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One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).

Primary Purpose

Carious Tooth

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

About this trial

This is an interventional treatment trial for Carious Tooth

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • From 18-50 years old, be able to read and sign the informed consent document.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations
  • Psychologically and physically able to withstand conventional dental procedures
  • Patients with teeth problems indicated for single posterior crowns: (Badly decayed teeth / Teeth restored with large filling restorations / Endodontically treated teeth / Malformed teeth / Malposed teeth (Tilted, over-erupted, rotated, etc.) / Spacing between posterior teeth)
  • Able to return for follow-up examinations and evaluation.

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
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Lack of opposing dentition in the area of interest

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    zirconia veneered crowns

    milled BioHpp PEEK

    Arm Description

    we will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction

    we will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction

    Outcomes

    Primary Outcome Measures

    fracture
    number of fracture

    Secondary Outcome Measures

    marginal interity
    marginal gap at the finish line

    Full Information

    First Posted
    October 7, 2018
    Last Updated
    October 9, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03701178
    Brief Title
    One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).
    Official Title
    One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK) Versus Zirconia Veneered Single Crowns (Randomized Controlled Clinical Trial-one-year Evaluation).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2018 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    November 2019 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. Long term success of all ceramic crowns is affected by many factors. Fracture of the all ceramic crowns is the most repeated failure pattern and represents about 67% of total failures associated with this type of restoration through a period of 15 years of clinical performance. 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.
    Detailed Description
    Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years due to its lower Young's (elastic) modulus (3-4 GPa) being close to human bone. PEEK can be modified easily by incorporation of other materials. For example; incorporation of carbon fibers or glass fibers can increase the elastic modulus up to 18 GPa which becomes comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution . Moreover, tensile properties of PEEK are also analogous to those of bone, enamel and dentin making it a suitable restorative material as far as the mechanical properties are concerned. 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. BioHPP PEEK can be fabricated via CAD/CAM technology by milling PEEK blanks. It is also can be pressed by using granular or pellet-shaped PEEK. Three-unit PEEK fixed partial denture manufactured via CAD-CAM has been suggested to have a higher fracture resistance than pressed granular- or pellet-shaped PEEK dentures. The fracture resistance of the CAD/CAM milled PEEK fixed dentures is much higher than those of lithium disilicate glass-ceramic (950N), alumina (851N) , zirconia (981-1331N). The abrasive properties of PEEK are excellent. Despite of significantly low elastic moduli and hardness, abrasive resistance of PEEK is competitive with metallic alloys . BioHPP PEEK can be used under resin composite as a coping material. Because the mechanical properties of PEEK are similar to those of dentin and enamel, PEEK could have an advantage over alloy and ceramic restorations . A variety of procedures have been suggested to condition the surface of PEEK in order to facilitate its bonding with resin composite crowns. For example, air abrasion with and without silica coating creates a more wettable surface. Etching with sulphuric acid creates a rough and chemically altered surface which enables it to bond more effectively with hydrophobic resin composites . Due to these unique physical and mechanical properties, BioHPP PEEK is a promising material for dental application and it has been proposed for other prosthodontic applications such as fixed prostheses and removable prostheses .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carious Tooth

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    zirconia veneered crowns
    Arm Type
    Active Comparator
    Arm Description
    we will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction
    Arm Title
    milled BioHpp PEEK
    Arm Type
    Experimental
    Arm Description
    we will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction
    Intervention Type
    Other
    Intervention Name(s)
    BioHPP PEEK
    Intervention Description
    milled BioHPP PEEK in a new material can be used as a dental restoration
    Primary Outcome Measure Information:
    Title
    fracture
    Description
    number of fracture
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    marginal interity
    Description
    marginal gap at the finish line
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    patient satisfaction
    Description
    patient satisfy from the color and anatomy of the restoration
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: From 18-50 years old, be able to read and sign the informed consent document. Have no active periodontal or pulpal diseases, have teeth with good restorations Psychologically and physically able to withstand conventional dental procedures Patients with teeth problems indicated for single posterior crowns: (Badly decayed teeth / Teeth restored with large filling restorations / Endodontically treated teeth / Malformed teeth / Malposed teeth (Tilted, over-erupted, rotated, etc.) / Spacing between posterior teeth) Able to return for follow-up examinations and evaluation. 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 Pregnant women Patients in the growth stage with partially erupted teeth Psychiatric problems or unrealistic expectations Lack of opposing dentition in the area of interest
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    abdelrahman mustafa, M.D.s
    Phone
    01024884480
    Email
    dr_lamina_propria@windowslive.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lamia Sayed, Professor
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    abdelrahman M el sokkary, mastrer
    Organizational Affiliation
    researcher
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).

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