Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570499
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Comparison of Conventional Impressions Intraoral Scanners and Digital Photogrammetry for Full-arch Implant Prosthesis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision Patient Satisfaction and Timing of Complete-arch Digital Implant Impression With a Conventional Impression an Intraoral Scanner and a Photogrammetry Technique A Prospective Clinical Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to compare implant-supported definitive impressions in edentulous patients mandible or maxilla with 4 to 8 osseointegrated implants The main questions it aims to answer are
The primary outcome of this prospective clinical comparative study is to analyse the precision of a complete-arch impression
The secondary aim is to obtain patient satisfaction with these new types of impression
The different impressions conventional intraoral scanner and photogrammetry will be taken twice on the same patient
The primary outcome of this prospective clinical comparative study is to analyse the precision of a complete-arch impression
The secondary aim is to obtain patient satisfaction with these new types of impression
The different impressions conventional intraoral scanner and photogrammetry will be taken twice on the same patient
Detailed Description:
For each patient 6 impressions were taken in the same order 2 IOS 2 photogrammetry 2 conventional impressions A satisfaction questionnaire in the form of a Visual Analogue Scale VAS was given after each group of impressions The time required for each impression was also measured
Clinical and laboratory Protocol The conventional impression will taken in plaster using an open tray technique Dr Balzer Special plaster Siladent The impression copings Impression Coping Open Tray Multi-unit NobelBiocare will be screwed onto the transgingival abutments The plaster wil then prepared with the 50100 waterpowder ratio recommended by the manufacturer The resulting impression will then cast with low-extension plaster and digitized using a high-precision laboratory scanner The entire procedure wil be conducted twice
The IOS impression will obtained using an intraoral scanner TRIOS4 3Shape AS with implant scan bodies screwed at the multiunit abutment level Elos Accurate Multi-Unit Elos Medtech The IOS device will be a wireless powder-free scanner with a pen grip based on confocal microscopy laser technology and operated with software version 1475 calibrated immediately before the impression The scanning strategy will be consistent for all procedures consisting of a first scan of the gingiva and implants in accordance with the manufacturers recommendations The scanbodies will be then hand screwed and a second scan will be performed using the following scan path from the last distal implant in a zigzag pattern26 The entire procedure will be conducted twice
Photogrammetry will be carried out using an Imetric camera ICam4D Imetric4D Imaging Sàrl The first step will be to use an intraoral scanner to scan the gingiva and optical markers screwed onto the transgingival abutments In a second step the scan bodies with superficial target points and titanium interfaces ICamBody Imetric4D Imaging Sàrl will be hand screwed to the transgingival components The ICamBodies will be placed with a visible edge in accordance with the manufacturers recommendations The operator will set up the photogrammetric camera ICam4D Imetric4D Imaging Sàrl and directly capture the scan bodies from right to left at 10 cm to 15 cm from the lips At least 2 sides of the scan body with 3 target points on each side will be captured according to the manufacturers instructions The scanbodies will be unscrewed and screwed back in random order and a second recording will be made after recalibrating the photogrammetry The coordinates from the photogrammetry will be exported the to dedicated software to be merged with the STL file form the intraoral scanner The entire procedure will be conducted twice
Patient-reported outcome measures PROMs PROMs will be obtained using a Visual Analog Scale VAS 27 immediately after the impression For each impression technique six domains will be used to evaluate which of the two was less unpleasant a opinion on treatment length 1 unsatisfactory to 10 excellent b comfort level during impression procedures 1 unsatisfactory to 10 excellent c anxiety level before impression procedures 1 high to 10 low d unpleasant taste duringafter impression procedures 1 bad taste to 10 none e nausea during the impression procedure 1 severe to 10 none and f pain during impression procedures 1 painful to 10 none For all Visual Analog Scales VAS higher scores indicated greater satisfaction with the procedure
Clinical and laboratory Protocol The conventional impression will taken in plaster using an open tray technique Dr Balzer Special plaster Siladent The impression copings Impression Coping Open Tray Multi-unit NobelBiocare will be screwed onto the transgingival abutments The plaster wil then prepared with the 50100 waterpowder ratio recommended by the manufacturer The resulting impression will then cast with low-extension plaster and digitized using a high-precision laboratory scanner The entire procedure wil be conducted twice
The IOS impression will obtained using an intraoral scanner TRIOS4 3Shape AS with implant scan bodies screwed at the multiunit abutment level Elos Accurate Multi-Unit Elos Medtech The IOS device will be a wireless powder-free scanner with a pen grip based on confocal microscopy laser technology and operated with software version 1475 calibrated immediately before the impression The scanning strategy will be consistent for all procedures consisting of a first scan of the gingiva and implants in accordance with the manufacturers recommendations The scanbodies will be then hand screwed and a second scan will be performed using the following scan path from the last distal implant in a zigzag pattern26 The entire procedure will be conducted twice
Photogrammetry will be carried out using an Imetric camera ICam4D Imetric4D Imaging Sàrl The first step will be to use an intraoral scanner to scan the gingiva and optical markers screwed onto the transgingival abutments In a second step the scan bodies with superficial target points and titanium interfaces ICamBody Imetric4D Imaging Sàrl will be hand screwed to the transgingival components The ICamBodies will be placed with a visible edge in accordance with the manufacturers recommendations The operator will set up the photogrammetric camera ICam4D Imetric4D Imaging Sàrl and directly capture the scan bodies from right to left at 10 cm to 15 cm from the lips At least 2 sides of the scan body with 3 target points on each side will be captured according to the manufacturers instructions The scanbodies will be unscrewed and screwed back in random order and a second recording will be made after recalibrating the photogrammetry The coordinates from the photogrammetry will be exported the to dedicated software to be merged with the STL file form the intraoral scanner The entire procedure will be conducted twice
Patient-reported outcome measures PROMs PROMs will be obtained using a Visual Analog Scale VAS 27 immediately after the impression For each impression technique six domains will be used to evaluate which of the two was less unpleasant a opinion on treatment length 1 unsatisfactory to 10 excellent b comfort level during impression procedures 1 unsatisfactory to 10 excellent c anxiety level before impression procedures 1 high to 10 low d unpleasant taste duringafter impression procedures 1 bad taste to 10 none e nausea during the impression procedure 1 severe to 10 none and f pain during impression procedures 1 painful to 10 none For all Visual Analog Scales VAS higher scores indicated greater satisfaction with the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None