- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04324008
Clinical Comparison of Different Flowable Resin Composites
December 20, 2022 updated by: Dr. Fatma Dilşad Öz, Hacettepe University
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Constic
Constic (DMG, Hamburg, Germany)
|
Flowable resin composite
|
Experimental: G-ænial Universal Flo
G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode)
|
Flowable resin composite
|
Experimental: Tetric N-Flow (self-etch)
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode)
|
Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)
|
Experimental: Tetric N-Flow (etch&rinse)
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch&rinse mode)
|
Tetric N-Flow (Tetric N-Bond Universal, etch&rinse mode)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical performances of different flowable resin composite
Time Frame: two years
|
Two year results according to USPHS criteria
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
January 1, 2018
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
March 25, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 20, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Flowable composites
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tooth Diseases
-
Aula Dental AvanzadaRecruitingTooth Extrusion | Tooth Fracture | Tooth Avulsion | Tooth ExtrudedSpain
-
National Institute of Dental and Craniofacial Research...RecruitingTooth Diseases | Diseases | Tooth | Stomatognatic | Tooth ImpactionUnited States
-
Colgate PalmoliveCompleted
-
HALEONActive, not recruitingTooth ErosionUnited States
-
Sun Yat-sen UniversityShenzhen Yunding Information Technology Co., Ltd.Recruiting
-
Shanghai Ninth People's Hospital Affiliated to...RecruitingTooth Decay | Tooth FractureChina
-
University of MichiganIvoclar Vivadent AGActive, not recruitingFractured Tooth | Decayed Tooth | Unsatisfactory Restoration of ToothUnited States
-
University of MichiganDentsply Sirona Implants and ConsumablesActive, not recruitingFractured Tooth | Decayed Tooth | Unsatisfactory Restoration of ToothUnited States
-
University of MichiganDentsply Sirona Inc.TerminatedFractured Tooth | Decayed Tooth | Unsatisfactory Restoration of ToothUnited States
-
Colgate PalmoliveCompleted