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Not yet recruiting NCT07521501

Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design

No phase Interventional Clinical Behavior of ZLS and UTML

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UTML (KATANA) crowns with conservative marginal design, ZLS (AMBRIA) crowns with conservative marginal design.
Who it may be relevant to
Registry conditions: Clinical Behavior of ZLS and UTML. Basic parameters: 21 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

Interventions

  • Device UTML (KATANA) crowns with conservative marginal design
    Monolithic zirconia (KATANA UTML) crown fabricated with CAD/CAM and a conservative 0.6 mm marginal design.
  • Device ZLS (AMBRIA) crowns with conservative marginal design
    Zirconia-reinforced lithium silicate press ceramic (Ambria) crown with conservative 0.6 mm marginal design.

Primary outcome measures

  • clinical behavior [Time frame: 12 months follow-up interval]
  • Fracture: [Time frame: Time Frame: 12 months follow-up interval.]
  • Color stability: [Time frame: Time Frame: 12 months follow-up interval]
  • Gingival health: [Time frame: 12 months follow-up interval]
Secondary outcome measures (1)
  • patient satisfaction by Visual analogue Scale (VAS) [Time frame: 12 months follow-up interval]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07521501 · 10 7 25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