Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

This study is not yet open for participant recruitment.
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
  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 Instituto de Implantologia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01974362

Locations
Portugal
Instituto de Implantologia Not yet recruiting
Lisbon, Portugal, 1600
Contact: joana velez    (+351) 217 210 980    joana.velez@institutodeimplantologia.com   
Principal Investigator: Andre Chen, Msc         
Principal Investigator: João Caramês, Msc         
Principal Investigator: Pedro Crispim, Msc         
Principal Investigator: Helena Francisco, Msc         
Sub-Investigator: Andre Moreira, Msc         
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

No publications provided

Responsible Party: Andre Chen, Msc, Instituto de Implantologia
ClinicalTrials.gov Identifier: NCT01974362     History of Changes
Other Study ID Numbers: II-06
Study First Received: October 26, 2013
Last Updated: October 26, 2013
Health Authority: Portugal: Health Ethic Committee

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

ClinicalTrials.gov processed this record on April 17, 2014