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

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ClinicalTrials.gov Identifier: NCT04052789
Recruitment Status : Unknown
Verified August 2019 by Nahla Gamal Adly, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nahla Gamal Adly, Cairo University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth Other: BioHPP PEEK copings veneered with composite resin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Double(participant, outcome Assessor) Double blind
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Zirconia single posterior crowns veneered with ceramics
'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
 Other: BioHPP PEEK copings veneered with composite resin
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.
Experimental: BioHpp PEEK single posterior crowns veneered with compos
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
 Other: BioHPP PEEK copings veneered with composite resin
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.


Outcome Measures
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Primary Outcome Measures :
  1. Internal fit of the crown by measuring the thickness of the replica by steriomicroscope [ Time Frame: one year ]
    measured by replica technique and steriomicroscope


Secondary Outcome Measures :
  1. secondary caries if present at the margin of the crown by using probe [ Time Frame: one year ]

    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).



Other Outcome Measures:
  1. patient satisfaction [ Time Frame: one year ]
    Measured by VAS(questionnaire)Numerical (discrete) ("0" unsatisfied - "10" satisfied)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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
Contacts and Locations
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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): NCT04052789


Contacts
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Contact: Nahla Adly, M.D.S 01010604355 Dr.nahla.81@gmail.com
Contact: Amina Zaki, professor aazaki99@yahoo.co.uk

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Nahla Gamal Adly, Resident, Fixed Prosthodontices Department,Faculty of Dentistry, Cairo University
ClinicalTrials.gov Identifier: NCT04052789    
Other Study ID Numbers: CEBD-CU-2019-08-03
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
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