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| Name | Class |
|---|---|
| ITI Foundation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZR-TiB | Experimental | Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR) |
|
| PFM-GA | Active Comparator | Porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical complication rate | assessed by USPHS-criteria | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | 1, 3, 5 years | |
| Biological parameters | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| João Pitta, Dr | Contact | +41223794088 | joao.pitta@unige.ch |
| Name | Affiliation | Role |
|---|---|---|
| João Pitta, Dr | University of Geneva, Switzerland | Principal Investigator |
| Irena Sailer, Prof | University of Geneva, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva | Recruiting | Geneva | 1211 | Switzerland |
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| porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA) | Device | 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. |
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| 1, 3, 5 years |
| Wear rate of restoration and antagonist | assessed by a volumetric analysis software | 1, 3, 5 years |
| Patient Reported Outcomes Measures (PROMs) | 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] | 1, 3, 5 years |
| Cost-efficiency | assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue) | single-point measure at baseline |
| Accuracy of fabrication | measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow) | single-point measure at baseline |
| Operator Reported Outcomes Measures | 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] | single-point measure at baseline |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D003442 | Crowns |
| ID | Term |
|---|---|
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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