Back to resultsBenefit of the Digital Workflow for Screw-retained Single Implant Restorations
Primary Purpose
Tooth Loss
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Impression procedure
Crown manufacturing procedures
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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:
- 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
- Immunocompromised patients
- Uncontrolled Diabetes
- Smokers
- Prisoners
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Optical impression
Conventional impression
Digital workflow
Conventional workflow
Arm Description
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).
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Time consumption in the lab
The time needed by the lab for manufacturing the crowns will be evaluated by timing all the different steps.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03234868
Brief Title
Benefit of the Digital Workflow for Screw-retained Single Implant Restorations
Official Title
Benefit of the Digital Workflow for Screw-retained Single Implant Restorations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 digital and conventional workflow. Additionally, patient centered outcomes will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optical impression
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional impression
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Digital workflow
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional workflow
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Impression procedure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Crown manufacturing procedures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fit of the crowns
Description
To measure this parameter we will focus on interproximal fit and occlusion. Interproximal contact points will be checked with dental floss.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time consumption at the dental chair
Description
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).
Time Frame
1 year
Title
Time consumption in the lab
Description
The time needed by the lab for manufacturing the crowns will be evaluated by timing all the different steps.
Time Frame
1 year
Title
Global cost
Description
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.
Time Frame
1 year
Title
Esthetical aspect
Description
A VAS evaluation of the esthetic properties (scoring from zero to ten each crown) will be achieved after the placement of each crown.
Time Frame
1 year
Title
Patient centered outcomes
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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:
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
Immunocompromised patients
Uncontrolled Diabetes
Smokers
Prisoners
12. IPD Sharing Statement
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Benefit of the Digital Workflow for Screw-retained Single Implant Restorations
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