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Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics

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ClinicalTrials.gov Identifier: NCT03521024
Recruitment Status : Not yet recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Lamiaa Said Zaki AbdelSalam Elfadaly, Cairo University

Brief Summary:
aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments .

Condition or disease Intervention/treatment Phase
Tooth Loss Other: poly ether ketone ketone Other: lithium disilicate Not Applicable

Detailed Description:

High performance polymers may be a valid alternative to other conventional materials for abutments and crowns over zirconia implants because of their cushioning effect and elastic modulus (5.1GPa), which absorb occlusal forces and avoid overload of the underlying bone from the direct transmission of biting impacts ; which could optimize and preserve osseointegration with time. Zirconia implants with high performance polymers restorations can be considered a good alternative for replacing natural teeth.

For many years lithium disilicate has been the esthetics standard used in Veneers ,Inlays , onlays, occlusal veneers, partial crowns,minimally invasive crowns and Implant superstructures due to its natural-looking tooth colouring and excellent light-optical properties.

Due to the promising esthetics of high performance polymers as it can be veneered with different veneering materials it would successfully restore esthetics.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient will receive a restoration with superior function, esthetics, and quality.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Esthetic and Biomechanical Outcome of Maxillary Anterior Single-Tooth Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on PEKK Abutments: Randomized Controlled Trial
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: lithium disilicate crowns
lithium disilicate crowns are well documented in the literatures as successful restoration modality.
Other: poly ether ketone ketone
Polyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials

Other: lithium disilicate
well documented in the literatures as successful restoration modality.

Experimental: poly ether ketone ketone crowns
pekkton
Other: poly ether ketone ketone
Polyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials

Other: lithium disilicate
well documented in the literatures as successful restoration modality.




Primary Outcome Measures :
  1. Esthetic outcome [ Time Frame: 9 month ]
    measured by pink and white esthetics score


Secondary Outcome Measures :
  1. bone resorption [ Time Frame: 9 month ]
    measured by CBCT and measuring unit Housfield Unit(HU)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >18 years
  • No active intraoral or systemic disease
  • No pregnancy or lactation
  • controlled periodontal conditions
  • Adequate bone volume to place an implant
  • Occlusal function with a natural tooth

Exclusion Criteria:

  1. Current pregnancy.
  2. Psychiatric disorders.
  3. Smokers
  4. Poor motivation.
  5. Several occlusal parafunction.
  6. Persistent intraoral infections.
  7. Severe mucosal disease.
  8. Active periodontitis.
  9. Poor oral hygiene.
  10. Lack of occluding dentition at implant rehabilitation level

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): NCT03521024


Contacts
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Contact: lamiaa Abdelsalam, MSc 201015833015 dr.l.fadaly@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Lamiaa Abdelsalam, MSc Cairo University

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Responsible Party: Lamiaa Said Zaki AbdelSalam Elfadaly, Dr., Cairo University
ClinicalTrials.gov Identifier: NCT03521024     History of Changes
Other Study ID Numbers: Lamiaa Said Zaki Abd ElSalam
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 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

Keywords provided by Lamiaa Said Zaki AbdelSalam Elfadaly, Cairo University:
Zirconia implants
PEKK crowns
high performance polymer crowns

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Lithium Carbonate
Ether
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General
Anesthetics