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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014