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NCT04481087 Clinical Trial

Clinical Comparison of Different Adhesives in NCCLs

Tooth Wear Clinical Trial

Official title:
Clinical Comparison of Different Adhesives in NCCLs

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04481087
Other study ID # NCCLs universal
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 10, 2018
Est. completion date June 10, 2024

Study information
Verified date April 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 34
Est. completion date June 10, 2024
Est. primary completion date May 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Clearfil Universal Bond Quick
Adhesive systems
• Clearfil Universal Bond Quick
Adhesive systems
• Clearfil Universal Bond Quick
Adhesive systems
• Clearfil SE Bond
Adhesive systems
• Tetric N-Bond
Adhesive systems

Locations
Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performances of different adhesives Two year examinations according to USPHS criteria two years
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