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

NCT ID: NCT01644630

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-27

Study Completion Date

2019-11-11

Brief Summary

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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

Detailed Description

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Conditions

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Implant-supported Single Crowns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cemented single crowns

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

Group Type ACTIVE_COMPARATOR

Cemented crowns

Intervention Type 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.

Screw-retained single crown

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

Group Type ACTIVE_COMPARATOR

Screw-retained crowns

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Thoma, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Clinic of Reconstructive Dentistry

Locations

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Clinic of Reconstructive Dentistry

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2012-0147

Identifier Type: -

Identifier Source: org_study_id