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Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Instituto de Implantologia
Sponsor:
Information provided by (Responsible Party):
Andre Chen, Instituto de Implantologia
ClinicalTrials.gov Identifier:
NCT01974362
First received: October 26, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted

October 26, 2013
October 26, 2013
January 2014
August 2014   (final data collection date for primary outcome measure)
Total Amount of Chipping [ Time Frame: at 1-Year post-insertion ] [ Designated as safety issue: Yes ]
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.
Same as current
No Changes Posted
  • Number of Small Complications [ Time Frame: at 1-Year post Insertion ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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

Same as current
Not Provided
Not Provided
 
Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
Cad/Cam Monolithic Zirconia Behavior in Full-Mouth Implant Rehabilitation - Case-control Study

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 ?

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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

  • Endosseous Dental Implant Failure
  • Accident Caused by Broken Ceramic
  • 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®
  • Device: Zirconia-Feldspathic
    restore dental implants with a zirconia suprastructure and feldspathic veneers
    Other Name: Ice Ceramic ® Zirkonzhan®
  • Cad/Cam Monolithic Zirconia
    Patients that have a full-mouth (maxilla and mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial
    Interventions:
    • Device: Dental Implant
    • Device: Monolithic Zirconia
  • Zirconia-Feldspathic
    Patients that have a full-mouth (maxilla and mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
    Interventions:
    • Device: Dental Implant
    • Device: Zirconia-Feldspathic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
January 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Portugal
 
NCT01974362
II-06
No
Andre Chen, Instituto de Implantologia
Instituto de Implantologia
Not Provided
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
Instituto de Implantologia
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP