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Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia

Primary Purpose

Broken Tooth With Complication, Non Vital Teeth, Mutilated Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Veneered zirconia
Monolithic zirconia
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Broken Tooth With Complication focused on measuring mutilated, root canal treated teeth, and coronal fracture

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
  2. Patients able physically and psychologically to tolerate conventional restorative procedures.
  3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
  4. Patients with teeth problems indicated for full coverage restoration (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
  5. Patients with root canal treated teeth requiring full coverage restorations.
  6. Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

  1. Patients in the growth stage with partially erupted teeth.
  2. Patients with poor oral hygiene and motivation.
  3. A pregnant woman's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
  4. Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle bunch).
  5. Patients have no opposite occluding dentition in the area intended for restoration.
  6. Patients suffer from Para functional habits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    veneered zirconia full coverage restorations

    Monolithic zirconia full coverage restorations

    Arm Description

    InCoris zirconia material (TZI-Densupply sirona)

    InCoris (TZI-Densupply sirona)

    Outcomes

    Primary Outcome Measures

    Chipping
    chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.

    Secondary Outcome Measures

    tooth wear
    Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.

    Full Information

    First Posted
    September 15, 2017
    Last Updated
    September 24, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03295513
    Brief Title
    Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia
    Official Title
    Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (Randomized Controlled Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2017 (Anticipated)
    Primary Completion Date
    December 1, 2018 (Anticipated)
    Study Completion Date
    February 1, 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
    The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing to monolithic zirconia compared to veneered zirconia restoration.
    Detailed Description
    While increase using of zirconia in extra coronal restoration as a substitute for metal ceramic restoration still high rate of technical complications specifically chipping of veneering ceramic and wear of antagonist are usually associated with veneered zirconia restoration which led to development of new monolithic zirconia to overcome these technical complications. Therefore this study will be conducted to evaluate chipping and wear of antagonist of veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area. Benefits of the research to the patient: Patient will receive a restoration with superior function, esthetics, and quality. It will save teeth such as mutilated teeth, endodontically treated and teeth with massive loss of tooth structure that cannot be restored with direct restoration. As a result of properly functioning restoration, teeth will be restored with predictable prognosis and the patient will be psychologically improved. Benefits of the research to the clinician: Practitioner will have the advantage to clinically assess a new material that can be used in different situations for better function and esthetic outcomes. It will improve patient confidence with the dentist. Explanation for choice of comparators: The use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia. A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D= 2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis reported Alpha scores greater than 95% indicating no predictable changes during the 5 years Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and 70% reported bravo after 3 years of clinical use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Broken Tooth With Complication, Non Vital Teeth, Mutilated Teeth
    Keywords
    mutilated, root canal treated teeth, and coronal fracture

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patient will receive a restoration with superior function, esthetics, and quality.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    veneered zirconia full coverage restorations
    Arm Type
    Active Comparator
    Arm Description
    InCoris zirconia material (TZI-Densupply sirona)
    Arm Title
    Monolithic zirconia full coverage restorations
    Arm Type
    Experimental
    Arm Description
    InCoris (TZI-Densupply sirona)
    Intervention Type
    Other
    Intervention Name(s)
    Veneered zirconia
    Intervention Description
    he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia
    Intervention Type
    Other
    Intervention Name(s)
    Monolithic zirconia
    Intervention Description
    Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced
    Primary Outcome Measure Information:
    Title
    Chipping
    Description
    chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
    Time Frame
    12 month
    Secondary Outcome Measure Information:
    Title
    tooth wear
    Description
    Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age range of the patients from 20-60 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 (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth). Patients with root canal treated teeth requiring full coverage restorations. 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. A pregnant woman'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 (patient that has phobia from dental treatments or needle bunch). Patients have no opposite occluding dentition in the area intended for restoration. Patients suffer from Para functional habits.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nouran M Ibrahim
    Phone
    01149928886
    Ext
    +20
    Email
    nouran.mahmoud@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia

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