Clinical Comparison of Different Adhesives in NCCLs
Primary Purpose
Tooth Wear
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clearfil Universal Bond Quick
Clearfil Universal Bond Quick
Clearfil Universal Bond Quick
Clearfil SE Bond
Tetric N-Bond
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Wear
Eligibility Criteria
Inclusion Criteria:
- being 18 years or older,
- having no medical or behavioral problems preventing then from attending review visits,
- having at least 5 tooth with NCCLs
- having antagonist teeth
Exclusion Criteria:
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Clearfil Universal Bond Quick, self-etch mode (CU-SE)
Clearfil Universal Bond Quick, selective etch mode (CU-SLE)
Clearfil Universal Bond Quick, etch&rinse mode (CU-ER)
Clearfil SE Bond (CSE)
Tetric N-Bond (TB)
Arm Description
Outcomes
Primary Outcome Measures
Clinical performances of different adhesives
Two year examinations according to USPHS criteria
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04481087
Brief Title
Clinical Comparison of Different Adhesives in NCCLs
Official Title
Clinical Comparison of Different Adhesives in NCCLs
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
June 10, 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 the performances of a universal adhesive in three different application modes, a self-etch adhesive and an etch&rinse adhesive in restoration of non-caries cervical lesions. Thirty-four patients will receive restorations. Lesions will be divided into 5 groups according to adhesive systems and application modes: CU-SE: Clearfil Universal Bond Quick in self-etch mode, CU-SLE: Clearfil Universal Bond Quick in selective etch mode, CU-ER: Clearfil Universal Bond Quick in etch&rinse mode, CSE: Clearfil SE Bond, TB: Tetric N-Bond. Restorations (Tetric N-Ceram 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
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clearfil Universal Bond Quick, self-etch mode (CU-SE)
Arm Type
Experimental
Arm Title
Clearfil Universal Bond Quick, selective etch mode (CU-SLE)
Arm Type
Experimental
Arm Title
Clearfil Universal Bond Quick, etch&rinse mode (CU-ER)
Arm Type
Experimental
Arm Title
Clearfil SE Bond (CSE)
Arm Type
Experimental
Arm Title
Tetric N-Bond (TB)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Clearfil Universal Bond Quick
Intervention Description
Adhesive systems
Intervention Type
Device
Intervention Name(s)
Clearfil Universal Bond Quick
Intervention Description
Adhesive systems
Intervention Type
Device
Intervention Name(s)
Clearfil Universal Bond Quick
Intervention Description
Adhesive systems
Intervention Type
Device
Intervention Name(s)
Clearfil SE Bond
Intervention Description
Adhesive systems
Intervention Type
Device
Intervention Name(s)
Tetric N-Bond
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:
being 18 years or older,
having no medical or behavioral problems preventing then from attending review visits,
having at least 5 tooth with NCCLs
having antagonist teeth
Exclusion Criteria:
poor gingival health,
uncontrolled, rampant caries,
bruxism,
removable partial dentures,
xerostomia
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Different Adhesives in NCCLs
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