- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481087
Clinical Comparison of Different Adhesives in NCCLs
September 26, 2025 updated by: Dr. Fatma Dilşad Öz, Hacettepe University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Hacettepe University
-
-
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
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: Clearfil Universal Bond Quick, self-etch mode (CU-SE)
|
Adhesive systems
|
|
Experimental: Clearfil Universal Bond Quick, selective etch mode (CU-SLE)
|
Adhesive systems
|
|
Experimental: Clearfil Universal Bond Quick, etch&rinse mode (CU-ER)
|
Adhesive systems
|
|
Experimental: Clearfil SE Bond (CSE)
|
Adhesive systems
|
|
Experimental: Tetric N-Bond (TB)
|
Adhesive systems
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical performances of different adhesives
Time Frame: two years
|
Two year examinations according to USPHS criteria
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 10, 2018
Primary Completion (Actual)
May 10, 2018
Study Completion (Estimated)
June 10, 2026
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
July 17, 2020
First Posted (Actual)
July 22, 2020
Study Record Updates
Last Update Posted (Estimated)
September 29, 2025
Last Update Submitted That Met QC Criteria
September 26, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCLs universal
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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