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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01644630
First received: July 9, 2012
Last updated: February 18, 2014
Last verified: February 2014

July 9, 2012
February 18, 2014
June 2012
December 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01644630 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
To Compare Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
A Randomized Controlled Clinical Trial Comparing Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Implant-supported Single Crowns
  • 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.

  • 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).
  • Active Comparator: Cemented single crowns
    Cemented single crown: zirconia abutment (Straumann Cares abutment) with an all-ceramic lithium disilicate crown
    Intervention: Procedure: Cemented crowns
  • Active Comparator: Screw-retained single crown
    Screw-retained single crown: zirconia abutment (Straumann Cares abutment), directly veneered with veneering ceramic
    Intervention: Procedure: Screw-retained crowns
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
34
Not Provided
December 2018   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01644630
2012-0147
No
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Karin Wolleb, Dr. Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich
University of Zurich
February 2014

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