Partial-edentulismNCT04029025
Complete Digital Workflows for the Treatment With Multiple-unit Implant-supported Fixed Dental Prostheses (iFDP)
A study testing Workflow A, Workflow B and Workflow C in people with Partial-edentulism and Implant-supported Fixed Dental Prostheses (iFDP), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial-edentulism, Implant-supported Fixed Dental Prostheses (iFDP)
- What is being tested?
- Workflow A, Workflow B and Workflow C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jun 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel
Basel, 4056
About this study
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)
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
Read the 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.
- Being tested
- Workflow A, Workflow B, Workflow C
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workflow AProcedure or surgery
Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)
Workflow BProcedure or surgery
3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)
Workflow CProcedure or surgery
Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)
| Study group | Role | What they receive |
|---|---|---|
| Workflow A | Active comparator | Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A) Receives: Procedure: Workflow A |
| Workflow B | Active comparator | 3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B) Receives: Procedure: Workflow B |
| Workflow C | Active comparator | Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C). Receives: Procedure: Workflow C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
Secondary outcomes (4)
number of clinical appointments
number of clinical appointments needed for the clinical treatment steps will be recorded
Measured: 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
chair-time in units per minutes for the clinical treatment steps will be recorded
Measured: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)
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)
Measured: at Visit 3 (an average of 30 days)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start26 Jun 2019
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Partial-edentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded double-randomized controlled trial (RCT) with crossover design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Joda, Prof. Dr., Principal investigator, Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029025
- Sponsor's protocol ID
- 2019-00706; ex19Joda
- Other IDs
- 2019
- Status last verified
- Nov 2023
- First submitted
- 17 Jul 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34208773Joda 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.
PubMed 34391875
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04029025
- Acronym / sponsor ID
- 2019-00706; ex19Joda
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blinded double-randomized controlled trial (RCT) with crossover design
| Arm | Type | Receives |
|---|---|---|
| Workflow A | Active comparator | Procedure: Workflow ADentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A) |
| Workflow B | Active comparator | Procedure: Workflow B3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B) |
| Workflow C | Active comparator | Procedure: Workflow CConventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workflow ADentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A) | Procedure or surgery | Workflow A |
| Workflow B3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B) | Procedure or surgery | Workflow B |
| Workflow CConventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C) | Procedure or surgery | Workflow C |
Primary outcome
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
4 secondary outcomes
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)
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)
volumetric difference
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Results publication: PubMed 34208773Gintaute 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.
- Results publication: PubMed 34391875Joda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Joda, Prof. Dr. principal investigator
Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workflow A, Workflow B and Workflow C in people with Partial-edentulism and Implant-supported Fixed Dental Prostheses (iFDP), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
work time (days) (time frame: from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.