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Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life

Primary Purpose

Partially Edentulous Mandible

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peek telescopic partial denture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partially Edentulous Mandible

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - Kennedy Class I Partially edentulous patients.
  • Patients with good oral hygiene.
  • The distal abutment bilaterally should be a premolar.
  • Abutment teeth should be in a good periodontal condition.
  • Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment.
  • There should be no modifications spaces in the arch to be treated, and if found it should be treated with a fixed partial denture first.
  • Normal tongue size
  • Medically free from any disease that might affect bone support
  • Patients with no history of bad oral habits as (Bruxism or Clenching) and free from any T.M.J disorders.

Exclusion Criteria:

  • Patients with bad oral hygiene.
  • Teeth with severe malalignment.
  • The arch to be treated is opposed by a completely edentulous arch.
  • Unmotivated patient.
  • Patient with a medical disease that will hinder his ability to be committed to the treatment.
  • Patients on a radiation therapy.
  • Patients with xerostomia.
  • Patients with a history of drug, alcohol abuse or psychiatric disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Co-cr telescopic partial denture

    PEEK telescopic partial denture

    Arm Description

    A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium

    A removable partial denture, its attachment is a telescopic crown made of PEEK

    Outcomes

    Primary Outcome Measures

    oral health impact profile
    questionnaire

    Secondary Outcome Measures

    probing depth of abutment teeth
    using williams graduated probe
    abutment mobility
    millers classification

    Full Information

    First Posted
    December 5, 2018
    Last Updated
    December 10, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03771248
    Brief Title
    Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life
    Official Title
    A Comparison Between Polyetheretherketone and Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Partially Edentulous Patients Regarding Oral Health Related Quality of Life (A Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    July 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

    5. Study Description

    Brief Summary
    Dentistry is a rapidly progressing field with innumerable advances taking place on a day to day basis. The application of newer technologies and materials has advanced the specialty of prosthodontics and the services rendered to the patients. Taking into consideration that PEEK as a material wasn't clinically investigated to be used as a material for routine use, however PEEK in removable partial dentures will help in making many steps easier and reach patients demands regarding esthetics. Also, owing to the superior mechanical and biological properties of PEEK, it will not be surprising if dentures constructed from the polymer are routinely constructed in near future.
    Detailed Description
    On fabrication of telescopic removable partial denture, choosing the material is a major step in the success of the treatment. There are different aspects that should be taken into consideration while choosing it. Beginning with retention as it is a crucial aspect. The retention of the telescopic partial denture is gained from the friction between the primary and secondary crowns. The chosen material should be able to maintain this type of retention for the longest possible period. The esthetics also affects the treatment choice and patients preference, patients would choose metal free restorations over the ones that display metal. Finally the load distribution between the residual ridge and abutment should be equalized and transmitted in a favorable way. Otherwise one of the following consequences will occur; either overload on the abutment teeth followed by bone loss and abutment mobility or this overload is on the residual ridge leading to fast, progressive bone loss. Cobalt chromium that is used for fabricating the telescopic removable partial denture is considered that most suitable material up till this moment. However, it doesn't fulfill much of the previous points. As there will always be a continued improvement of materials and techniques used in dentistry especially in prosthodontics, innovative techniques must be regarded as potential alternatives to traditional materials. PEEK is from the innovative materials that has shown promising results in different branches. However, to date no clinical studies or systematic reviews focusing on the use of PEEK dentures have been published, therefore more investigations are needed in this field.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Partially Edentulous Mandible

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Co-cr telescopic partial denture
    Arm Type
    Active Comparator
    Arm Description
    A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium
    Arm Title
    PEEK telescopic partial denture
    Arm Type
    Experimental
    Arm Description
    A removable partial denture, its attachment is a telescopic crown made of PEEK
    Intervention Type
    Device
    Intervention Name(s)
    peek telescopic partial denture
    Intervention Description
    removable partial denture
    Primary Outcome Measure Information:
    Title
    oral health impact profile
    Description
    questionnaire
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    probing depth of abutment teeth
    Description
    using williams graduated probe
    Time Frame
    12 months
    Title
    abutment mobility
    Description
    millers classification
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Kennedy Class I Partially edentulous patients. Patients with good oral hygiene. The distal abutment bilaterally should be a premolar. Abutment teeth should be in a good periodontal condition. Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment. There should be no modifications spaces in the arch to be treated, and if found it should be treated with a fixed partial denture first. Normal tongue size Medically free from any disease that might affect bone support Patients with no history of bad oral habits as (Bruxism or Clenching) and free from any T.M.J disorders. Exclusion Criteria: Patients with bad oral hygiene. Teeth with severe malalignment. The arch to be treated is opposed by a completely edentulous arch. Unmotivated patient. Patient with a medical disease that will hinder his ability to be committed to the treatment. Patients on a radiation therapy. Patients with xerostomia. Patients with a history of drug, alcohol abuse or psychiatric disorder.

    12. IPD Sharing Statement

    Learn more about this trial

    Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life

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