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

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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

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.

Condition or disease Intervention/treatment Phase
Implant-supported Single Crowns Device: ZrO2 (Straumann CARES) Device: PFM crown (Straumann Gold) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Randomized Controlled Clinical Trial
Actual Study Start Date : October 2014
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
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)
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)

Active Comparator: PFM crown
Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
Device: PFM crown (Straumann Gold)
Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic




Primary Outcome Measures :
  1. Technical complication rate [ Time Frame: 5 years ]
    assessed by USPHS-criteria


Secondary Outcome Measures :
  1. Survival rate [ Time Frame: 6-month, 1, 3, 5 years ]
  2. Biological complication rate [ Time Frame: 6-month, 1, 3, 5 years ]
    assessed by bleeding on probing, pocket probing depth, marginal bone level

  3. Wear rate of the antagonist [ Time Frame: 6-month, 1, 3, 5 years ]
    assessed by a volumetric analysis software

  4. Technical complication rate [ Time Frame: 6-month, 1, 3 years ]
    assessed by USPHS-criteria



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02272491


Locations
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Switzerland
Clinic of Reconstructive Dentistry
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
ITI Foundation
Investigators
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Principal Investigator: Sven Mühlemann, Dr. Clinic of Reconstructive Dentistry

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02272491     History of Changes
Other Study ID Numbers: 2014-0191
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019