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Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols

Primary Purpose

Natural Optical Properties

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polished celtra press full coverage crown
glazed celtra press full coverage crowns
contralateral natural teeth
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Natural Optical Properties focused on measuring celtra press

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range of the patients from 20-45 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 with contralatral tooth not filled or fractured.
  • Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene and motivation.
  • Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
  • Patients with psychiatric problems or unrealistic expectation
  • Deep discoloration of abutment .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    polished celtra press full coverage crowns

    glazed celtra press full coverage crowns

    contralateral natural teeth

    Arm Description

    a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing

    a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing

    the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth

    Outcomes

    Primary Outcome Measures

    color match
    Color match will be measured using "United states pulplic health service " system . Scale system : Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade Charlie : Obvious mismatch, beyond the normal range Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence

    Secondary Outcome Measures

    Color difference
    The color difference (ΔE) will be measured using spectrophotometer

    Full Information

    First Posted
    January 17, 2019
    Last Updated
    March 1, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813628
    Brief Title
    Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols
    Official Title
    Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Zirconia Reinforced Lithium Silicate Ceramics "Celtra Press" Treated With Different Surface Finishing Protocols.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (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
    investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic).
    Detailed Description
    Two groups of patients will be selected according to special inclusion criteria N=5 in each group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of the same material , after crowns delivery color difference (ΔE) between the natural teeth and the celtra press crown will be measured by a spectrophotometer device (intra oral) and patient satisfaction will be recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Natural Optical Properties
    Keywords
    celtra press

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    polished celtra press full coverage crowns
    Arm Type
    Experimental
    Arm Description
    a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
    Arm Title
    glazed celtra press full coverage crowns
    Arm Type
    Experimental
    Arm Description
    a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
    Arm Title
    contralateral natural teeth
    Arm Type
    Active Comparator
    Arm Description
    the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth
    Intervention Type
    Other
    Intervention Name(s)
    polished celtra press full coverage crown
    Other Intervention Name(s)
    polished all ceramic crown
    Intervention Description
    a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
    Intervention Type
    Other
    Intervention Name(s)
    glazed celtra press full coverage crowns
    Other Intervention Name(s)
    glazed all ceramic crown
    Intervention Description
    a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
    Intervention Type
    Other
    Intervention Name(s)
    contralateral natural teeth
    Intervention Description
    the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth
    Primary Outcome Measure Information:
    Title
    color match
    Description
    Color match will be measured using "United states pulplic health service " system . Scale system : Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade Charlie : Obvious mismatch, beyond the normal range Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence
    Time Frame
    immediately after crown delivery
    Secondary Outcome Measure Information:
    Title
    Color difference
    Description
    The color difference (ΔE) will be measured using spectrophotometer
    Time Frame
    immediately after crown delivery
    Other Pre-specified Outcome Measures:
    Title
    patient satisfaction
    Description
    Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
    Time Frame
    immediately after crown delivery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age range of the patients from 20-45 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 with contralatral tooth not filled or fractured. Patients willing to return for follow-up examinations and evaluation. Exclusion Criteria: Patients in the growth stage with partially erupted teeth. Patients with poor oral hygiene and motivation. Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution. Patients with psychiatric problems or unrealistic expectation Deep discoloration of abutment .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nourhan sayed
    Phone
    01117911384
    Email
    nourhan.sayed@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols

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