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Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers

Primary Purpose

Tooth Discoloration, Tooth Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glazed Celtra Duo
IPS Empress CAD
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All subjects are required to be

    1. From 18-50 years old, be able to read and sign the informed consent document.
    2. Physically and psychologically able to tolerate conventional restorative procedures
    3. have no active periodontal or pulpal diseases, have teeth with good restorations
    4. Patients with teeth problems indicated for laminate veneer:

      1. Discoloration
      2. Fracture not involving more than 50% enamel loss
      3. Mild malposition
      4. Diastema
      5. Enamel fluorosis
      6. Stained or defective restorations
    5. Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

  • 1. Patients in the growth stage with partially erupted teeth 2. Patient with fractured teeth of more than 50% enamel loss 3. Patients with poor oral hygiene and motivation 4. Pregnant women's 5. Patient with post and core endodontically treated teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposite occluding dentition in the area intended for restoration 8. Patients involved in contact sports 9. Teeth with deep discoloration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    glazed Celtra Duo

    Glazed IPS Empress CAD

    Arm Description

    zirconia reinforced lithium silicate glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic

    glazed Leucite based glass ceramics ,Its a glass ceramic which is etchable and proved to have good esthetics if used for laminate veneers

    Outcomes

    Primary Outcome Measures

    fracture resistance
    scores

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2017
    Last Updated
    April 29, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03129711
    Brief Title
    Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
    Official Title
    Patient Satisfaction and One Year Clinical Evaluation of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    September 2018 (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

    5. Study Description

    Brief Summary
    The most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic, leucite based and lithium silicate based ceramics) was fracture of the ceramic, Therefore, ceramic materials that have higher fracture resistance, especially for patients suffering from abnormal occlusion, are needed.
    Detailed Description
    IPS Empress CAD is a leucite glass-ceramic of the SiO2-Al2-O3-K2O material systems with leucite crystal ranging from 5 to 10 µm in size. The leucite crystals increase the material strength and interferes with crack propagation, while the fracture energy is absorbed by the crystalline phase. The resistance and flexural strength (160 Mpa) is improved by the difference in the coefficient of thermal expansion between the glass phase and the crystalline phase and the cooling process following sintering phase. CELTRA DUO: is a new generation of glass ceramic material. With the aid of a new manufacturing process, the glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic (ZLS). The material is characterized by a unique homogenous structure with fine grains that provides excellent material quality and consistency, high strength properties and long term performance. In addition, the material offers satisfying processing characteristics which can be milled and polished easily. After milling the restorations are shaded correctly shaded, with no need for crystallization step 10. The milled restorations have a flexural strength of 210 MPa. After stain and glaze firing the restoration will exhibit a flexural strength up to 370 MPa.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Discoloration, Tooth Fractures

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    glazed Celtra Duo
    Arm Type
    Experimental
    Arm Description
    zirconia reinforced lithium silicate glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic
    Arm Title
    Glazed IPS Empress CAD
    Arm Type
    Active Comparator
    Arm Description
    glazed Leucite based glass ceramics ,Its a glass ceramic which is etchable and proved to have good esthetics if used for laminate veneers
    Intervention Type
    Other
    Intervention Name(s)
    glazed Celtra Duo
    Intervention Description
    zirconia reinforced lithium silicate
    Intervention Type
    Other
    Intervention Name(s)
    IPS Empress CAD
    Other Intervention Name(s)
    Leucite based
    Intervention Description
    Standard etchable glass ceramic for laminate veneers
    Primary Outcome Measure Information:
    Title
    fracture resistance
    Description
    scores
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All subjects are required to be From 18-50 years old, be able to read and sign the informed consent document. Physically and psychologically able to tolerate conventional restorative procedures have no active periodontal or pulpal diseases, have teeth with good restorations Patients with teeth problems indicated for laminate veneer: Discoloration Fracture not involving more than 50% enamel loss Mild malposition Diastema Enamel fluorosis Stained or defective restorations Willing to return for follow-up examinations and evaluation Exclusion Criteria: 1. Patients in the growth stage with partially erupted teeth 2. Patient with fractured teeth of more than 50% enamel loss 3. Patients with poor oral hygiene and motivation 4. Pregnant women's 5. Patient with post and core endodontically treated teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposite occluding dentition in the area intended for restoration 8. Patients involved in contact sports 9. Teeth with deep discoloration
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omnia Wafik El mesallamy, MDS
    Phone
    01006595375
    Email
    omniawafik@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jylan El Guindy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers

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