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

November 6, 2023 updated by: University Hospital, Basel, Switzerland

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
work time (days)
Time Frame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of clinical appointments
Time Frame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
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)
chair-time in units per minutes
Time Frame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
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)
volumetric difference
Time Frame: at Visit 3 (an average of 30 days)
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)
Change in Functional Implant Prosthodontic Score (FIPS)
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Tim Joda, Prof. Dr., Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2019

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-00706; ex19Joda

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Partial-edentulism

Clinical Trials on Workflow A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe