Clinical Trial to Compare Clear Aligners' Auxiliaries on Rotational Accuracy

NCT ID: NCT06418984

Last Updated: 2025-03-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-28

Brief Summary

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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

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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.

Conditions

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Rotation of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one control group and 3 experimental groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

No Interproximal reduction or attachments will be used to help correct the rotation

Group Type NO_INTERVENTION

No interventions assigned to this group

Inter proximal reduction

Interproximal reduction will be performed in this arm

Group Type EXPERIMENTAL

auxiliary

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

auxiliary

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

auxiliary

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah H Abu Arqub, BDS MSc

Role: CONTACT

352-273-5700

Other Identifiers

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IRB202400491

Identifier Type: -

Identifier Source: org_study_id

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