Complete Digital Workflows for the Treatment With Multiple-unit Implant-supported Fixed Dental Prostheses (iFDP)

Study Overview
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Brief Summary
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This study is to assess socio-economic factors, clinical and virtual precision, patient-centered outcomes, and esthetics during the treatment with monolithic multi-unit iFDPs in a complete digital workflow

Detailed Description
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Fixed Dental Prosthesis (FDPs) are the treatment of choice for the rehabilitation of partial-edentulism, especially in posterior (free-end) sites. Compared to classical tooth-bourne removable prostheses, the implant-based treatment approach is a more biological approach protecting the neighboring teeth including surrounding tissues. In addition, it is a more comfortable solution for the patient but often represents a time- and cost-intensive treatment modality. Therefore, it is of great interest to offer the advantages of Implant-supported Fixed Dental Prosthesis (iFDP) to a broader patient population. Thus, this is only possible if new technologies are affordable, which can shorten the overall clinical treatment time and the technical production process to achieve a reasonable cost-benefit ratio in combination with a high quality outcome of the final prosthodontic reconstruction. At this time, the classical impression technique with implant transfer posts and elastomeric materials for the manufacturing of master casts out of gypsum still represents the gold standard for implant prosthodontic reconstructions. The conventional approach involves biological, technical, patient-related and economic compromises such as complex and costly technical manufacturing steps. An alternative to this established method is the digital implant workflow. In contrast to the conventional approach, the digital process can virtually detect the 3D implant position in a contact-free way with an Intraoral Scanner (IOS) device including further technical processing with Computer-Aided-Design (CAD)/ Computer-Aided-Manufacturing (CAM) technology. Recently, the entire production process of monolithic iFDPs is introduced starting with IOS and following a virtual construction without any physical model situations. In addition, the production of the iFDP itself is simplified by the option to connect a full-contour monolithic Zirconium dioxide (ZrO2) reconstruction to pre-fabricated bonding base abutments in a complete digital workflow without any physical master casts. This study is to assess socio-economic factors, clinical and virtual precision, patient-centered outcomes, and esthetics during the treatment with monolithic multi-unit iFDPs in a complete digital workflow without any physical model situation.

Official Title
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Complete Digital Workflows for the Treatment With Multiple-unit Implant-supported Fixed Dental Prostheses (iFDP): A Double-blinded Double-randomized Controlled Trial (RCT)

Conditions
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Partial-edentulism, Implant-supported Fixed Dental Prostheses (iFDP)

Intervention / Treatment
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* Procedure: Workflow A
* Procedure: Workflow B
* Procedure: Workflow C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-unit implant-supported Fixed Dental Prostheses (iFDP) in maxillary and mandibular sites for the replacement of premolars or molars at least one interproximal contact and occlusal contacts to the antagonists Exclusion Criteria: uncontrolled systemic disease that would interfere with dental implant therapy patients who smoke > 10 cigarettes per day or tobacco equivalents alcohol and/or drug abuse patients with chronic pain patients with untreated periodontitis and / or inadequate oral hygiene medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blinded double-randomized controlled trial (RCT) with crossover design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Workflow A<br>Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A) | Procedure: Workflow A<br>* Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)<br>|
| Active Comparator: Workflow B<br>3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B) | Procedure: Workflow B<br>* 3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)<br>|
| Active Comparator: Workflow C<br>Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C). | Procedure: Workflow C<br>* Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| work time (days) | work time for preparation, each production step such as computer-based design, waiting times between the various process steps, e.g. postal delivery from the external milling center, bonding of the full-contoured iFDPs to the prefabricated titanium abutments | from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of clinical appointments | number of clinical appointments needed for the clinical treatment steps will be recorded | from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days) | 
| chair-time in units per minutes | chair-time in units per minutes for the clinical treatment steps will be recorded | from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days) | 
| volumetric difference | calculation of volumetric differences for the iFDPs using the software geomagic (virtual accuracy measured and compared for the different workflows by means of superimposition of the gathered Standard Tessellation Language (STL)-files of each originally designed CAD-reconstruction and the secondary digitization with a laboratory scanner of all iFDPs after clinical try-in) | at Visit 3 (an average of 30 days) | 
| Change in Functional Implant Prosthodontic Score (FIPS) | FIPS defined by 5 variables: (1) interproximal, (2) occlusion, (3) design, (4) mucosa (5) bone. Scoring scheme of 0-1-2 is assigned for each variable, resulting in a maximum score of ten (5 × 2). The variable Interproximal is assessed for mesial-distal contact areas and the papillary presence of the adjacent dentition. Occlusion is evaluated for static and dynamic patterns and Design for contour, shape, color and finish. The 3 variables related to restoration are scored as major discrepancy (0), minor discrepancy (1), or no discrepancy (2). Quality and quantity of peri-implant soft tissue conditions is categorized under Mucosa as non-keratinized/non-attached (0), non-keratinized/attached (1), or keratinized + attached (2). Marginal bone levels are analyzed under Bone assessing the radiographic level of the alveolar crest mesially and distally: loss > 1.5 mm (0), loss < 1.5 mm (1), and no loss (2). Higher score represents better outcome. | at Visit 3 (an average of 30 days), Visit 4 (an average of 35 days), Visit 5 (6 months Follow-up), Visit 6 (12 months Follow-up), Visit 7 (24 months Follow-up), Visit 8 (36 months Follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conventional porcelain-fused-to metal iFDP, Dentalwings DWOS Intraoral Scan, 3Shape TRIOS Pod Intraoral Scan, Dentalwings DWOS Implant Prosthetics Lab-Software, Straumann CARES Lab-Software, digital implant workflow, CAD/CAM-technology