Clinical Performance of Different Resin Cements

February 26, 2024 updated by: Simge Canatan, Hacettepe University

Clinical Performance of Resin Cements in the Adhesion of CAD/CAM Restorations

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

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

  • Turkey
      • Ankara, Turkey, 06060
        • Hacettepe University Faculty of Dentistry

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: 18 months
18 months- Modified United States Public Health Service
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

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)

November 20, 2018

Primary Completion (Actual)

February 20, 2019

Study Completion (Estimated)

August 20, 2024

Study Registration Dates

First Submitted

January 2, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAD/CAM-hybrid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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