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

Primary Purpose

Tooth Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vertise Flow
LuxaFlow
Teco Adhesive
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 composite resin, occlusal caries

Eligibility Criteria

16 Years - 65 Years (Child, 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Vertise Flow

    LuxaFlow

    Arm Description

    Superficial Class I cavities restored with Vertise Flow

    Superficial Class I cavities restored with LuxaFlow

    Outcomes

    Primary Outcome Measures

    Clinical performances of flowable composite resins
    Five year results according to FDIcriteria

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2018
    Last Updated
    September 13, 2021
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03556553
    Brief Title
    Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
    Official Title
    Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 30, 2011 (Actual)
    Primary Completion Date
    June 30, 2011 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    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 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.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Vertise Flow
    Arm Type
    Experimental
    Arm Description
    Superficial Class I cavities restored with Vertise Flow
    Arm Title
    LuxaFlow
    Arm Type
    Experimental
    Arm Description
    Superficial Class I cavities restored with LuxaFlow
    Intervention Type
    Device
    Intervention Name(s)
    Vertise Flow
    Other Intervention Name(s)
    Self-adhering flowable composite
    Intervention Description
    Composite resin
    Intervention Type
    Device
    Intervention Name(s)
    LuxaFlow
    Other Intervention Name(s)
    Flowable composite with Teco adhesive system
    Intervention Description
    Composite resin
    Intervention Type
    Device
    Intervention Name(s)
    Teco Adhesive
    Intervention Description
    Adhesive system
    Primary Outcome Measure Information:
    Title
    Clinical performances of flowable composite resins
    Description
    Five year results according to FDIcriteria
    Time Frame
    Five years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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