Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities

September 13, 2021 updated by: Dr. Fatma Dilşad Öz, Hacettepe University
The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients will receive at least one pair of class I restorations. After class I cavities were prepared they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch&rinse adhesive (Teco/DMG) [according to the manufacturers' instructions. Restorations will be evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc Nemar's.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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: Vertise Flow
Superficial Class I cavities restored with Vertise Flow
Device: Vertise Flow
Composite resin
Other Names:
  • Self-adhering flowable composite
Experimental: LuxaFlow
Superficial Class I cavities restored with LuxaFlow
Device: LuxaFlow
Composite resin
Other Names:
  • Flowable composite with Teco adhesive system
Device: Teco Adhesive
Adhesive system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performances of flowable composite resins
Time Frame: Five years
Five year results according to FDIcriteria
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

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)

March 30, 2011

Primary Completion (Actual)

June 30, 2011

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vertise-Luxa Flow

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.

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