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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-26

Study Completion Date

2023-06-30

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blinded double-randomized controlled trial (RCT) with crossover design

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Workflow A

Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)

Group Type ACTIVE_COMPARATOR

Workflow A

Intervention Type PROCEDURE

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)

Group Type ACTIVE_COMPARATOR

Workflow B

Intervention Type PROCEDURE

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).

Group Type ACTIVE_COMPARATOR

Workflow C

Intervention Type PROCEDURE

Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)

Interventions

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Workflow A

Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)

Intervention Type PROCEDURE

Workflow B

3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)

Intervention Type PROCEDURE

Workflow C

Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No