Clinical Comparison of Different Adhesives in NCCLs
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2018
CompletedFirst Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2026
ExpectedSeptember 29, 2025
September 1, 2025
3 months
July 17, 2020
September 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performances of different adhesives
Two year examinations according to USPHS criteria
two years
Study Arms (5)
Clearfil Universal Bond Quick, self-etch mode (CU-SE)
EXPERIMENTALClearfil Universal Bond Quick, selective etch mode (CU-SLE)
EXPERIMENTALClearfil Universal Bond Quick, etch&rinse mode (CU-ER)
EXPERIMENTALClearfil SE Bond (CSE)
EXPERIMENTALTetric N-Bond (TB)
EXPERIMENTALInterventions
Adhesive systems
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 22, 2020
Study Start
February 10, 2018
Primary Completion
May 10, 2018
Study Completion (Estimated)
June 10, 2026
Last Updated
September 29, 2025
Record last verified: 2025-09