Clinical trial NCT06418984: Clinical Trial to Compare Clear Aligners' Auxiliaries on Rotational Accuracy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotation of Tooth
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one control group and 3 experimental groups
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria

* Physically healthy with no relevant allergies or medical problems
* 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

* Orthognathic surgical cases
* 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)

Primary outcomes:
measure: Accuracy of Canine rotation
timeFrame: 6-9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: