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NCT Number: NCT07521501

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

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

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • Patients with teeth have extensive tooth structure loss, even if one wall is missing.

Treatment and study plan

UTML (KATANA) crowns with conservative marginal design

Device

Monolithic zirconia (KATANA UTML) crown fabricated with CAD/CAM and a conservative 0.6 mm marginal design.

ZLS (AMBRIA) crowns with conservative marginal design

Device

Zirconia-reinforced lithium silicate press ceramic (Ambria) crown with conservative 0.6 mm marginal design.

Primary outcomes

  1. clinical behavior

    Time frame: 12 months follow-up interval

    Marginal integrity:

    Measuring device: Modified USPHS criteria. Measuring unit: Discrete (scores).

  2. Fracture:

    Time frame: Time Frame: 12 months follow-up interval.

    Description: Measuring device: Modified USPHS criteria Measuring unit: Discrete (scores).

  3. Color stability:

    Time frame: Time Frame: 12 months follow-up interval

    Description: Measuring device: Spectrophotometer Measuring unit: ΔE.

  4. Gingival health:

    Time frame: 12 months follow-up interval

    Measuring device: Gingival index & Bleeding on probing (BOP) Measuring unit: (scores).

Secondary outcomes

  1. patient satisfaction by Visual analogue Scale (VAS)

    Time frame: 12 months follow-up interval

    Numerical (0) unsatisfied (10) satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Hanan Ibrahim AL-Mudahka

CONTACT

[email protected]

00201044511118/ 0097455466442

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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