Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.

Study Overview
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Brief Summary
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This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.

Detailed Description
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90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein). Patients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure. The study has been approved by the Regional Ethical Board in Lund, Sweden

Official Title
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Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical Trial Comparing Glass-ceramic Crowns to Monolithic Translucent Zirconia Crowns With and Without a Semi-veneer

Conditions
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Dental Prosthesis Failure

Intervention / Treatment
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* Combination Product: IPS e.max CAD, Ivoclar Vivadent
* Combination Product: BruxZir, Glidewell
* Combination Product: BruxZir*, Glidewell


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: need of one or more dental crowns in the posterior dentition, premolars and molars Exclusion criteria: high caries activity/risk for caries and/or advanced periodontal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glass-ceramic<br>30 dental crowns of lithium-disilicate glass-ceramic | Combination Product: BruxZir, Glidewell<br>* Type: high translucent zirconia<br>Combination Product: BruxZir*, Glidewell<br>* Type: high translucent zirconia with a mini-veneer of porcelain<br>|
| Active Comparator: Zirconia<br>30 dental crowns of high translucent zirconia | Combination Product: IPS e.max CAD, Ivoclar Vivadent<br>* Type: monolithic lithium-disilicate glass ceramic<br>Combination Product: BruxZir*, Glidewell<br>* Type: high translucent zirconia with a mini-veneer of porcelain<br>|
| Active Comparator: Zirconia with mini-veneer<br>30 dental crowns of high translucent zirconia with a mini-veneer of porcelain | Combination Product: IPS e.max CAD, Ivoclar Vivadent<br>* Type: monolithic lithium-disilicate glass ceramic<br>Combination Product: BruxZir, Glidewell<br>* Type: high translucent zirconia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical perfomance | To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system. | 12 month | 
| Clinical perfomance | To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system. | 24 month | 
| Clinical perfomance | To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system. | 36 month | 
| Clinical perfomance | To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system. | 60 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaire | Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied'). | 12 month | 
| Patient questionnaire | Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied'). | 24 month | 
| Patient questionnaire | Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied'). | 36 month | 
| Patient questionnaire | Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied'). | 60 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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all ceramic, zirconia, crown, clinal trial