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

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University Hospital Basel

Status

Completed

Conditions

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

Treatments

Procedure: Workflow A
Procedure: Workflow C
Procedure: Workflow B

Study type

Interventional

Funder types

Other

Identifiers

NCT04029025
2019-00706 ex19Joda;

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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