Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering

Study Overview
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Brief Summary
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60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.

Detailed Description
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Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.

Official Title
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A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics

Conditions
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Three-unit Posterior Bridges

Intervention / Treatment
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* Device: CAD/CAM Veneering
* Device: Manually layered veneering


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single missing posterior tooth with two adjacent posterior teeth no acute conservative or paradontal treatment need except for the teeth to be treated in the study sufficient oral hygiene Exclusion Criteria: known allergies to components bruxism missing antagonist tooth pregnancy or lactation missing written consent patients which are not expected to be compliant severe systemic diseases untreated carious lesions untreated parodontitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: CAD/CAM veneering<br>CAD/CAM manufactured e.max CAD veneers on zirconia framework | Device: CAD/CAM Veneering<br>* CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer<br>|
| Active Comparator: manually layered<br>Manually layered veneering on CAD/CAM fabricated zirconia bridge framework | Device: Manually layered veneering<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinical success | Clinical success is defined as more than 95% survival of the restoration after 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration quality | Characterisation of the restorations according to United States Public Health Services (USPHS) criteria | 1 week, 1 year, 2 years, 3 years, 4 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD/CAM, three-unit posterior bridges, zirconia framework