- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521501
Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design
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)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanan Ibrahim AL-Mudahka
- Phone Number: 00201044511118/ 0097455466442
- Email: hanan.almudahka@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: UTML (KATANA) crowns arm
Patients will receive ultra-translucent multilayered monolithic zirconia crowns ( KATANA UTML) fabricated using CAD/CAM with conservative marginal design (0.6 mm).
|
Monolithic zirconia (KATANA UTML) crown fabricated with CAD/CAM and a conservative 0.6 mm marginal design.
|
|
Experimental: ZLS crowns arm
Patients will receive zirconia-reinforced lithium silicate press ceramic crowns ( VITA Ambria) with conservative marginal design (0.6 mm).
|
Zirconia-reinforced lithium silicate press ceramic (Ambria) crown with conservative 0.6 mm marginal design.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical behavior
Time Frame: 12 months follow-up interval
|
Marginal integrity: Measuring device: Modified USPHS criteria. Measuring unit: Discrete (scores). |
12 months follow-up interval
|
|
Fracture:
Time Frame: Time Frame: 12 months follow-up interval.
|
Description: Measuring device: Modified USPHS criteria Measuring unit: Discrete (scores).
|
Time Frame: 12 months follow-up interval.
|
|
Color stability:
Time Frame: Time Frame: 12 months follow-up interval
|
Description: Measuring device: Spectrophotometer Measuring unit: ΔE.
|
Time Frame: 12 months follow-up interval
|
|
Gingival health:
Time Frame: 12 months follow-up interval
|
Measuring device: Gingival index & Bleeding on probing (BOP) Measuring unit: (scores).
|
12 months follow-up interval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient satisfaction by Visual analogue Scale (VAS)
Time Frame: 12 months follow-up interval
|
Numerical (0) unsatisfied (10) satisfied
|
12 months follow-up interval
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10 7 25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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