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

Primary Purpose

Posterior Teeth, Worn Posterior Teeth, Endodontically Treated Teeth

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime.

Lithium Dislicate IPS e.max crown

About this trial

This is an interventional other trial for Posterior Teeth

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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:

Patient with active resistant periodontal diseases.
Patients with parafunctional habits and bruxism.
Patients with poor oral hygiene, high caries risk and uncooperative patients. 3- Pregnant women.
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.

Sites / Locations

Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lithium Disilicate IPS e.max crowns in posterior teeth

Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth

Arm Description

Outcomes

Primary Outcome Measures

The amount of occlusal wear in natural antagonist enamel caused by the restorative material

The amount of occlusal wear in natural antagonist enamel, using digital superimposition of model scans after 1 year, measured in micrometer.

Secondary Outcome Measures

The amount of occlusal wear in the restorative material itself

The amount of occlusal wear in the restorative material itself, using digital superimposition of model scans after 1 year, measured in micrometers.

Full Information

NCT ID

NCT04805281

First Posted

February 17, 2021

Last Updated

June 9, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04805281

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2021 (Anticipated)

Primary Completion Date

March 1, 2022 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posterior Teeth, Worn Posterior Teeth, Endodontically Treated Teeth, Crowned Posterior Teeth

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lithium Disilicate IPS e.max crowns in posterior teeth

Arm Type

Active Comparator

Arm Title

Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime.

Intervention Description

wear of the new material of monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime in posterior teeth

Intervention Type

Other

Intervention Name(s)

Lithium Dislicate IPS e.max crown

Intervention Description

wear of lithium disilicate IPS e.max crown in posterior teeth

Primary Outcome Measure Information:

Title

The amount of occlusal wear in natural antagonist enamel caused by the restorative material

Description

The amount of occlusal wear in natural antagonist enamel, using digital superimposition of model scans after 1 year, measured in micrometer.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The amount of occlusal wear in the restorative material itself

Description

The amount of occlusal wear in the restorative material itself, using digital superimposition of model scans after 1 year, measured in micrometers.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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: Patient with active resistant periodontal diseases. Patients with parafunctional habits and bruxism. Patients with poor oral hygiene, high caries risk and uncooperative patients. 3- Pregnant women. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noran El Sharkawi, MSc

Phone

01006365953

Ext

noran.elsharqawy@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Rana Sherif, professor

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

11865

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noran El Sharkawi, MSc of fixed prosthodontics

Phone

01006365953

Ext

noran.elsharqawy@dentistry.edu.eg

First Name & Middle Initial & Last Name & Degree

Rana Sherif

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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