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To Compare Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments

This study is currently recruiting participants.
Verified June 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01644630
First received: July 9, 2012
Last updated: July 16, 2012
Last verified: June 2012
History of Changes
  Purpose

The aim of this study is to test whether or not the use of screw-retained implant crowns on customized zirconia abutments results in biological, technical and esthetic outcomes similar to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both made with a computer-aided design and manufacturing procedure (CAD/CAM).

The null-hypotheses is that marginal bone level change is equal at screw-retained and cemented crowns


Condition Intervention
Implant-supported Single Crowns
 Procedure: Cemented crowns
Procedure: Screw-retained crowns

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Clinical Trial Comparing Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments

Resource links provided by NLM:

Drug Information available for: Zirconium
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Marginal bone level [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The bone level represents an indicator of the osseointegration and biological success of the implant.


Secondary Outcome Measures:
  • Biological, technical and esthetic outcome [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Radiographic bone level after 1 and 3 years

  • Biological, technical and esthetic outcome [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    implant survival after 1, 3 and 5 years

  • Biological, technical and esthetic outcome [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    rate of biological complications after 1, 3 and 5 years

  • Biological, technical and esthetic outcome [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    rate of technical complications after 1, 3 and 5 years


Estimated Enrollment: 34
Study Start Date: June 2012
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cemented single crowns
Cemented single crown: zirconia abutment (Straumann Cares abutment) with an all-ceramic lithium disilicate crown
 Procedure: Cemented crowns

The final lithium disilicate crowns will be cemented with an adhesive cement after tightening the abutments with the torque indicated by the manufacturer and closing the screw access hole with white guttapercha. The abutment will be cleaned with ethanol. A retraction cord will be placed for cementation if indicated. The crown will be etched with hydrofluoric acid and subsequently silanized. A sufficient amount of cement will be filled in the crown without creating major excesses. When the crown is seated correctly, the cement will be light-cured for a few seconds to facilitate the removal of the now hard excess cement.

- Excess cement will be meticulously removed with a carbon scaler. The removal of all excess cement will be checked with an X-ray and by visual and tactile inspection.
Active Comparator: Screw-retained single crown
Screw-retained single crown: zirconia abutment (Straumann Cares abutment), directly veneered with veneering ceramic
 Procedure: Screw-retained crowns
The screw-retained crowns will be inserted and tightened with the torque indicated by the manufacturer. The screw access hole will to be closed with white guttapercha and a composite filling (Filtek, 3M ESPE).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Single-tooth Straumann Bone Level in the anterior maxilla or mandible
  • At least one adjacent natural tooth present
  • Implant position enabling both screw-retained and cemented crown
  • Informed consent signed

Exclusion Criteria:

  • Smoking more than 15 cigarettes a day
  • Poor oral hygiene (Plaque index over 30%)
  • Pregnancy at the date of inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644630

Contacts
Contact: Karin Wolleb, Dr. +41 44 634 32 58 karin.wolleb@zzm.uzh.ch
Contact: Müller Gisela +41 44 634 33 84 gisela.mueller@zzm.uzh.ch

Locations
Switzerland
Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science Recruiting
Zurich, Switzerland, 8032
Contact: Karin Wolleb, Dr.     +41 44 634 32 58     karin.wolleb@zzm.uzh.ch    
Contact: Gisela Müller     +41 44 634 33 84     gisela.mueller@zzm.uzh.ch    
Principal Investigator: Karin Wolleb, Dr.            
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Karin Wolleb, Dr. Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01644630     History of Changes
Other Study ID Numbers: 2012-0147
Study First Received: July 9, 2012
Last Updated: July 16, 2012
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on May 16, 2013