An observational study in Malocclusion, sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by IRCCS Ospedale San Raffaele · Observational
The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. The study will include patients who are candidates for aligner orthodontics treatment. After having acquired the standard initial diagnostic data (clinical examination, intra- and extra-oral photographs, intra- and extra-oral scans, orthopantomography and lateral-lateral teleradiography of the skull), the digital impressions of the arches will be used to plan the dental movements necessary for correction of malocclusion.
The aligners will then be designed using orthodontic CAD software and realized using a thermoformed and direct 3D printing process.
All patients will be treated following current recommendations relating to the orthodontic treatments in question. After delivery of the aligners, during each check-up, intra-oral and extra-oral scans will be acquired to evaluate the actual position of the teeth and, using special software will be compare the virtually designed position with tooth with the clinical outcomes. Any discrepancies will be recorded and statistically analyzed.There are no additional invasive procedures. Intra- and extra-oral scans will be acquired regularly to monitor the extent of tooth movement over time.
469 studies on the registry are indexed under Malocclusion; 91 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 79 observational studies indexed under Malocclusion.
Browse Malocclusion studies →IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will be selected from patients aged 18 years and older who require orthodontic treatment with clear aligners. One hundred patients will be enrolled, without distinction based on gender.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who need orthodontic treatment.
Evaluate accuracy aligners of on transversal dental linear movements
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the transversal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Time frame: 18 months
Evaluate accuracy aligners of on vertical dental linear movements
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the vertical plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Time frame: 18 months
Evaluate accuracy aligners of on sagittal dental linear movements
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the sagittal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Time frame: 18 months
Evaluate accuracy of 3d printed aligners on transversal dental angular movements
Correspondence between virtual planned angular movements (in degrees) and clinical outcomes achieved using aligners evaluated on the transversal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Time frame: 18 months
Evaluate accuracy of 3d printed aligners on sagittal dental angular movements
Correspondence between virtual planned angular movements (in degrees) and clinical outcomes achieved using aligners evaluated on the sagittal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Time frame: 18 months
Evaluate accuracy of 3d printed aligners on vertical dental angular movements
Correspondence between virtual planned angular movements (in degrees) and clinical outcomes achieved using aligners evaluated on the vertical plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Time frame: 18 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Nov 2024; primary completion for Sep 2027, 34 months later.
Of 33 observational studies under Malocclusion, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's planned 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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IRCCS Ospedale San Raffaele