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Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics

Primary Purpose

Tooth Loss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
poly ether ketone ketone
lithium disilicate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Zirconia implants, PEKK crowns, high performance polymer crowns

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age >18 years
  • No active intraoral or systemic disease
  • No pregnancy or lactation
  • controlled periodontal conditions
  • Adequate bone volume to place an implant
  • Occlusal function with a natural tooth

Exclusion Criteria:

  1. Current pregnancy.
  2. Psychiatric disorders.
  3. Smokers
  4. Poor motivation.
  5. Several occlusal parafunction.
  6. Persistent intraoral infections.
  7. Severe mucosal disease.
  8. Active periodontitis.
  9. Poor oral hygiene.
  10. Lack of occluding dentition at implant rehabilitation level

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    lithium disilicate crowns

    poly ether ketone ketone crowns

    Arm Description

    lithium disilicate crowns are well documented in the literatures as successful restoration modality.

    pekkton

    Outcomes

    Primary Outcome Measures

    Esthetic outcome
    measured by pink and white esthetics score

    Secondary Outcome Measures

    bone resorption
    measured by CBCT and measuring unit Housfield Unit(HU)

    Full Information

    First Posted
    April 26, 2018
    Last Updated
    May 8, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03521024
    Brief Title
    Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics
    Official Title
    Evaluation of Esthetic and Biomechanical Outcome of Maxillary Anterior Single-Tooth Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on PEKK Abutments: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2018 (Anticipated)
    Primary Completion Date
    June 15, 2019 (Anticipated)
    Study Completion Date
    September 15, 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

    5. Study Description

    Brief Summary
    aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments .
    Detailed Description
    High performance polymers may be a valid alternative to other conventional materials for abutments and crowns over zirconia implants because of their cushioning effect and elastic modulus (5.1GPa), which absorb occlusal forces and avoid overload of the underlying bone from the direct transmission of biting impacts ; which could optimize and preserve osseointegration with time. Zirconia implants with high performance polymers restorations can be considered a good alternative for replacing natural teeth. For many years lithium disilicate has been the esthetics standard used in Veneers ,Inlays , onlays, occlusal veneers, partial crowns,minimally invasive crowns and Implant superstructures due to its natural-looking tooth colouring and excellent light-optical properties. Due to the promising esthetics of high performance polymers as it can be veneered with different veneering materials it would successfully restore esthetics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Loss
    Keywords
    Zirconia implants, PEKK crowns, high performance polymer crowns

    7. Study Design

    Primary Purpose
    Treatment
    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
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    lithium disilicate crowns
    Arm Type
    Active Comparator
    Arm Description
    lithium disilicate crowns are well documented in the literatures as successful restoration modality.
    Arm Title
    poly ether ketone ketone crowns
    Arm Type
    Experimental
    Arm Description
    pekkton
    Intervention Type
    Other
    Intervention Name(s)
    poly ether ketone ketone
    Intervention Description
    Polyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials
    Intervention Type
    Other
    Intervention Name(s)
    lithium disilicate
    Intervention Description
    well documented in the literatures as successful restoration modality.
    Primary Outcome Measure Information:
    Title
    Esthetic outcome
    Description
    measured by pink and white esthetics score
    Time Frame
    9 month
    Secondary Outcome Measure Information:
    Title
    bone resorption
    Description
    measured by CBCT and measuring unit Housfield Unit(HU)
    Time Frame
    9 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age >18 years No active intraoral or systemic disease No pregnancy or lactation controlled periodontal conditions Adequate bone volume to place an implant Occlusal function with a natural tooth Exclusion Criteria: Current pregnancy. Psychiatric disorders. Smokers Poor motivation. Several occlusal parafunction. Persistent intraoral infections. Severe mucosal disease. Active periodontitis. Poor oral hygiene. Lack of occluding dentition at implant rehabilitation level
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    lamiaa Abdelsalam, MSc
    Phone
    201015833015
    Email
    dr.l.fadaly@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lamiaa Abdelsalam, MSc
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics

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