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

Study Overview
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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.

Official Title
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Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Randomized Controlled Clinical Trial

Conditions
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Implant-supported Single Crowns

Intervention / Treatment
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* Device: ZrO2 (Straumann CARES)
* Device: PFM crown (Straumann Gold)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZrO2<br>Straumann CARES Variobase Abutment RN Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1) | Device: ZrO2 (Straumann CARES)<br>* Straumann CARES Variobase Abutment RN Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)<br>|
| Active Comparator: PFM crown<br>Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic | Device: PFM crown (Straumann Gold)<br>* Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical complication rate | assessed by USPHS-criteria | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 6-month, 1, 3, 5, 7, 10 years | 
| Biological complication rate | assessed by bleeding on probing, pocket probing depth, marginal bone level | 6-month, 1, 3, 5, 7, 10 years | 
| Wear rate of the antagonist | assessed by a volumetric analysis software | 6-month, 1, 3, 5, 7, 10 years | 
| Technical complication rate | assessed by USPHS-criteria | 6-month, 1, 3 , 7, 10 years |