About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 65 years
Good general health
Presence of a dental/skeletal malocclusion
Permanent dentition with second molars completely erupted in the arch
Disqualifiers
Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
Orofacial malformations or syndromes
Periodontal disease
Smoke
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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
Secondary outcomes
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
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
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
Locations
Sponsors and contacts
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