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
Primary Purpose
Decayed Teeth, Malposed Teeth, Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lithium disilicate (IPS e-max) ceramic crown
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown
natural tooth
Sponsored by
About this trial
This is an interventional treatment trial for Decayed Teeth
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
natural tooth
lithium disilicate (IPS e-max) ceramic crown
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown
Arm Description
monolithic lithium disilicate (IPS e-max) ceramic crown for crowns in esthetic zone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Shade match
measured by Vita Easyshade V spectrophotometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04738526
Brief Title
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
Official Title
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 (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Restorative dentistry is a mix of science and art. The success of restorative dentistry is determined on the basis of functional and esthetic results. Closely matching natural teeth with an artificial restoration can be one of the most challenging procedures in restorative dentistry. Natural teeth vary greatly in color and shape.The color of a ceramic restoration is affected by the shade of the ceramic material, its thickness, and, the color of the underlying material. The restoration's color is influenced by ceramic firing temperature, the color of the prepared tooth, translucency and thickness of veneering porcelain.
The rational of this study is newly introduced gradient technology zirconia (5Y-TZP\3Y-TZP) (IPS e.max Zircad Prime) with improved optical properties to solve the drawbacks of esthetic properties of zirconia.
Null hypothesis of the study will be:
There would be no difference in shade matching of the new gradient technology zirconia (5Y-TZP\3Y-TZP) and lithium disilicate ceramic crowns used in the esthetic zone.
There would be no difference in patient satisfaction of new gradient technology zirconia (5Y-TZP\3Y-TZP) and lithium disilicate ceramic crowns at baseline, 3, 6, 9, 12 months used in the esthetic zone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decayed Teeth, Malposed Teeth, Endodontically Treated Teeth, Teeth Restored With Large Filling Restorations, Single Anterior Crowns, Single Premolars Crowns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
natural tooth
Arm Type
Active Comparator
Arm Title
lithium disilicate (IPS e-max) ceramic crown
Arm Type
Experimental
Arm Description
monolithic lithium disilicate (IPS e-max) ceramic crown for crowns in esthetic zone
Arm Title
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
lithium disilicate (IPS e-max) ceramic crown
Intervention Description
monolithic lithium disilicate ceramic crown
Intervention Type
Other
Intervention Name(s)
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
natural tooth
Intervention Description
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
Primary Outcome Measure Information:
Title
shade match
Description
measured by Modified United States Public Health Service criteria (USPHS criteria) Score Alpha(A):matches tooth Bravo(B):acceptable mismatch Charlie(C):unacceptable mismatch
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Shade match
Description
measured by Vita Easyshade V spectrophotometer
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
measured by Visual Analog Scale Questionnaire (VAS Questionnaire) ("0" unsatisfied - "10" satisfied)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha Khaled Eid, M.D.s
Phone
01223976400
Email
noha.khaled@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Mahmoud sherif, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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