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Zirconia Based Fixed Dental Prostheses

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ClinicalTrials.gov Identifier: NCT02220764
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
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Brief Summary:
The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.

Condition or disease Intervention/treatment Phase
Zirconia Based Fixed Dental Prostheses Device: Teeth abutment Device: Implant abutments Not Applicable

Detailed Description:
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses
Study Start Date : May 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs
Drug Information available for: Zirconium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tooth-supported
Long-span tooth-supported zirconia based fixed dental prostheses
 Device: Teeth abutment
Other Name: Zenotec system
Active Comparator: Implant-supported
Long-span implant-supported zirconia based fixed dental prostheses
 Device: Implant abutments
Other Names:
  • Zenotec system
  • Wital (Implant system)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Fixed Dental Prostheses (FDPs) With Failure [ Time Frame: 3 years ]
    "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.


Secondary Outcome Measures :
  1. Number of Fixed Dental Prostheses (FDPs) With Chip/s [ Time Frame: 3 years ]
    Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.


Other Outcome Measures:
  1. Number of of Fixed Dental Prostheses (FDPs) With Rough Surface [ Time Frame: 3 years ]
    Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Missing of at least two adjacent teeth in the maxilla or mandibular
  • Sufficient oral hygiene

Exclusion Criteria:

  • Addiction to alcohol or drugs
  • Severe craniomandibular disorders
  • Severe systematic diseases
  • Patients unable or unwilling to sign the informed consent form
  • Untreated periodontitis
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02220764    
Other Study ID Numbers: W-008
First Posted: August 20, 2014    Key Record Dates
Results First Posted: March 24, 2015
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Technische Universität Dresden:
prospective study
chipping
survival rate
fracture resistance
zirconia