Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study

Not yet recruiting

• Conditions: Malocclusion

• Registration Number: NCT06561945
• Lead Sponsor: IRCCS Ospedale San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Study Start: 2024-11-01
• Primary Completion: 2027-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age between 18 and 65 years
2. Good general health
3. Presence of a dental/skeletal malocclusion
4. Permanent dentition with second molars completely erupted in the arch
5. Correct tooth shape, with sufficient height of the clinical crowns
6. Good compliance during treatment

Exclusion Criteria

1. Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
2. Orofacial malformations or syndromes
3. Periodontal disease
4. Smoke
5. Pregnancy
6. Signs and/or symptoms of temporomandibular disorders
7. Absence of teeth (except for third molars)
8. Dental Implants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate accuracy aligners of on transversal dental linear movements	18 months	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	18 months	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	18 months	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 Outcome Measures

Name	Time	Method
Evaluate accuracy of 3d printed aligners on sagittal dental angular movements	18 months	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	18 months	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
Evaluate accuracy of 3d printed aligners on transversal dental angular movements	18 months	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