Posterior TeethNCT04805281
Wear Behavior of Milled Posterior Crowns Fabricated From the New Monolithic Zirconia 5Y-TZP/3Y-TZP Compared to Lithium Disilicate
A study testing monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime. and Lithium Dislicate IPS e.max crown in people with Posterior Teeth and Worn Posterior Teeth, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Posterior Teeth, Worn Posterior Teeth, Endodontically Treated Teeth
- What is being tested?
- monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime. and Lithium Dislicate IPS e.max crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Rana Sherif, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11865
Noran El Sharkawi, MSc of fixed prosthodontics, 01006365953 ext. 02, noran.elsharqawy@dentistry.edu.eg
Rana Sherif
About this study
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)
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.
Read the 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.
- Conditions
- Posterior Teeth, Worn Posterior Teeth, Endodontically Treated Teeth, Crowned Posterior Teeth
- Being tested
- monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime., Lithium Dislicate IPS e.max crown
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime.Other
wear of the new material of monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime in posterior teeth
Lithium Dislicate IPS e.max crownOther
wear of lithium disilicate IPS e.max crown in posterior teeth
| Study group | Role | What they receive |
|---|---|---|
| Lithium Disilicate IPS e.max crowns in posterior teeth | Active comparator | Not described Receives: Other: Lithium Dislicate IPS e.max crown |
| Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth | Experimental | Not described Receives: Other: monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noran El-sharkawi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805281
- Sponsor's protocol ID
- 201020
- Status last verified
- Jun 2021
- First submitted
- 17 Feb 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04805281
- Acronym / sponsor ID
- 201020
- Conditions
- Posterior Teeth, Worn Posterior Teeth, Endodontically Treated Teeth, Crowned Posterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium Disilicate IPS e.max crowns in posterior teeth | Active comparator | Other: Lithium Dislicate IPS e.max crown |
| Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth | Experimental | Other: monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth |
| Lithium Dislicate IPS e.max crownwear of lithium disilicate IPS e.max crown in posterior teeth | Other | Lithium Disilicate IPS e.max crowns in posterior teeth |
Primary outcome
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 secondary outcome
The amount of occlusal wear in the restorative material itself
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Sherif, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime. and Lithium Dislicate IPS e.max crown in people with Posterior Teeth and Worn Posterior Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noran El Sharkawi, MSc (01006365953 ext. 02, noran.elsharqawy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of occlusal wear in natural antagonist enamel caused by the restorative material (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.