NCT07521501

Brief 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). 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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 13, 2026

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

March 5, 2026

Last Update Submit

April 8, 2026

Conditions

Clinical Behavior of ZLS and UTML

Keywords

KATANA (UTML zirconia)AMBRIA (zirconia reinforced glass ceramic)clinical behaviorpatient satisfactionconservative marginal design

Outcome Measures

Primary Outcomes (4)

  • clinical behavior

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

    12 months follow-up interval

  • Fracture:

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

    Time Frame: 12 months follow-up interval.

  • Color stability:

    Description: Measuring device: Spectrophotometer Measuring unit: ΔE.

    Time Frame: 12 months follow-up interval

  • Gingival health:

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

    12 months follow-up interval

Secondary Outcomes (1)

  • patient satisfaction by Visual analogue Scale (VAS)

    12 months follow-up interval

Study Arms (2)

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).

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).

Device: ZLS (AMBRIA) crowns with conservative marginal design

Interventions

UTML (KATANA) crowns with conservative marginal designDEVICE

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

UTML (KATANA) crowns arm
ZLS (AMBRIA) crowns with conservative marginal designDEVICE

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

ZLS crowns arm

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Crowns

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Central Study Contacts

Hanan Ibrahim AL-Mudahka

CONTACT

00201044511118/ 0097455466442hanan.almudahka@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2026

First Posted

April 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 13, 2026

Record last verified: 2025-09