One Year Clinical Evaluation of Shade Matching and Patient Satisfaction of New Gradient Technology Monolithic Zirconia (5Y-TZP\3Y-TZP) Compared to Lithium Disilicate Crowns in Dental Esthetic Zone
1 other identifier
interventional
30
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
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
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFebruary 5, 2021
February 1, 2021
1 year
January 31, 2021
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 COMPARATORlithium disilicate (IPS e-max) ceramic crown
EXPERIMENTALmonolithic lithium disilicate (IPS e-max) ceramic crown for crowns in esthetic zone
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown
EXPERIMENTALInterventions
monolithic lithium disilicate 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
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
Eligibility Criteria
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
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
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