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One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Primary Purpose

Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioHPP PEEK-based single posterior crowns
Metal ceramic single posterior crowns
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Single Posterior Crowns

Eligibility Criteria

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

Inclusion Criteria:

  1. From 18-50 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. Patients with teeth problems indicated for single posterior crowns:

    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 posterior teeth
  5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

  1. Patient less than 18 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. Lack of opposing dentition in the area of interest

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Metal ceramic single posterior crowns

    BioHPP PEEK-based single posterior crowns

    Arm Description

    Metal copings veneered with feldspathic porcelain

    BioHPP PEEK copings veneered with composite resin

    Outcomes

    Primary Outcome Measures

    Fracture
    Measured using modified USPHS criteria

    Secondary Outcome Measures

    Marginal adaptation
    Measured using modified USPHS criteria

    Full Information

    First Posted
    September 25, 2018
    Last Updated
    September 25, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03685513
    Brief Title
    One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
    Official Title
    One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (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 the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK. BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin. The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Metal ceramic single posterior crowns
    Arm Type
    Active Comparator
    Arm Description
    Metal copings veneered with feldspathic porcelain
    Arm Title
    BioHPP PEEK-based single posterior crowns
    Arm Type
    Experimental
    Arm Description
    BioHPP PEEK copings veneered with composite resin
    Intervention Type
    Other
    Intervention Name(s)
    BioHPP PEEK-based single posterior crowns
    Intervention Description
    BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
    Intervention Type
    Other
    Intervention Name(s)
    Metal ceramic single posterior crowns
    Other Intervention Name(s)
    Porcelain fused to metal (PFM) or Ceramo-metallic
    Intervention Description
    Standard metal coping veneered with glass ceramics
    Primary Outcome Measure Information:
    Title
    Fracture
    Description
    Measured using modified USPHS criteria
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Marginal adaptation
    Description
    Measured using modified USPHS criteria
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Patient Satisfaction
    Description
    Measured using modified USPHS criteria
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: From 18-50 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 Patients with teeth problems indicated for single posterior crowns: Badly decayed teeth Teeth restored with large filling restorations Endodontically treated teeth Malformed teeth Malposed teeth (Tilted, over-erupted, rotated, etc.) Spacing between posterior teeth Able to return for follow-up examinations and evaluation Exclusion Criteria: Patient less than 18 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 Lack of opposing dentition in the area of interest
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelrahman Badran, M.D.s
    Phone
    01007029340
    Email
    asbadran77@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amina Zaki

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

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