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

May 8, 2018 updated by: Lamiaa Said Zaki AbdelSalam Elfadaly, Cairo University

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esthetic outcome
Time Frame: 9 month
measured by pink and white esthetics score
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone resorption
Time Frame: 9 month
measured by CBCT and measuring unit Housfield Unit(HU)
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Lamiaa Abdelsalam, MSc, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2018

Primary Completion (Anticipated)

June 15, 2019

Study Completion (Anticipated)

September 15, 2019

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lamiaa Said Zaki Abd ElSalam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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