Benefit of the Digital Workflow for Screw-retained Single Implant Restorations
NCT ID: NCT03234868
Last Updated: 2017-07-31
Study Results
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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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2016-01-01
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optical impression
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).
Impression procedure
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.
Conventional impression
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.
Impression procedure
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.
Digital workflow
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.
Crown manufacturing procedures
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.
Conventional workflow
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.
Crown manufacturing procedures
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.
Interventions
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Impression procedure
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 procedures
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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%
Exclusion Criteria
* 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
* Immunocompromised patients
* Uncontrolled Diabetes
* Smokers
* Prisoners
ALL
Yes
Sponsors
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University of Liege
OTHER
Responsible Party
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Dr. France LAMBERT
Prof.
Other Identifiers
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H2015-4
Identifier Type: -
Identifier Source: org_study_id