Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418984
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-08
Brief Title:
Clinical Trial to Compare Clear Aligners Auxiliaries on Rotational Accuracy
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Randomized Clinical Trial to Compare the Influence of Optimized Attachments IPR and a Combination of Both Techniques on the Rotational Accuracy of Canines With Clear Aligners
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized clinical trial aims to assess the effectiveness of optimized attachments IPR and a combination of the two techniques on the rotational accuracy of canines with clear aligners
Detailed Description:
Study Visit 1 V1 Upon fitting the inclusion criteria the patient will be randomized to one of the four interventional groups A member of the study team will collect the initial orthodontics records These records include two radiographs a panoramic radiograph and a lateral cephalogram intraoral and extraoral photographs and an iTero intraoral digital scan The scan will be sent directly to the Align Technology Invisalign doctor platform to begin the process of fabricating the desired aligners according to the clinical instructions for the simulated treatment plan by the study team and the randomly assigned group for the patient Study Visit 2 V2 5 weeks following visit 1 Invisalign aligners will be delivered to the included and randomized subjects and associated treatment rendered Subjects will be instructed to wear their aligners full-time except while eating drinking and brushing and change their aligners as recommended by Invisalign every week Study Visit 3 V3 The trial will end after the patient has completed wearing the first stage of aligners Final records will be collected these include iTero intraoral digital scans to construct the 3D digital models intraoral and extraoral photographs and radiographs
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 studies5 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
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 studies5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None