Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial

NCT ID: NCT02272491

Last Updated: 2023-05-15

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2027-11-01

Brief Summary

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The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region.

Detailed Description

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In the majority of studies on implant-supported restorations, a considerable rate of fractures of the veneering ceramic was reported. The clinical data is restricted to full-ceramic implant-supported reconstructions in the anterior region. No clinical data is available on the performance of full-ceramic restorations in the molar region.

The use of translucent monolithic zirconia for implant-supported crowns (without veneering ceramic) may reduce the technical complication rate and allow for sufficient aesthetic results in the molar region. To date, no clinical trial investigating monolithic zirconia crowns for single molar implants is available.

The primary outcome of the study is the technical complication rate. This outcome represents an indicator for the prosthetic success of the implant-supported crown. The main biological secondary outcomes are marginal bone level, histological signs of inflammation, and presence of pathogenic bacteria. Further outcomes are crown survival, wear of the crown and of the antagonist.

Conditions

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Implant-supported Single Crowns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZrO2

1. Straumann CARES Variobase Abutment RN
2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)

Group Type EXPERIMENTAL

ZrO2 (Straumann CARES)

Intervention Type DEVICE

1. Straumann CARES Variobase Abutment RN
2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)

PFM crown

Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic

Group Type ACTIVE_COMPARATOR

PFM crown (Straumann Gold)

Intervention Type DEVICE

Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic

Interventions

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ZrO2 (Straumann CARES)

1. Straumann CARES Variobase Abutment RN
2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)

Intervention Type DEVICE

PFM crown (Straumann Gold)

Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed Consent as documented by signature
* Male and female patients from 18-80 years of age
* Presence of a Straumann Tissue Level implant with a regular platform (4.8 mm diameter platform) in the maxillary or mandibular molar region
* Need for a single implant-supported crown
* Implant position enabling screw-retained crown
* Presence of antagonist

Exclusion Criteria

* Women who are pregnant at the date of inclusion
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Smoking more than 15 cigarettes a day
* Poor oral hygiene (Plaque Index over 30%)
* Bruxism
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ITI Foundation

INDUSTRY

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Ioannidis, 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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2014-0191

Identifier Type: -

Identifier Source: org_study_id

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