow (etch&rinse)
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Diseases focused on measuring flowable resin composite, occlusal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • having no medical or behavioral problems preventing then from attending review visits
  • absence of previously placed restorations
  • having antagonist teeth

Exclusion Criteria:

  • poor gingival health
  • uncontrolled, rampant caries
  • bruxism
  • removable partial dentures
  • xerostomia

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Constic

G-ænial Universal Flo

Tetric N-Flow (self-etch)

Tetric N-Flow (etch&rinse)

Arm Description

Constic (DMG, Hamburg, Germany)

G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode)

Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode)

Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch&rinse mode)

Outcomes

Primary Outcome Measures

Clinical performances of different flowable resin composite
Two year results according to USPHS criteria

Secondary Outcome Measures

Full Information

First Posted
March 25, 2020
Last Updated
December 20, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04324008
Brief Title
Clinical Comparison of Different Flowable Resin Composites
Official Title
Clinical Comparison of Different Flowable Resin Composites
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate a self-adhesive flowable resin composite, a flowable resin composite with high viscosity and a conventional flowable resin composite in combination with a universal adhesive using two different application modes. All patients will receive at least 4 occlusal restorations. Cavities will be divided into four groups according to restorative systems used: Constic (a self-adhering flowable composite), G-ænial Universal Flo (a highly filled flowable composite), Tetric N-Flow (self-etch) (a conventional flowable composite), Tetrin N-Flow (etch&rinse).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
flowable resin composite, occlusal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Constic
Arm Type
Experimental
Arm Description
Constic (DMG, Hamburg, Germany)
Arm Title
G-ænial Universal Flo
Arm Type
Experimental
Arm Description
G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode)
Arm Title
Tetric N-Flow (self-etch)
Arm Type
Experimental
Arm Description
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode)
Arm Title
Tetric N-Flow (etch&rinse)
Arm Type
Experimental
Arm Description
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch&rinse mode)
Intervention Type
Device
Intervention Name(s)
Constic
Intervention Description
Flowable resin composite
Intervention Type
Device
Intervention Name(s)
G-ænial Universal Flo
Intervention Description
Flowable resin composite
Intervention Type
Device
Intervention Name(s)
Tetric N-Flow (self-etch)
Intervention Description
Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)
Intervention Type
Device
Intervention Name(s)
Tetric N-Flow (etch&rinse)
Intervention Description
Tetric N-Flow (Tetric N-Bond Universal, etch&rinse mode)
Primary Outcome Measure Information:
Title
Clinical performances of different flowable resin composite
Description
Two year results according to USPHS criteria
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: having no medical or behavioral problems preventing then from attending review visits absence of previously placed restorations having antagonist teeth Exclusion Criteria: poor gingival health uncontrolled, rampant caries bruxism removable partial dentures xerostomia
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Clinical Comparison of Different Flowable Resin Composites

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