Tooth LossPhase 4NCT03234868
Benefit of the Digital Workflow for Screw-retained Single Implant Restorations
A Phase 4 study testing Impression procedure and Crown manufacturing procedures in people with Tooth Loss, run by University of Liege.
Trial summary
The aim of this research project is emphasize the benefit of the digital workflow compared to conventional impressions and crown processing with standard la procedures. The objectives of the present study are to measure and compare the global cost, the time spent in the dental chair and in the lab and the fit of both… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Impression procedure and Crown manufacturing procedures
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to Jun 2017
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject must have voluntarily signed the informed consent form before any study related action
- Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
- Men/Women
- In good systemic health (ASA I/ II)
- Present with no contra indication against oral surgical interventions
- Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
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- At least 10 mm of bone in the vertical dimension
- At least 6 mm of bone in the bucco-lingual dimension.
- No need for bone augmentation procedure in any of the dimensions
- Full mouth plaque score (FMPI) lower or equal than 25%
Who cannot join
- Autoimmune disease require medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously or more then
- Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
- Alcoholism or chronically drug abuse
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- Immunocompromised patients
- Uncontrolled Diabetes
- Smokers
- Prisoners
About this study
The aim of this research project is emphasize the benefit of the digital workflow compared to conventional impressions and crown processing with standard la procedures. The objectives of the present study are to measure and compare the global cost, the time spent in the dental chair and in the lab and the fit of both digital and conventional workflow. Additionally, patient centered outcomes will be recorded.
- Conditions
- Tooth Loss
- Being tested
- Impression procedure, Crown manufacturing procedures
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impression procedureDevice
Each patient will go through both type of impression during single appointment: first the digital impression and then the conventional one (to avoid residual impression materials for the optical impressions). The time necessary for each procedure will be recorded.
Crown manufacturing proceduresDevice
Test and control implant crowns will be screw-retained on a multi-unit abutment. The conventional crown will be made of a Zirconia framework veneered with cosmetic ceramics directly screwed on the multi-unit platform (no titanium base). The experimental crown will be made in full zirconia and designed in the TRIOS software.
| Study group | Role | What they receive |
|---|---|---|
| Optical impression | Experimental | The optical impression system used for the study is TRIOS (3 shape). First of all, the operators in charge of taking the digital impressions are going to get trained prior the study and will calibrate (learning curve). MIS Scan bodies will be placed on the multi-unit plaforms, an x-ray will be taken in order to check the fit) and the impression will be realised following the instruction given by the system (first the maxillary and mandibular impressions followed by the bite registration). Shade will be chosen using VITA toothguide 3D master (to pick the right zirconia shade). Receives: Device: Impression procedure |
| Conventional impression | Active comparator | Once the impression coping is placed on the multi-unit plaform, the fit will be checked with an intra-oral X-ray. The impressions will be made with medium viscosity silicon. As a second step, alginate antagonist impression will be done. Bite will not be recorded (single tooth missing). The two impressions will be placed in a hermetic plastic bag and send to lab. Shade will be chosen using VITA toothguide 3D master. Receives: Device: Impression procedure |
| Digital workflow | Experimental | The implant crowns issued from digital impressions will be done according a cast less / full digital workflow. The STL files collected from the TRIOS will be sent directly to the lab. The designing of the full zirconia crowns will be performed in the TRIOS 3SHAPE program. The resulting files will be sent to the CAM unit production (Amman Girrbach milling machine \& MAZAK CNC machine: Mcenter to be specify (Berlin or Israel) to be milled (milled \& sintered only) considering the direct adaption for a Multi-Unit connection. A superficial make-up will be done on the monolithic crown in the lab. And finally, the products will be delivered to the dentist. Receives: Device: Crown manufacturing procedures |
| Conventional workflow | Active comparator | The implant crowns issued from conventional impressions will be realised by sending the impressions to the lab (Mirko Picone). The lab will pour the impressions in dental stone (class 4 scannable without powdering: extra hard and scanning powder included). Then, the technician will realize a mock-up of the crown's framework on a temporary abutment in DuraLay Resin.
The mock up will be scanned with ZIRKONZAHN scanner (or equivalent) and send this information to a central fabrication facility for milling (Amman Girrbach milling machine \& MAZAK CNC machine:
Mcenter: to be specify (Berlin or Israel). The lab technician will get the Zi framework back and will apply veneer ceramic. Receives: Device: Crown manufacturing procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit of the crowns
To measure this parameter we will focus on interproximal fit and occlusion. Interproximal contact points will be checked with dental floss.
Measured: 1 year
Secondary outcomes (5)
Time consumption at the dental chair
Numbers of appointment needed for each procedure will be counted and each one of them will be timed (from the unscrewing of the healing abutment until its replacement).
Measured: 1 year
Time consumption in the lab
The time needed by the lab for manufacturing the crowns will be evaluated by timing all the different steps.
