Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805281
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Noran El-sharkawi, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posterior Teeth Worn Posterior Teeth Endodontically Treated Teeth Crowned Posterior Teeth Other: monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime. Other: Lithium Dislicate IPS e.max crown Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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)
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805281


Contacts
Layout table for location contacts
Contact: Noran El Sharkawi, MSc 01006365953 ext 02 noran.elsharqawy@dentistry.cu.edu.eg
Contact: Rana Sherif, professor

Locations
Layout table for location information
Egypt
Cairo University Recruiting
Cairo, Egypt, 11865
Contact: Noran El Sharkawi, MSc of fixed prosthodontics    01006365953 ext 02    noran.elsharqawy@dentistry.edu.eg   
Contact: Rana Sherif         
Sponsors and Collaborators
Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Noran El-sharkawi, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04805281    
Other Study ID Numbers: 201020
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs