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Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs

Primary Purpose

Tooth Wear

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gluma Universal
All Bond Universal
Single Bond2
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Wear

Eligibility Criteria

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

Inclusion Criteria:

Inclusion criteria will be as follows:

  1. being 18 years or older,
  2. having no medical or behavioral problems preventing then from attending review visits,
  3. having at least 7 tooth with NCCLs (d) having antagonist teeth.

Exclusion Criteria:

Exlusion criteria will be:

  1. poor gingival health,
  2. uncontrolled, rampant caries,
  3. bruxism,
  4. removable partial dentures,
  5. xerostomia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Gluma Universal, self-etch mode (GSE)

    Gluma Universal, selective etching (GSL)

    Gluma Universal, etch&rinse (GER)

    All Bond Universal, self-etch (ASE)

    All Bond Universal, selective etching (ASL)

    All Bond Universal, etch&rinse (AER)

    Single Bond2, etch&rinse (SBU)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Clinical performances of different adhesives
    Two year examinations according to USPHS criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2017
    Last Updated
    September 13, 2021
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03415516
    Brief Title
    Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs
    Official Title
    Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    November 1, 2015 (Actual)
    Study Completion Date
    November 1, 2018 (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 randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch&rinse, SB (Control): Single Bond2+etch&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Wear

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Gluma Universal, self-etch mode (GSE)
    Arm Type
    Experimental
    Arm Title
    Gluma Universal, selective etching (GSL)
    Arm Type
    Experimental
    Arm Title
    Gluma Universal, etch&rinse (GER)
    Arm Type
    Experimental
    Arm Title
    All Bond Universal, self-etch (ASE)
    Arm Type
    Experimental
    Arm Title
    All Bond Universal, selective etching (ASL)
    Arm Type
    Experimental
    Arm Title
    All Bond Universal, etch&rinse (AER)
    Arm Type
    Experimental
    Arm Title
    Single Bond2, etch&rinse (SBU)
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Gluma Universal
    Intervention Description
    Adhesive systems
    Intervention Type
    Device
    Intervention Name(s)
    All Bond Universal
    Intervention Description
    Adhesive systems
    Intervention Type
    Drug
    Intervention Name(s)
    Single Bond2
    Intervention Description
    Adhesive systems
    Primary Outcome Measure Information:
    Title
    Clinical performances of different adhesives
    Description
    Two year examinations 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: Inclusion criteria will be as follows: being 18 years or older, having no medical or behavioral problems preventing then from attending review visits, having at least 7 tooth with NCCLs (d) having antagonist teeth. Exclusion Criteria: Exlusion criteria will be: poor gingival health, uncontrolled, rampant caries, bruxism, removable partial dentures, xerostomia.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs

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