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

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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

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.

Condition or disease Intervention/treatment Phase
Three-unit Posterior Bridges Device: CAD/CAM Veneering Device: Manually layered veneering Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics
Study Start Date : January 2010
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: CAD/CAM veneering
CAD/CAM manufactured e.max CAD veneers on zirconia framework
Device: CAD/CAM Veneering
CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer

Active Comparator: manually layered
Manually layered veneering on CAD/CAM fabricated zirconia bridge framework
Device: Manually layered veneering



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175329


Locations
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Switzerland
Universität Zürich, Zentrum für Zahn-, Mund- und Kieferheilkunde
Zürich, Switzerland, 8032
Sponsors and Collaborators
Ivoclar Vivadent AG
Investigators
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Principal Investigator: Andreas Bindl, Dr.med.dent. Universität Zürich

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Responsible Party: Ivoclar Vivadent AG
ClinicalTrials.gov Identifier: NCT02175329     History of Changes
Other Study ID Numbers: CAD-On
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Ivoclar Vivadent AG:
CAD/CAM, three-unit posterior bridges, zirconia framework