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

Partial-edentulism Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029025
• Other study ID #: 2019-00706; ex19Joda
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Switzerland	Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)