Clinical trial NCT04029025: Complete Digital Workflows for the Treatment With Multiple-unit Implant-supported Fixed Dental Prostheses (iFDP)
Official title: Complete Digital Workflows for the Treatment With Multiple-unit Implant-supported Fixed Dental Prostheses (iFDP): A Double-blinded Double-randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial-edentulism
Implant-supported Fixed Dental Prostheses (iFDP)
Keywords: 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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded double-randomized controlled trial (RCT) with crossover design
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: work time (days)
timeFrame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
Secondary outcomes:
measure: number of clinical appointments
timeFrame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
measure: chair-time in units per minutes
timeFrame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
measure: volumetric difference
timeFrame: at Visit 3 (an average of 30 days)
measure: Change in Functional Implant Prosthodontic Score (FIPS)
timeFrame: 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)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel
Study officials:
affiliation: Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel
name: Tim Joda, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gintaute A, Weber K, Zitzmann NU, Bragger U, Ferrari M, Joda T. A Double-Blind Crossover RCT Analyzing Technical and Clinical Performance of Monolithic ZrO2 Implant Fixed Dental Prostheses (iFDP) in Three Different Digital Workflows. J Clin Med. 2021 Jun 16;10(12):2661. doi: 10.3390/jcm10122661.
citation: Joda T, Gintaute A, Bragger U, Ferrari M, Weber K, Zitzmann NU. Time-efficiency and cost-analysis comparing three digital workflows for treatment with monolithic zirconia implant fixed dental prostheses: A double-blinded RCT. J Dent. 2021 Oct;113:103779. doi: 10.1016/j.jdent.2021.103779. Epub 2021 Aug 13.