Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM
Study Details
Study Description
Brief Summary
The aim of is to compare the survival rate and technical outcomes of cantilever implant-supported fixed denture prosthetics (cFDPs) made either out of monolithic zirconia bonded to a titanium base in a digital workflow, or porcelain fused-to metal using a gold abutment in a conventional workflow. In addition, biological outcomes, wear patterns, PROMs and time efficiency will be recorded. The null hypothesis is: the reconstruction type does not influence the survival rate and technical outcomes of 2-unit implant-supported cFDP.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ZR-TiB Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR) |
Device: Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)
In group ZR-TiB the implant impressions will be taken using an intra-oral scanner and the respective scanbody. The restorations will be manufactured by means of CAD/CAM procedures using monolithic zirconia. For sufficient aesthetics, the zirconia restorations can be manually veneered with veneering ceramic only at the buccal surface, while the occlusal surface will remain monolithic and will be high-gloss polished. The zirconia restorations will be extra-orally cemented onto titanium base abutments (Straumann® Variobase® for crown, Straumann AG), correctly polished and delivered to the patient, by screw-retention onto the implant.
Other Names:
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| Active Comparator: PFM-GA Porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM) |
Device: porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)
In group PFM-GA implant impression will be taken using a polyvinyl siloxane or polyether impression material in a conventional manner with the use of stock trays and corresponding impression copings. The framework will be manufactured by the lost wax-technique using a gold-abutment (Straumann® Gold abutment for crown, Straumann AG) and a gold-alloy. All metal frameworks will be manually veneered with veneering ceramic, polished and glazed, and delivered to the patient, by screw-retention onto the implant.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Technical complication rate [5 years]
assessed by USPHS-criteria
Secondary Outcome Measures
- Survival rate [1, 3, 5 years]
- Biological parameters [1, 3, 5 years]
assessed by clinical examination by measuring with a periodontal probe: bleeding on probing (yes/no per site), pocket probing depth (mm), width of keratinized mucosa (mm), assessed by evaluation of standardized x-rays: marginal bone level changes (mm)
- Wear rate of restoration and antagonist [1, 3, 5 years]
assessed by a volumetric analysis software
- Patient Reported Outcomes Measures (PROMs) [1, 3, 5 years]
assessed through questionnaires: Oral Health Impact Profile (OHIP-14) to evaluate oral health-related quality of life [0-4 for each of the 14 questions, where 4 represents the worst outcome]; Visual Analogue Scales (VAS) to evaluate patient experience with the impression procedure [0-10, where 10 represents the best outcome]
- Cost-efficiency [single-point measure at baseline]
assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue)
- Accuracy of fabrication [single-point measure at baseline]
measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow)
- Operator Reported Outcomes Measures [single-point measure at baseline]
assessed through Visual Analogue Scales (VAS) to evaluate operator experience with the impression procedure and with the adjustment of the restoration [0-10, where 10 represents the best outcome]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Minimal age of 22 years old.
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No general medical condition which represents a contraindication to implant treatment
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Good oral hygiene (PII ≤ 20%), and healthy periodontal tissues (BOP≤ 20%)
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Two adjacent-teeth gap in posterior maxilla or mandible arch (first premolar, second premolar, first molar, second molar) with an osseointegrated regular or wide-diameter bone-level implant in a prosthetically correct position to allow occlusal screw-retention. Free-end edentulous gaps can also be included
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Presence of antagonist occlusal units
Exclusion Criteria:
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Severe bruxism or clenching habits
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Patients with inadequate oral hygiene or persistent intraoral infection
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Women who are pregnant or breast feeding at the day of inclusion
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Smokers exceeding 15 cigarettes / day, or equivalent; patients chewing tobacco
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Unable or unwilling to cooperate for the trial period
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Estimated cantilever crown mesial-distal length > 10 mm
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Estimated implant crown height (from implant platform to occlusal contact points) > 15 mm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Geneva | Geneva | Switzerland | 1211 |
Sponsors and Collaborators
- University of Geneva, Switzerland
- ITI Foundation
Investigators
- Principal Investigator: João Pitta, Dr, University of Geneva
- Study Chair: Irena Sailer, Prof, University of Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Cantilver study