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Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

Primary Purpose

Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioHPP PEEK copings veneered with composite resin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth

Eligibility Criteria

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

Inclusion Criteria:

  • From 18-50 years old, be able to read and sign the informed consent document.
  • Patient Have no active periodontal or pulpal diseases, have teeth with good restorations
  • Patient Psychologically and physically able to withstand conventional dental procedures
  • Patients with teeth problems indicated for single posterior crowns:

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
  • Patients in the growth stage with partially erupted teeth
  • Patient with Psychiatric problems or unrealistic expectations
  • Patient with 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

    Zirconia single posterior crowns veneered with ceramics

    BioHpp PEEK single posterior crowns veneered with compos

    Arm Description

    'In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits

    In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits

    Outcomes

    Primary Outcome Measures

    Internal fit of the crown by measuring the thickness of the replica by steriomicroscope
    measured by replica technique and steriomicroscope

    Secondary Outcome Measures

    secondary caries if present at the margin of the crown by using probe
    Measured by modified Ryge criteria Alpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but notAlpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins). directly associated with cavosurface margins).

    Full Information

    First Posted
    August 4, 2019
    Last Updated
    August 12, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04052789
    Brief Title
    Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
    Official Title
    Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    August 1, 2020 (Anticipated)
    Study Completion Date
    August 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
    All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. The success of dental restorations is determined by four main factors: biocompatibility, aesthetic value, resistance to fracture and marginal adaptation. . An inadequate marginal fit may compromise the longevity of the restoration since cement film exposure to the oral environment can lead to its dissolution . . Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce. Aim of the study: - The aim of this study is to evaluate the internal fit of milled BioHPP PEEK-based versus zirconia-based single crowns.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    Double(participant, outcome Assessor) Double blind
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zirconia single posterior crowns veneered with ceramics
    Arm Type
    Active Comparator
    Arm Description
    'In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits
    Arm Title
    BioHpp PEEK single posterior crowns veneered with compos
    Arm Type
    Experimental
    Arm Description
    In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits
    Intervention Type
    Other
    Intervention Name(s)
    BioHPP PEEK copings veneered with composite resin
    Intervention Description
    In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits . Participant patients will be asked about any problems they are having. Patients will be recalled every two months for one year for follow up visits.
    Primary Outcome Measure Information:
    Title
    Internal fit of the crown by measuring the thickness of the replica by steriomicroscope
    Description
    measured by replica technique and steriomicroscope
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    secondary caries if present at the margin of the crown by using probe
    Description
    Measured by modified Ryge criteria Alpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but notAlpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins). directly associated with cavosurface margins).
    Time Frame
    one year
    Other Pre-specified Outcome Measures:
    Title
    patient satisfaction
    Description
    Measured by VAS(questionnaire)Numerical (discrete) ("0" unsatisfied - "10" satisfied)
    Time Frame
    one 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. Patient Have no active periodontal or pulpal diseases, have teeth with good restorations Patient Psychologically and physically able to withstand conventional dental procedures Patients with teeth problems indicated for single posterior crowns: 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 Patients in the growth stage with partially erupted teeth Patient with Psychiatric problems or unrealistic expectations Patient with Lack of opposing dentition in the area of interest
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nahla Adly, M.D.S
    Phone
    01010604355
    Email
    Dr.nahla.81@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amina Zaki, professor
    Email
    aazaki99@yahoo.co.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

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