Measured: 1 year
Global cost
Considering the time spent by the dentist and the lab technician, the cost of the optical impression system, of impression materials, of impression trays, of scan bodies and of impression copings, the final cost of each crown will be compared.
Measured: 1 year
Esthetical aspect
A VAS evaluation of the esthetic properties (scoring from zero to ten each crown) will be achieved after the placement of each crown.
Measured: 1 year
Patient centered outcomes
A questionnaire based on VAS scales will be given out and filled by the patients. Thus it will be possible to estimate which of both impressions is less unpleasant for them (questionnaire are in developement).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Jan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234868
- Sponsor's protocol ID
- H2015-4
- Status last verified
- Jul 2017
- First submitted
- 13 Apr 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of the Digital Workflow for Screw-retained Single Implant Restorations
- ClinicalTrials.gov ID
- NCT03234868
- Acronym / sponsor ID
- H2015-4
- Conditions
- Tooth Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 Jul 2017 (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.
The aim of this research project is emphasize the benefit of the digital workflow compared to conventional impressions and crown processing with standard la procedures. The objectives of the present study are to measure and compare the global cost, the time spent in the dental chair and in the lab and the fit of both digital and conventional workflow. Additionally, patient centered outcomes will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Optical impression | Experimental | Device: Impression procedureThe optical impression system used for the study is TRIOS (3 shape). First of all, the operators in charge of taking the digital impressions are going to get trained prior the study and will calibrate (learning curve). MIS Scan bodies will be placed on the multi-unit plaforms, an x-ray will be taken in order to check the fit) and the impression will be realised following the instruction given by the system (first the maxillary and mandibular impressions followed by the bite registration). Shade will be chosen using VITA toothguide 3D master (to pick the right zirconia shade). |
| Conventional impression | Active comparator | Device: Impression procedureOnce the impression coping is placed on the multi-unit plaform, the fit will be checked with an intra-oral X-ray. The impressions will be made with medium viscosity silicon. As a second step, alginate antagonist impression will be done. Bite will not be recorded (single tooth missing). The two impressions will be placed in a hermetic plastic bag and send to lab. Shade will be chosen using VITA toothguide 3D master. |
| Digital workflow | Experimental | Device: Crown manufacturing proceduresThe implant crowns issued from digital impressions will be done according a cast less / full digital workflow. The STL files collected from the TRIOS will be sent directly to the lab. The designing of the full zirconia crowns will be performed in the TRIOS 3SHAPE program. The resulting files will be sent to the CAM unit production (Amman Girrbach milling machine \& MAZAK CNC machine: Mcenter to be specify (Berlin or Israel) to be milled (milled \& sintered only) considering the direct adaption for a Multi-Unit connection. A superficial make-up will be done on the monolithic crown in the lab. And finally, the products will be delivered to the dentist. |
| Conventional workflow | Active comparator | Device: Crown manufacturing proceduresThe implant crowns issued from conventional impressions will be realised by sending the impressions to the lab (Mirko Picone). The lab will pour the impressions in dental stone (class 4 scannable without powdering: extra hard and scanning powder included). Then, the technician will realize a mock-up of the crown's framework on a temporary abutment in DuraLay Resin. The mock up will be scanned with ZIRKONZAHN scanner (or equivalent) and send this information to a central fabrication facility for milling (Amman Girrbach milling machine \& MAZAK CNC machine: Mcenter: to be specify (Berlin or Israel). The lab technician will get the Zi framework back and will apply veneer ceramic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must have voluntarily signed the informed consent form before any study related action
- Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
- Men/Women
- In good systemic health (ASA I/ II)
- Present with no contra indication against oral surgical interventions
Key exclusion criteria (10 listed)
- Autoimmune disease require medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously or more then
- Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
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 |
|---|---|---|
| Impression procedureEach patient will go through both type of impression during single appointment: first the digital impression and then the conventional one (to avoid residual impression materials for the optical impressions). The time necessary for each procedure will be recorded. | Device | Conventional impression, Optical impression |
| Crown manufacturing proceduresTest and control implant crowns will be screw-retained on a multi-unit abutment. The conventional crown will be made of a Zirconia framework veneered with cosmetic ceramics directly screwed on the multi-unit platform (no titanium base). The experimental crown will be made in full zirconia and designed in the TRIOS software. | Device | Conventional workflow, Digital workflow |
Primary outcome
Fit of the crowns
Time frame: 1 year
To measure this parameter we will focus on interproximal fit and occlusion. Interproximal contact points will be checked with dental floss.
5 secondary outcomes
Time consumption at the dental chair
Time frame: 1 year
Time consumption in the lab
Time frame: 1 year
Global cost
Time frame: 1 year
Esthetical aspect
Time frame: 1 year
Patient centered outcomes
Time frame: 1 year
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 31 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Impression procedure and Crown manufacturing procedures in people with Tooth Loss, run by University of Liege.
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 10 inclusion and 10 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fit of the crowns (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2017.