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Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial (MonoZrO2crown)

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: NCT02272491
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
ITI Foundation
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 23, 2014
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Technical complication rate [ Time Frame: 5 years ]
assessed by USPHS-criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
  • Survival rate [ Time Frame: 6-month, 1, 3, 5 years ]
  • Biological complication rate [ Time Frame: 6-month, 1, 3, 5 years ]
    assessed by bleeding on probing, pocket probing depth, marginal bone level
  • Wear rate of the antagonist [ Time Frame: 6-month, 1, 3, 5 years ]
    assessed by a volumetric analysis software
  • Technical complication rate [ Time Frame: 6-month, 1, 3 years ]
    assessed by 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 Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial
Official Title  ICMJE Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Randomized Controlled Clinical Trial
Brief Summary The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region.
Detailed Description

In the majority of studies on implant-supported restorations, a considerable rate of fractures of the veneering ceramic was reported. The clinical data is restricted to full-ceramic implant-supported reconstructions in the anterior region. No clinical data is available on the performance of full-ceramic restorations in the molar region.

The use of translucent monolithic zirconia for implant-supported crowns (without veneering ceramic) may reduce the technical complication rate and allow for sufficient aesthetic results in the molar region. To date, no clinical trial investigating monolithic zirconia crowns for single molar implants is available.

The primary outcome of the study is the technical complication rate. This outcome represents an indicator for the prosthetic success of the implant-supported crown. The main biological secondary outcomes are marginal bone level, histological signs of inflammation, and presence of pathogenic bacteria. Further outcomes are crown survival, wear of the crown and of the antagonist.

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 Implant-supported Single Crowns
Intervention  ICMJE
  • Device: ZrO2 (Straumann CARES)
    1. Straumann CARES Variobase Abutment RN
    2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)
  • Device: PFM crown (Straumann Gold)
    Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
Study Arms  ICMJE
  • Experimental: ZrO2
    1. Straumann CARES Variobase Abutment RN
    2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)
    Intervention: Device: ZrO2 (Straumann CARES)
  • Active Comparator: PFM crown
    Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
    Intervention: Device: PFM crown (Straumann Gold)
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 13, 2018)
83
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2014)
80
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent as documented by signature
  • Male and female patients from 18-80 years of age
  • Presence of a Straumann Tissue Level implant with a regular platform (4.8 mm diameter platform) in the maxillary or mandibular molar region
  • Need for a single implant-supported crown
  • Implant position enabling screw-retained crown
  • Presence of antagonist

Exclusion Criteria:

  • Women who are pregnant at the date of inclusion
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Smoking more than 15 cigarettes a day
  • Poor oral hygiene (Plaque Index over 30%)
  • Bruxism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 NCT02272491
Other Study ID Numbers  ICMJE 2014-0191
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE ITI Foundation
Investigators  ICMJE
Principal Investigator: Sven Mühlemann, Dr. Clinic of Reconstructive Dentistry
PRS Account University of Zurich
Verification Date July 2019

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