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Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01974362
First Posted: November 1, 2013
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andre Chen, Instituto de Implantologia
  Purpose
In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia, compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after 1-Year follow-up ?

Condition Intervention
Endosseous Dental Implant Failure Accident Caused by Broken Ceramic Device: Dental Implant Device: Monolithic Zirconia Device: Zirconia-Feldspathic

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Cad/Cam Monolithic Zirconia Behavior in Full-Mouth Implant Rehabilitation - Case-control Study

Resource links provided by NLM:


Further study details as provided by Andre Chen, Instituto de Implantologia:

Primary Outcome Measures:
  • Total Amount of Chipping [ Time Frame: at 1-Year post-insertion ]
    measure the total number of ceramic fractures (chipping) visible at naked eye in both groups (monolithic and feldspathic) that happen from insertion (baseline) to 1 year post-insertion.


Secondary Outcome Measures:
  • Number of Small Complications [ Time Frame: at 1-Year post Insertion ]

    Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to 1 year post-insertion.

    It is determined that if the complication was solved in the dental chair is considered a Small complication


  • Number of Big Complications [ Time Frame: at 1-Year post Insertion ]

    Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to 1 year post-insertion.

    It is determined that if the complication was solved in the dental laboratory is considered a Small complication



Estimated Enrollment: 20
Study Start Date: December 2016
Study Completion Date: March 1, 2017
Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cad/Cam Monolithic Zirconia
Patients that have a full-mouth (maxilla and mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial
Device: Dental Implant
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Other Name: Dental Fixtures
Device: Monolithic Zirconia
rehabilitation with monolithic zirconia implant-prosthesis
Other Name: Prettau®, Zirkonzhan®
Zirconia-Feldspathic
Patients that have a full-mouth (maxilla and mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
Device: Dental Implant
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Other Name: Dental Fixtures
Device: Zirconia-Feldspathic
restore dental implants with a zirconia suprastructure and feldspathic veneers
Other Name: Ice Ceramic ® Zirkonzhan®

Detailed Description:

Retrospectively study the behavior of implant supported rehabilitations made from full-zirconium dioxide (monolithic) and zirconia veneered with feldspathic in full-mouth type of rehabilitations (maxilla and mandible).

In a private clinic we will record the behavior, regarding chipping and complications in both groups (monolithic vs feldspathic ceramic) after 1 year in function.

We will make calibration of the investigators for chipping detection, characterization of big and small problem and accept an inter-observer agreement (Kappa) of 0.9 for each parameter.

Recording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from a dental office that did a full-mouth (bimaxillary - maxilla and mandible) implant-supported rehabilitation and made the final rehabilitation of both jaws in either monolithic zirconia or in feldspathic-zirconia
Criteria

Inclusion Criteria:

  • Maxilla and Mandible Implant full-mouth restoration
  • Both monolithic ceramic or both zirconia-feldspathic restoration
  • 1 Year Follow-up

Exclusion Criteria:

  • Less than 1 year follow-up
  • Not full mouth rehabilitation
  Contacts and Locations
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): NCT01974362


Locations
Portugal
Instituto de Implantologia
Lisbon, Portugal, 1600
Sponsors and Collaborators
Instituto de Implantologia
Investigators
Principal Investigator: Andre Chen, Msc Instituto de Implantologia
Principal Investigator: Pedro Crispim, Msc Instituto de Implantologia
Study Director: João Caramês, Phd Instituto de Implantologia
Study Chair: Helena Francisco, Msc Instituto de Implantologia
Study Chair: Andre Moreira, Msc Instituto de Implantologia
  More Information

Responsible Party: Andre Chen, Msc, Instituto de Implantologia
ClinicalTrials.gov Identifier: NCT01974362     History of Changes
Other Study ID Numbers: II-06
First Submitted: October 26, 2013
First Posted: November 1, 2013
Last Update Posted: November 7, 2017
Last Verified: December 2016

Keywords provided by Andre Chen, Instituto de Implantologia:
Monolithic Zirconia
Zirconia-Feldspathic zirconia
Dental Implants
Fracture
Chipping