NCT04029025

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Partial-edentulism
• Implant-supported Fixed Dental Prostheses (iFDP)

Interventions

Type	Name	Description
PROCEDURE	Workflow A	Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)
PROCEDURE	Workflow B	3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)
PROCEDURE	Workflow C	Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)

Timeline

• Start date: 2019-06-26
• Primary completion: 2023-03-31
• Completion: 2023-06-30
• First posted: 2019-07-23
• Last updated: 2023-11-07

Locations

1 site across 1 country: Switzerland