NCT04738526

Brief Summary

Although zirconia is widely used for fabrication of restorations, the 3Y-TZP zirconia where limited for posterior region for its high strength and bad esthetic. While the 5Y-TZP zirconia is limited for the anterior region due to its good esthetic and low strength. For that reason, the introduction of the new gradient technology zirconia (5Y-TZP\\3Y-TZP) (IPS e.max Zircad Prime) has offered a solution to solve this problem be combining the esthetic of 5Y-TZP and the high strength of 3Y-TZP. The aim of the present study is to evaluate shade matching to natural tooth and patient satisfaction of the new gradient technology zirconia (5Y-TZP\\3Y-TZP) and lithium disilicate ceramic crowns.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Status
unknown

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

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 31, 2021

Last Update Submit

February 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • shade match

    measured by Modified United States Public Health Service criteria (USPHS criteria) Score Alpha(A):matches tooth Bravo(B):acceptable mismatch Charlie(C):unacceptable mismatch

    1 year

Secondary Outcomes (1)

  • Shade match

    1 year

Other Outcomes (1)

  • Patient satisfaction

    1 year

Study Arms (3)

natural tooth

ACTIVE COMPARATOR
Other: natural tooth

lithium disilicate (IPS e-max) ceramic crown

EXPERIMENTAL

monolithic lithium disilicate (IPS e-max) ceramic crown for crowns in esthetic zone

Other: lithium disilicate (IPS e-max) ceramic crown

New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown

EXPERIMENTAL
Other: New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown

Interventions

monolithic lithium disilicate ceramic crown

lithium disilicate (IPS e-max) ceramic crown

conjunction with the two zirconium oxide raw materials 3Y-TZP and 5Y-TZP is responsible for producing a continuous, seamless progression of the shade and translucency within the material

New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown

natural tooth is composed of enamel. Enamel is on the surface of every tooth and it has a natural hue of white. However, the underlying dentin layer has a slightly yellowish color. This yellowish hue shows through the enamel in almost everyone

natural tooth

Eligibility Criteria

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

You may qualify if:

  • From 21-50 years old, be able to read and sign the informed consent document.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Psychologically and physically able to withstand conventional dental procedures.
  • Patient with thick gingival biotype.
  • Patients with teeth problems indicated for single all ceramic restoration in esthetic zone
  • Badly decayed teeth.
  • Teeth restored with large filling restorations.
  • Endodontically treated teeth.
  • Malformed teeth.
  • Malposed teeth (Tilted, over-erupted, rotated, etc.).
  • Spacing between teeth in esthetic zone.
  • Able to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patient less than 21 or more than 50 years.
  • Patient with active resistant periodontal diseases.
  • Patients with poor oral hygiene and uncooperative patients.
  • Pregnant women.
  • Patients in the growth stage with partially erupted teeth.
  • Psychiatric problems or unrealistic expectations.
  • Patient with periodontal problems.
  • Patients with malocclusion or parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental CariesTooth, Nonvital

Interventions

lithia disilicate

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Pulp Diseases

Central Study Contacts

Noha Khaled Eid, M.D.s

CONTACT

Rana Mahmoud sherif, professor

CONTACT

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
Teaching assistant

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

February 5, 2021

Record last verified: 2021-02