Clinical Behavior of ZLS and UTMLNCT07521501
Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design
A study testing UTML (KATANA) crowns with conservative marginal design and ZLS (AMBRIA) crowns with conservative marginal design in people with Clinical Behavior of ZLS and UTML, run by Cairo University.
Trial summary
The aim of the present study is to evaluate clinical behavior and patient satisfaction of Zirconia-reinforced lithium disilicate press ceramic crowns when used in a conservative marginal design(0.6mm chamfer finish line). Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Clinical Behavior of ZLS and UTML
- What is being tested?
- UTML (KATANA) crowns with conservative marginal design and ZLS (AMBRIA) crowns with conservative marginal design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The age range of the patients from 21- 50 years old; able to read and sign the informed consent document; illiterate patients will be avoided.
- Patients who can physically and psychologically tolerate conventional restorative procedures.
- Patients with endodontically treated teeth indicated for ceramic crowns in the esthetic Zone (all axial walls existing).
- Patients with no active periodontal or pulpal diseases.
- Patients with teeth problems indicated for full coverage restoration in the esthetic zone (e.g.
- moderate to severe discoloration, coronal chipping where partial coverage would lack retention, malposed or malformed teeth). 6. Patients willing to return for follow-up examinations and evaluation. 7. Patients that care for good oral hygiene Maintenance.
Who cannot join
- 1 Patients with poor oral hygiene and motivation. 2. high caries rate. 3. Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch). 4. Patients suffering from parafunctional habits or temporomandibular disorders.
- 7. Patients with teeth have extensive tooth structure loss, even if one wall is missing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design (A Randomized Controlled Clinical Trial)
The aim of the present study is to evaluate clinical behavior and patient satisfaction of Zirconia-reinforced lithium disilicate press ceramic crowns when used in a conservative marginal design(0.6mm chamfer finish line). Comparison with Ultratranslucent multilayered monolithic zirconiacrowns will also be carried out in terms of marginal integrity, fracture, color stability and gingival health for 12 month
Read the detailed description
- Select and examine patients based on inclusion/exclusion criteria, then obtain consent.
- Diagnose chief complaint, assess teeth in the esthetic zone, and perform scaling/polishing.
- Take primary impressions for study casts.
- Instruct patients to brush three times daily for good oral hygiene.
- Capture pre-op photos and radiographs.
- Choose the appropriate shade.
- Tooth Preparation:
- Group 1: Ultra-translucent zirconia crown (CAD/CAM, 0.6mm chamfer).
- Group 2: Zirconia-reinforced lithium disilicate crown (press, 0.6mm chamfer).
- Perform tissue retraction and take impressions with IOS.
- Create provisional crowns.
- Fabricate crowns (AMBRIA or KATANA zirconia) per manufacturer guidelines.
- Conduct try-in.
- Cement using light-cured resin adhesive.
- Assess restoration at 3, 6, 9 and 12 months for clinical behavior and patient satisfaction
- Conditions
- Clinical Behavior of ZLS and UTML
- Being tested
- UTML (KATANA) crowns with conservative marginal design, ZLS (AMBRIA) crowns with conservative marginal design
- Keywords
- KATANA (UTML zirconia), AMBRIA (zirconia reinforced glass ceramic), clinical behavior, patient satisfaction, conservative marginal design
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTML (KATANA) crowns with conservative marginal designDevice
Monolithic zirconia (KATANA UTML) crown fabricated with CAD/CAM and a conservative 0.6 mm marginal design.
ZLS (AMBRIA) crowns with conservative marginal designDevice
Zirconia-reinforced lithium silicate press ceramic (Ambria) crown with conservative 0.6 mm marginal design.
| Study group | Role | What they receive |
|---|---|---|
| UTML (KATANA) crowns arm | Active comparator | Patients will receive ultra-translucent multilayered monolithic zirconia crowns ( KATANA UTML) fabricated using CAD/CAM with conservative marginal design (0.6 mm). Receives: Device: UTML (KATANA) crowns with conservative marginal design |
| ZLS crowns arm | Experimental | Patients will receive zirconia-reinforced lithium silicate press ceramic crowns ( VITA Ambria) with conservative marginal design (0.6 mm). Receives: Device: ZLS (AMBRIA) crowns with conservative marginal design |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical behavior
Marginal integrity:
Measuring device: Modified USPHS criteria. Measuring unit: Discrete (scores).
Measured: 12 months follow-up interval
Fracture:
Description: Measuring device: Modified USPHS criteria Measuring unit: Discrete (scores).
Measured: Time Frame: 12 months follow-up interval.
Color stability:
Description: Measuring device: Spectrophotometer Measuring unit: ΔE.
Measured: Time Frame: 12 months follow-up interval
Gingival health:
Measuring device: Gingival index \& Bleeding on probing (BOP) Measuring unit: (scores).
