Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns

April 4, 2024 updated by: Sherifa Ahmed Abdelaziz Kandil, Cairo University

Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial)

This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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

  • Egypt
      • Cairo, Egypt
        • Cairo University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Endodontically treated molar teeth indicated for endocrown.
  • Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth, -medically free

Exclusion Criteria:

  • ▪ Endodontically treated molar teeth indicated for post and core or only crown coverage.

    • Severe periodontal problems

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: Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns
Adding of short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns
Procedure: Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns
restoration of endodontically treated teeth by endocrowns
Other Names:
  • Grandio CAD/CAM block
Active Comparator: Lithium Disilicate (e.max) Endocrowns
Procedure: all ceramic Endocrowns (emax)
restoration of endodontically treated teeth by endocrowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical Fracture
Time Frame: change from baseline and months: 3, 6, 12
modified usphs criteria (alpha, bravo, charlie) with measuring unit: scoring system (ordinal)
change from baseline and months: 3, 6, 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance marginal adaptation
Time Frame: change from baseline and months: 3, 6, 12
modified usphs criteria (alpha, bravo, charlie) with measuring unit:scoring system (ordinal)
change from baseline and months: 3, 6, 12

Collaborators and Investigators

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

Sponsor

Cairo 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)

January 1, 2022

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD 5/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Dental Caries

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe