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Clinical Performance of Different Resin Cements

Sponsor
Hacettepe University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04694690
Collaborator
(none)
53
Enrollment
1
Location
2
Arms
69
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self adhesive resin cement
  • Other: Resin cement
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Performance of Resin Cements in the Adhesion of CAD/CAM Restorations
Actual Study Start Date :
Nov 20, 2018
Actual Primary Completion Date :
Feb 20, 2019
Anticipated Study Completion Date :
Aug 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: RelyX U200 Automix Self Adhesive Resin Cement

Self Adhesive Resin Cement

Other: Self adhesive resin cement
Self adhesive resin cement
Other Names:
  • RelyX U 200

    		•
    Active Comparator: G-Cem LinkForce Resin Cement

    Resin Cement system used after surface treatment

    Other: Resin cement
    Resin Cement system used after surface treatment
    Other Names:
  • G-Cem LinkForce

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical performance [18 months]

      18 months- Modified United States Public Health Service

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Faculty of Dentistry Ankara Turkey 06060

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Simge Canatan, dentist, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04694690
    Other Study ID Numbers:
    • CAD/CAM-hybrid
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Simge Canatan, dentist, Hacettepe University
    CAD/CAM
    Inlay
    Onlay
    Hybrid ceramic
    Adhesive resin cement

    Study Results

    No Results Posted as of Jan 5, 2021