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Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.

Primary Purpose

Endodontically Treated Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEK
Emax
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects are required to be:

  • From 18-60 years old, and able to read and sign the informed consent document.
  • Physically and psychologically able to tolerate conventional restorative procedures
  • Have no active periodontal or pulpal diseases.
  • Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

  • Patients in the growth stage with partially erupted teeth
  • Patient with fractured teeth of more than 50% enamel loss
  • Patients with poor oral hygiene and motivation
  • Pregnant women
  • Psychiatric problems or unrealistic expectations
  • Lack of opposite occluding dentition in the area intended for restoration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PEEK

    Emax

    Arm Description

    PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics,1 Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel. Yet clinical studies are needed to evaluate their clinical performance.

    lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns

    Outcomes

    Primary Outcome Measures

    evaluation of marginal gap
    Marginal gap of the restorations assessed by Silicon replica technique using digital microscope

    Secondary Outcome Measures

    Clinical evaluation of marginal adaptation
    Marginal adaptation of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
    Clinical evaluation of fracture resistance
    Fracture resistance of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)

    Full Information

    First Posted
    July 15, 2019
    Last Updated
    August 6, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04023357
    Brief Title
    Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
    Official Title
    Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 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
    Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal adaptation.so a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel. .but the investigators have to know clinically it is performance , so the investigators are going to have Parallel groups in a randomized clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endodontically Treated Teeth

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PEEK
    Arm Type
    Experimental
    Arm Description
    PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics,1 Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel. Yet clinical studies are needed to evaluate their clinical performance.
    Arm Title
    Emax
    Arm Type
    Active Comparator
    Arm Description
    lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns
    Intervention Type
    Other
    Intervention Name(s)
    PEEK
    Other Intervention Name(s)
    BioHPP polyetheretherketones
    Intervention Description
    New polyetheretherketones material
    Intervention Type
    Other
    Intervention Name(s)
    Emax
    Other Intervention Name(s)
    lithium disilicate glass ceramic
    Intervention Description
    standard etchable glass ceramic used for Endocrowns
    Primary Outcome Measure Information:
    Title
    evaluation of marginal gap
    Description
    Marginal gap of the restorations assessed by Silicon replica technique using digital microscope
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Clinical evaluation of marginal adaptation
    Description
    Marginal adaptation of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
    Time Frame
    1 Year
    Title
    Clinical evaluation of fracture resistance
    Description
    Fracture resistance of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
    Time Frame
    1 Year
    Other Pre-specified Outcome Measures:
    Title
    Clinical evaluation of Retention
    Description
    Retention of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)
    Time Frame
    1 Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All subjects are required to be: From 18-60 years old, and able to read and sign the informed consent document. Physically and psychologically able to tolerate conventional restorative procedures Have no active periodontal or pulpal diseases. Willing to return for follow-up examinations and evaluation Exclusion Criteria: Patients in the growth stage with partially erupted teeth Patient with fractured teeth of more than 50% enamel loss Patients with poor oral hygiene and motivation Pregnant women Psychiatric problems or unrealistic expectations Lack of opposite occluding dentition in the area intended for restoration
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Youssef, M.D.S
    Phone
    01064019439
    Email
    Ahmedmohamedosman90@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omaima Elmahlawy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26110927
    Citation
    Otto T, Mormann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German.
    Results Reference
    background
    PubMed Identifier
    27692583
    Citation
    Zoidis P, Bakiri E, Polyzois G. Using modified polyetheretherketone (PEEK) as an alternative material for endocrown restorations: A short-term clinical report. J Prosthet Dent. 2017 Mar;117(3):335-339. doi: 10.1016/j.prosdent.2016.08.009. Epub 2016 Sep 28.
    Results Reference
    background
    PubMed Identifier
    28955538
    Citation
    Sevimli G, Cengiz S, Oruc MS. Endocrowns: review. J Istanb Univ Fac Dent. 2015 Apr 29;49(2):57-63. doi: 10.17096/jiufd.71363. eCollection 2015.
    Results Reference
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    Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.

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