RCT: Titanium vs FCZ vs Zirconia Framework

Study Overview
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Brief Summary
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In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short follow up duration. The aim being to evaluate the clinical outcome of implant-anchored posterior bridges, made from high-translucent monolithic zirconia, zirconia ceramic with porcelain and metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required. A total of 60 research subjects will be included in the study. Patients in need of a permanent implant-supported bridge, located posterior of the canine in the upper or lower jaw will be asked for participation. Each subject will be treated according to standard treatment protocols with implants from Nobel Biocare, the Branemark implant system and then be randomly assigned to obtain one of the following three type of bridges. 20 research subjects will be included in each of the three study arms. The prosthetic treatment will be carried out according to standard clinic protocol. All research subjects will be evaluated after 1, 3, 5 years. X-rays and photos will be taken at the installation of the bridges and after 1 and 5 years of follow-up or more frequent, depending on individual indication of the patient and the associated standard clinical care protocol. Personal data, implant survival, marginal bone loss and biological and technical complications related to the implants will be recorded. Survival of the bridge, technical and biological complication related to the bridge will also be recorded

Official Title
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RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials

Conditions
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Dental Prosthesis Failure

Intervention / Treatment
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* Device: High-translucent monolithic zirconia Bridge
* Device: Zirconium oxide ceramics Framework
* Device: Metal-ceramic Framework


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: edentulous behind the canine in the maxilla or mandible older than 18 years Exclusion Criteria: younger than 18 years active periodontitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Active Comparator: High-translucent monolithic zirconia,<br> | Device: High-translucent monolithic zirconia Bridge<br>* Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).<br>|
| Active Comparator: Zirconia ceramic with porcelain<br> | Device: Zirconium oxide ceramics Framework<br>* Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).<br>|
| Active Comparator: Metal ceramics.<br> | Device: Metal-ceramic Framework<br>* Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | From placement of prosthetic Bridge until last follow-up of the study after 5 years |