NCT06539546

Brief Summary

The aim of the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

July 29, 2024

Last Update Submit

August 7, 2024

Conditions

Mutilated TeethEndodontically Treated Teeth

Keywords

Shade matchpatient satisfactionYttria stabilized multilayered zirconiaLithium disilicate

Outcome Measures

Primary Outcomes (1)

  • Color difference

    By Intraoral Spectrophotometer, color difference between the restoration and the adjacent or contralateral natural tooth will be measured by the unit (ΔE), (ΔE) will be measured for each sample.

    immediate after cementation

Secondary Outcomes (1)

  • Patient satisfaction

    immediate after cementation

Study Arms (2)

Yttria stabilized multilayered (YML) zirconia restorations

EXPERIMENTAL

Full coverage Yttria stabilized multilayered (YML) zirconia restorations will be fabricated on a tooth requiring full coverage in the esthetic zone.

Other: Yttria stabilized multilayered (YML) zirconia restorations

Lithium disilicate restorations

EXPERIMENTAL

Full coverage Lithium disilicate restorations will be fabricated on a tooth requiring full coverage in the esthetic zone.

Other: Lithium disilicate restorations

Interventions

Yttria stabilized multilayered (YML) zirconia restorationsOTHER

Yttria stabilized multilayered zirconia restorations were claimed to have high strength and esthetics at the same time but no clinical studies were conducted yet to prove its high esthetic properties

Yttria stabilized multilayered (YML) zirconia restorations
Lithium disilicate restorationsOTHER

Lithium disilicate reinforced glass ceramics are considered a gold standard for monolithic esthetic restorations.

Lithium disilicate restorations

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
  • Patients able physically and psychologically to tolerate conventional restorative procedures.
  • Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
  • Patients with teeth problems indicated for full coverage restoration (coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
  • Patients with root canal treated teeth requiring full coverage restorations.
  • Patients willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene and motivation.
  • Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch).
  • Patients suffer from parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth, NonvitalPatient Satisfaction

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Yasmin Mohamed ElFiky

CONTACT

1000298446Yasmin_mohamed@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

July 29, 2024

First Posted

August 6, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08