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

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ClinicalTrials.gov Identifier: NCT03685513
Recruitment Status : Unknown
Verified September 2018 by Abdelrahman Soliman Elsayed Badran, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Soliman Elsayed Badran, Cairo University

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
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 Other: BioHPP PEEK-based single posterior crowns Other: Metal ceramic single posterior crowns Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

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 Name: 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.




Primary Outcome Measures :
  1. Fracture [ Time Frame: 1 year ]
    Measured using modified USPHS criteria


Secondary Outcome Measures :
  1. Marginal adaptation [ Time Frame: 1 year ]
    Measured using modified USPHS criteria


Other Outcome Measures:
  1. Patient Satisfaction [ Time Frame: 1 year ]
    Measured using modified USPHS criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685513


Contacts
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Contact: Abdelrahman Badran, M.D.s 01007029340 asbadran77@gmail.com
Contact: Amina Zaki

Sponsors and Collaborators
Cairo University
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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: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Caries
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Tooth Demineralization