Rotation of ToothNCT06418984
Clinical Trial to Compare Clear Aligners' Auxiliaries on Rotational Accuracy
A study testing auxiliary in people with Rotation of Tooth, run by University of Florida at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotation of Tooth
- What is being tested?
- auxiliary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Rotation of Tooth
- Being tested
- auxiliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auxiliaryDevice
the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No Interproximal reduction or attachments will be used to help correct the rotation |
| Inter proximal reduction | Experimental | Interproximal reduction will be performed in this arm Receives: Device: auxiliary |
| Optimized attachments | Experimental | optimized composite attachments will be added to this arm Receives: Device: auxiliary |
| IPR and optimized attachments | Experimental | Both Interproximal reduction will be implemented and optimized attachments will be added to this arm Receives: Device: auxiliary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Canine rotation
3D model superimposition will be used to assess the accuracy of tooth movement
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Oct 2024
- Primary completion15 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotation of ToothStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one control group and 3 experimental groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418984
- Sponsor's protocol ID
- IRB202400491
- Status last verified
- Mar 2025
- First submitted
- 8 May 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06418984
- Acronym / sponsor ID
- IRB202400491
- Conditions
- Rotation of Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- one control group and 3 experimental groups
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No Interproximal reduction or attachments will be used to help correct the rotation |
| Inter proximal reduction | Experimental | Device: auxiliaryInterproximal reduction will be performed in this arm |
| Optimized attachments | Experimental | Device: auxiliaryoptimized composite attachments will be added to this arm |
| IPR and optimized attachments | Experimental | Device: auxiliaryBoth Interproximal reduction will be implemented and optimized attachments will be added to this arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auxiliarythe interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement | Device | IPR and optimized attachments, Inter proximal reduction, Optimized attachments |
Primary outcome
Accuracy of Canine rotation
Time frame: 6-9 months
3D model superimposition will be used to assess the accuracy of tooth movement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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The Predictability of Directly Printed Versus Thermoformed Clear Aligners
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auxiliary in people with Rotation of Tooth, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Canine rotation (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.