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

Implant-supported Single Crowns Clinical Trial

Official title:

A Randomized Controlled Clinical Trial Comparing Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644630
• Other study ID #: 2012-0147
• Status: Completed
• Phase: N/A
• Start date: July 27, 2012
• Est. completion date: November 11, 2019

Study information

• Verified date: November 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Implant-supported Single Crowns

Intervention

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.
• 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).

Locations

Country	Name	City	State
Switzerland	Clinic of Reconstructive Dentistry	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone level	The bone level represents an indicator of the osseointegration and biological success of the implant.	5 years
Secondary	Biological, technical and esthetic outcome	Radiographic bone level after 1 and 3 years	up to 5 years
Secondary	Biological, technical and esthetic outcome	implant survival after 1, 3 and 5 years	up to 5 years
Secondary	Biological, technical and esthetic outcome	rate of biological complications after 1, 3 and 5 years	up to 5 years
Secondary	Biological, technical and esthetic outcome	rate of technical complications after 1, 3 and 5 years	up to 5 years