Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns

October 22, 2022 updated by: Sameh Abou-steit, Cairo University

Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns (Randomized Clinical Trial)

The purpose of this study is to compare marginal adaptation, fracture, retention, shade matching and patient satisfaction between lithium disilicate (e.max) and hybrid nano-ceramic (Grandio) CAD/CAM endocrowns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with good oral hygiene
  • Patients having one or more endodontically treated molars that need prosthetic restoration.
  • Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
  • Fully erupted molars
  • Molars free of developmental defect
  • Healthy periodontium
  • Absence of periapical pathosis
  • Acceptable endodontic treatment and proper bone support

Exclusion Criteria:

  • Patients with bad oral hygiene
  • Patients with active periodontal disease
  • Patients with missing teeth opposing to the area intended for restoration
  • Patients with parafunctional habits or psychiatric problems or unrealistic expectation.

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
Active Comparator: Lithium disilicate
The intervention will be: Prosthetic endocrown
Procedure: Endocrown
Endocrown
Active Comparator: Hybrid nanoceramic
The intervention will be: Prosthetic endocrown
Procedure: Endocrown
Endocrown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 2 years
Using Binary Visual Analogue scale (Satisfied/ not satisfied)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shade matching
Time Frame: 2 years
Using the modified United States Public Health Service criteria (Modified USPHS)- categorical
2 years

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Sameh Sh Abou-steit, PhD, Lecturer of Fixed Prosthodontics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 11, 2019

Primary Completion (Actual)

March 11, 2022

Study Completion (Actual)

March 11, 2022

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 22, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-2019-3-080

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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