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Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions

Primary Purpose

Tooth Diseases

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clearfil Univesal Bond
IBond Universal
G-Premio Bond
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 non-caries cervical lesion, universal adhesives

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.

Exclusion Criteria:

  • Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group CU (Clearfil Universal)

    Group IU (Ibond Universal)

    Group GP (G-Premio)

    Arm Description

    Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system

    IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system

    G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system

    Outcomes

    Primary Outcome Measures

    Clinical performances of different universal adhesives
    Two year results according to USPHS criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2017
    Last Updated
    August 21, 2023
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03415412
    Brief Title
    Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions
    Official Title
    Clinical Evaluation of Three Different Universal Adhesives and a Universal Flowable Composite for Restoration of Non-carious Cervical Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    June 1, 2016 (Actual)
    Study Completion Date
    June 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 randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation. The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA). Patients will be recalled at baseline and will be recalled at control periods after placement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Diseases
    Keywords
    non-caries cervical lesion, universal adhesives

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group CU (Clearfil Universal)
    Arm Type
    Experimental
    Arm Description
    Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system
    Arm Title
    Group IU (Ibond Universal)
    Arm Type
    Experimental
    Arm Description
    IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system
    Arm Title
    Group GP (G-Premio)
    Arm Type
    Experimental
    Arm Description
    G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system
    Intervention Type
    Device
    Intervention Name(s)
    Clearfil Univesal Bond
    Intervention Description
    Adhesive systems
    Intervention Type
    Device
    Intervention Name(s)
    IBond Universal
    Intervention Description
    Adhesive systems
    Intervention Type
    Device
    Intervention Name(s)
    G-Premio Bond
    Intervention Description
    Adhesive systems
    Primary Outcome Measure Information:
    Title
    Clinical performances of different universal adhesives
    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: 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm. Exclusion Criteria: Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35477817
    Citation
    Oz FD, Ozturk C, Soleimani R, Gurgan S. Sixty-month follow up of three different universal adhesives used with a highly-filled flowable resin composite in the restoration of non-carious cervical lesion. Clin Oral Investig. 2022 Aug;26(8):5377-5387. doi: 10.1007/s00784-022-04505-x. Epub 2022 Apr 27.
    Results Reference
    derived

    Learn more about this trial

    Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions

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