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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04805281
Other study ID # 201020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date June 1, 2022

Study information

Verified date June 2021
Source Cairo University
Contact Noran El Sharkawi, MSc
Phone 01006365953
Email noran.elsharqawy@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date June 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary 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. 1 year
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