Measured: 12 months follow-up interval
Secondary outcomes (1)
patient satisfaction by Visual analogue Scale (VAS)
Numerical (0) unsatisfied (10) satisfied
Measured: 12 months follow-up interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Behavior of ZLS and UTMLStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Almudahka, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521501
- Sponsor's protocol ID
- 10 7 25
- Status last verified
- Sep 2025
- First submitted
- 5 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07521501
- Acronym / sponsor ID
- 10 7 25
- Conditions
- Clinical Behavior of ZLS and UTML
- Keywords
- KATANA (UTML zirconia), AMBRIA (zirconia reinforced glass ceramic), clinical behavior, patient satisfaction, conservative marginal design
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
The aim of the present study is to evaluate clinical behavior and patient satisfaction of Zirconia-reinforced lithium disilicate press ceramic crowns when used in a conservative marginal design(0.6mm chamfer finish line). Comparison with Ultratranslucent multilayered monolithic zirconiacrowns will also be carried out in terms of marginal integrity, fracture, color stability and gingival health for 12 month
Detailed description
- Select and examine patients based on inclusion/exclusion criteria, then obtain consent.
- Diagnose chief complaint, assess teeth in the esthetic zone, and perform scaling/polishing.
- Take primary impressions for study casts.
- Instruct patients to brush three times daily for good oral hygiene.
- Capture pre-op photos and radiographs.
- Choose the appropriate shade.
- Tooth Preparation:
- Group 1: Ultra-translucent zirconia crown (CAD/CAM, 0.6mm chamfer).
- Group 2: Zirconia-reinforced lithium disilicate crown (press, 0.6mm chamfer).
- Perform tissue retraction and take impressions with IOS.
- Create provisional crowns.
- Fabricate crowns (AMBRIA or KATANA zirconia) per manufacturer guidelines.
- Conduct try-in.
- Cement using light-cured resin adhesive.
- Assess restoration at 3, 6, 9 and 12 months for clinical behavior and patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UTML (KATANA) crowns arm | Active comparator | Device: UTML (KATANA) crowns with conservative marginal designPatients will receive ultra-translucent multilayered monolithic zirconia crowns ( KATANA UTML) fabricated using CAD/CAM with conservative marginal design (0.6 mm). |
| ZLS crowns arm | Experimental | Device: ZLS (AMBRIA) crowns with conservative marginal designPatients will receive zirconia-reinforced lithium silicate press ceramic crowns ( VITA Ambria) with conservative marginal design (0.6 mm). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The age range of the patients from 21- 50 years old; able to read and sign the informed consent document; illiterate patients will be avoided.
- Patients who can physically and psychologically tolerate conventional restorative procedures.
- Patients with endodontically treated teeth indicated for ceramic crowns in the esthetic Zone (all axial walls existing).
- Patients with no active periodontal or pulpal diseases.
- Patients with teeth problems indicated for full coverage restoration in the esthetic zone (e.g.
Key exclusion criteria (2 listed)
- 1 Patients with poor oral hygiene and motivation. 2. high caries rate. 3. Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch). 4. Patients suffering from parafunctional habits or temporomandibular disorders.
- 7. Patients with teeth have extensive tooth structure loss, even if one wall is missing.
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 |
|---|---|---|
| UTML (KATANA) crowns with conservative marginal designMonolithic zirconia (KATANA UTML) crown fabricated with CAD/CAM and a conservative 0.6 mm marginal design. | Device | UTML (KATANA) crowns arm |
| ZLS (AMBRIA) crowns with conservative marginal designZirconia-reinforced lithium silicate press ceramic (Ambria) crown with conservative 0.6 mm marginal design. | Device | ZLS crowns arm |
Primary outcome
clinical behavior
Time frame: 12 months follow-up interval
Marginal integrity: Measuring device: Modified USPHS criteria. Measuring unit: Discrete (scores).
Fracture:
Time frame: Time Frame: 12 months follow-up interval.
Description: Measuring device: Modified USPHS criteria Measuring unit: Discrete (scores).
Color stability:
Time frame: Time Frame: 12 months follow-up interval
Description: Measuring device: Spectrophotometer Measuring unit: ΔE.
Gingival health:
Time frame: 12 months follow-up interval
Measuring device: Gingival index \& Bleeding on probing (BOP) Measuring unit: (scores).
1 secondary outcome
patient satisfaction by Visual analogue Scale (VAS)
Time frame: 12 months follow-up interval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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.
Questions about this trial
What is this clinical trial studying?
A study testing UTML (KATANA) crowns with conservative marginal design and ZLS (AMBRIA) crowns with conservative marginal design in people with Clinical Behavior of ZLS and UTML, run by Cairo University.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanan Ibrahim AL-Mudahka (00201044511118/ 0097455466442, hanan.almudahka@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical behavior (time frame: 12 months follow-up interval). The study lists 4 primary outcomes in all. 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 13 Apr 2026.