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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04694690
Other study ID # CAD/CAM-hybrid
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date August 20, 2024

Study information

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

Clinical Trial Summary

The clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. All hyrid ceramic restorations (Cerasmart, GC, Tokyo, Japan) will be produced using the same CAD/CAM CEREC Omnicam (Sirona Dental, Bensheim, Germany) system. 70 restorations will be divided into 2 groups: a self adhesive resin cement (RelyX U200 Automix, 3M ESPE, Seefeld, Germany), and an adhesive cement (G-Cem LinkForce, GC, Tokyo, Japan) which is applied after surface treatment (etch&rinse). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12, 18, 24, 36 and 48 months. Descriptive statistics will be performed using Friedman test and Chi-square test.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 53
Est. completion date August 20, 2024
Est. primary completion date February 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy individuals with or without systemic disease - Patiens older than 18 years old - Good oral health - Patients who at least have1 large and deep carious lesion or broken restoration in a vital tooth - Patients who agreed to participate in the study after being informed about this study Exclusion Criteria: - Patient with periodontal disease - Patients with partial dentures - Patients with bruxism - Patients with malooclusion - Non vital or endodontically treated teeth - Preparetions under the cemento-enamel junction

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self adhesive resin cement
Self adhesive resin cement
Resin cement
Resin Cement system used after surface treatment

Locations

Country Name City State
Turkey Hacettepe University Faculty of Dentistry 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 performance 18 months- Modified United States Public Health Service 18 months
See also
  Status Clinical Trial Phase
Terminated NCT01464294 - Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations N/A