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Trial record 36 of 120 for:    ZIRCONIUM

Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering

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.
 
ClinicalTrials.gov Identifier: NCT02175329
Recruitment Status : Unknown
Verified March 2017 by Ivoclar Vivadent AG.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Ivoclar Vivadent AG

Tracking Information
First Submitted Date  ICMJE June 23, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
Number of participants with clinical success [ Time Frame: 2 years ]
Clinical success is defined as more than 95% survival of the restoration after 2 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02175329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
Restoration quality [ Time Frame: 1 week, 1 year, 2 years, 3 years, 4 years, 5 years ]
Characterisation of the restorations according to United States Public Health Services (USPHS) criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering
Official Title  ICMJE A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics
Brief Summary 60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.
Detailed Description Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Three-unit Posterior Bridges
Intervention  ICMJE
  • Device: CAD/CAM Veneering
    CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer
  • Device: Manually layered veneering
Study Arms  ICMJE
  • Experimental: CAD/CAM veneering
    CAD/CAM manufactured e.max CAD veneers on zirconia framework
    Intervention: Device: CAD/CAM Veneering
  • Active Comparator: manually layered
    Manually layered veneering on CAD/CAM fabricated zirconia bridge framework
    Intervention: Device: Manually layered veneering
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • single missing posterior tooth with two adjacent posterior teeth
  • no acute conservative or paradontal treatment need except for the teeth to be treated in the study
  • sufficient oral hygiene

Exclusion Criteria:

  • known allergies to components
  • bruxism
  • missing antagonist tooth
  • pregnancy or lactation
  • missing written consent
  • patients which are not expected to be compliant
  • severe systemic diseases
  • untreated carious lesions
  • untreated parodontitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02175329
Other Study ID Numbers  ICMJE CAD-On
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ivoclar Vivadent AG
Study Sponsor  ICMJE Ivoclar Vivadent AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Bindl, Dr.med.dent. Universität Zürich
PRS Account Ivoclar Vivadent AG
Verification Date March 2017

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