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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decayed Teeth

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. From 21-50 years old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations.
  3. Psychologically and physically able to withstand conventional dental procedures.
  4. Patient with thick gingival biotype.
  5. Patients with teeth problems indicated for single all ceramic restoration in esthetic zone

    1. Badly decayed teeth.
    2. Teeth restored with large filling restorations.
    3. Endodontically treated teeth.
    4. Malformed teeth.
    5. Malposed teeth (Tilted, over-erupted, rotated, etc.).
    6. Spacing between teeth in esthetic zone.
  6. Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

  1. Patient less than 21 or more than 50 years.
  2. Patient with active resistant periodontal diseases.
  3. Patients with poor oral hygiene and uncooperative patients.
  4. Pregnant women.
  5. Patients in the growth stage with partially erupted teeth.
  6. Psychiatric problems or unrealistic expectations.
  7. Patient with periodontal problems.
  8. 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

    First Posted
    January 31, 2021
    Last Updated
    February 3, 2021
    Sponsor
    Cairo University
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    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

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    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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