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

NCT01644630 | Completed

• 1 other identifier: 2012-0147
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Implant-supported Single Crowns

Outcome Measures

Primary Outcomes (1)

• Marginal bone level

  The bone level represents an indicator of the osseointegration and biological success of the implant.

  5 years

Secondary Outcomes (4)

• Biological, technical and esthetic outcome

  up to 5 years

• Biological, technical and esthetic outcome

  up to 5 years

• Biological, technical and esthetic outcome

  up to 5 years

• Biological, technical and esthetic outcome

  up to 5 years

Study Arms (2)

Cemented single crowns

ACTIVE COMPARATOR

Cemented single crown: zirconia abutment (Straumann Cares abutment) with an all-ceramic lithium disilicate crown

Procedure: Cemented crowns

Screw-retained single crown

ACTIVE COMPARATOR

Screw-retained single crown: zirconia abutment (Straumann Cares abutment), directly veneered with veneering ceramic

Procedure: Screw-retained crowns

Interventions

Cemented crowns PROCEDURE

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.

Cemented single crowns

Screw-retained crowns PROCEDURE

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).

Screw-retained single crown

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smoking more than 15 cigarettes a day
• Poor oral hygiene (Plaque index over 30%)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Clinic of Reconstructive Dentistry

Zurich, 8032, Switzerland

Location

Study Officials

• Daniel Thoma, Prof. Dr.

  Clinic of Reconstructive Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 19, 2012
• Study Start: July 27, 2012
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

CH (1)