Clinical Trial to Compare Clear Aligners' Auxiliaries on Rotational Accuracy
NCT ID: NCT06418984
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-01
2025-12-28
Brief Summary
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Detailed Description
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To assess the accuracy of the achieved outcomes and compare the outcomes of the four treatment groups, the collected digital models (predicted simulated models and achieved final scanned models) will be superimposed and compared to assess the accuracy and predictability of rotational tooth movement in the included subjects, and treatment outcomes will be evaluated. The differences between the positions of each tooth in the two digital models (predicted from Clincheck and achieved from the final scan) will quantified for rotation: differences of 2° or more rotation will be considered clinically relevant. These values were chosen from the American Board of Orthodontics (ABO) model grading system for case evaluation and other clinical studies.5 Additionally, data related to treatment duration, number of aligners, and number of visits needed to complete the treatment will be gathered and analyzed in a de-identified form.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
No Interproximal reduction or attachments will be used to help correct the rotation
No interventions assigned to this group
Inter proximal reduction
Interproximal reduction will be performed in this arm
auxiliary
the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
Optimized attachments
optimized composite attachments will be added to this arm
auxiliary
the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
IPR and optimized attachments
Both Interproximal reduction will be implemented and optimized attachments will be added to this arm
auxiliary
the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
Interventions
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auxiliary
the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
Eligibility Criteria
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Inclusion Criteria
* Male or female above 18 years old
* Full permanent dentition except for the third molars
* Any type of malocclusion with rotated canines that require derotation
* Good oral hygiene and absence of periodontal disease
* Malocclusion to be treated with Invisalign aligners (SmartTrack)
* Any ethnic group
Exclusion Criteria
* An extraction treatment plan
* Poor oral hygiene
* Patients with syndromes or craniofacial anomalies.
* The use of any other orthodontic appliance than clear aligners' (Invisalign)
* Malocclusion that requires auxiliaries in the simulated plan ( buttons and elastics on the canines)
18 Years
45 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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IRB202400491
Identifier Type: -
Identifier Source: org_study_id
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