Wear Behavior of Milled Posterior Crowns Fabricated From the New Monolithic Zirconia 5Y-TZP/3Y-TZP Compared to Lithium Disilicate

June 9, 2021 updated by: Noran El-sharkawi, Cairo University

Wear Behavior of Milled Posterior Crowns Fabricated From the New Gradient Technology Monolithic Zirconia 5Y-TZP/3Y-TZP Compared to Lithium Disilicate: (Randomized Clinical Trial)

In-vitro studies do not represent the actual masticatory environment and cannot simulate the intricate chewing pattern. Hence, there is a need for an in vivo study evaluating the wear potential of the newly introduced strength - color gradient multilayered zirconia IPS e.max ZirCAD Prime (5Y-TZP/3Y-TZP) and compare it to Lithium Disilicate IPS e.max CAD which has proven to have favorable wear patterns.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • There will be no difference in wear caused by monolithic Zirconia (5Y-TZP/3Y-TZP) IPS E-max ZirCad Prime and Lithium Disilicate IPS e.max CAD to the antagonist.
  • There will be no difference in the wear of the new monolithic zirconia IPS e.max ZirCAD Prime and lithium disilicate IPS e.max CAD.

Study Type

Interventional

Enrollment (Anticipated)

24

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 Contact

Study Locations

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

21 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All subjects are required to:

    1- Be aged 21-50 years old, be able to read and sign the informed consent document. 2- Psychologically and physically able to withstand conventional dental procedures.

    3- Patients with mutilated posterior teeth indicated for full coverage restorations.

    4- Patients with sound natural antagonists. 5- Able to attend punctually for preplanned visits and evaluation. 6- Have no active periodontal or pulpal diseases.

    7- There should be no apparent loss or wear in opposing enamel.

Exclusion Criteria:

  1. Patient with active resistant periodontal diseases.
  2. Patients with parafunctional habits and bruxism.
  3. Patients with poor oral hygiene, high caries risk and uncooperative patients. 3- Pregnant women.
  4. Patients in the growth stage with partially erupted teeth. 5- Psychiatric problems or unrealistic expectations.

6- Lack of opposing dentition in the area of interest. 7- Restored occlusal surface opposing the planned restoration. 8- The presence of a removable or fixed orthodontic appliance.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lithium Disilicate IPS e.max crowns in posterior teeth
Other: Lithium Dislicate IPS e.max crown
wear of lithium disilicate IPS e.max crown in posterior teeth
EXPERIMENTAL: Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth
Other: monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime.
wear of the new material of monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime in posterior teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of occlusal wear in natural antagonist enamel caused by the restorative material
Time Frame: 1 year
The amount of occlusal wear in natural antagonist enamel, using digital superimposition of model scans after 1 year, measured in micrometer.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of occlusal wear in the restorative material itself
Time Frame: 1 year
The amount of occlusal wear in the restorative material itself, using digital superimposition of model scans after 1 year, measured in micrometers.
1 year

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 (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (ACTUAL)

March 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201020

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.

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