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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03685513
Collaborator
(none)
46
Enrollment
2
Arms
17
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: BioHPP PEEK-based single posterior crowns
  • Other: Metal ceramic single posterior crowns
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose:
Treatment
Official Title:
One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Metal ceramic single posterior crowns

Metal copings veneered with feldspathic porcelain

Other: Metal ceramic single posterior crowns
Standard metal coping veneered with glass ceramics
Other Names:
  • Porcelain fused to metal (PFM) or Ceramo-metallic

    		•
    Experimental: BioHPP PEEK-based single posterior crowns

    BioHPP PEEK copings veneered with composite resin

    Other: BioHPP PEEK-based single posterior crowns
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Fracture [1 year]

      Measured using modified USPHS criteria

    Secondary Outcome Measures

    1. Marginal adaptation [1 year]

      Measured using modified USPHS criteria

    Other Outcome Measures

    1. Patient Satisfaction [1 year]

      Measured using modified USPHS criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    5. Badly decayed teeth

    6. Teeth restored with large filling restorations

    7. Endodontically treated teeth

    8. Malformed teeth

    9. Malposed teeth (Tilted, over-erupted, rotated, etc.)

    10. Spacing between posterior teeth

    11. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdelrahman Soliman Elsayed Badran, Resident, Fixed Prosthodontics Department, Faculty of Dentistry, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03685513
    Other Study ID Numbers:
    • CEBD-CU-2018-09-30
    First Posted:
    Sep 26, 2018
    Last Update Posted:
    Sep 26, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tooth, Nonvital
    Dental Caries

    Study Results

    No Results Posted as of Sep 26, 2018