Orthodontic Appliance ComplicationNCT06814262
Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors
A study testing Corresponding treatment order in the prescription with Align Technology, Superimposition of final and initial positions of lateral incisors: Predicted model and Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners in people with Orthodontic Appliance Complication, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Corresponding treatment order in the prescription with Align Technology, Superimposition of final and initial positions of lateral incisors: Predicted model and Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 1 Jun 2026
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
- The maxillary arch has less than 6 mm of crowding or spacing
- Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
- Maxillary lateral incisors within a normal range of bucco-lingual inclination
- Patients 12 years of age or older and either the patient or legal guardian are able to give consent
- Patients confirm good compliance throughout the study period
Who cannot join
- Patients do not complete all aligners in the first phase as prescribed
- Poor compliance recorded for aligner wear
- Restorations placed or oral surgery completed prior to final scan
- Midcourse intervention to improve tracking such as a bootstrap
- Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
- Treatment plans include surgery or extractions
Show all 9Show fewer
- Maxillary lateral incisors with pathology and restorations
- Missing teeth other than third molars
- Patients with anterior crossbite
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.
Read the detailed description
There are various expert theories regarding the most effective methods of extrusion and multiple studies performed in vitro to evaluate the efficacy of different attachment types on the extrusion of lateral incisors, however only one in vivo clinical trial exists. There is a need for more randomized clinical trials that evaluate the effectiveness of different attachment designs for achieving optimal extrusion of lateral incisors. By determining the most effective attachment size for maxillary lateral incisor extrusion, this study can help improve treatment outcomes for orthodontic treatment with clear aligners and serve as a guide to assist clinicians in selecting the most effective attachment design.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Corresponding treatment order in the prescription with Align Technology, Superimposition of final and initial positions of lateral incisors: Predicted model, Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners, Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners, Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners
- Keywords
- Extrusion of Maxillary Lateral Incisors, Clear Aligner Attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corresponding treatment order in the prescription with Align TechnologyDevice
Treating orthodontist placing the corresponding order in the prescription with Align Technology.
Superimposition of final and initial positions of lateral incisors: Predicted modelDevice
Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model will be superimposed with the predicted final model to establish the predicted movement of the maxillary lateral incisors
Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm alignersDevice
Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x3mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor.
Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm alignersDevice
Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x4mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor.
Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm alignersDevice
Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x5mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor.
| Study group | Role | What they receive |
|---|---|---|
| Control/optimized for extrusion.aligners | Placebo comparator | The control will be Invisalign's optimized attachment which will be specifically optimized for extrusion. Receives: Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Predicted model |
| Gingivally beveled 1x1x3mm aligners | Experimental | Each set of aligners would be worn for a week/gingivally beveled 1x1x3mm Receives: Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners |
| Gingivally beveled 1x1x4mm aligners | Experimental | Each set of aligners would be worn for a week/gingivally beveled 1x1x4mm Receives: Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners |
| Gingivally beveled 1x1x5mm aligners | Experimental | Each set of aligners would be worn for a week/gingivally beveled 1x1x5mm Receives: Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine which of three different attachment sizes offers more predictable extrusion of maxillary lateral incisors in subjects treated with clear aligners compared
The aim of this prospective, randomized controlled trial is to determine which of three different attachment sizes (gingivally beveled 1x1x3 mm, gingivally beveled 1x1x4 mm, or gingivally beveled 1x1x5 mm) offers more predictable extrusion of maxillary lateral incisors in patients treated with clear aligners compared to control.
Measured: baseline until the clear aligner treatment is completed at 20 to 25 weeks
Secondary outcomes (1)
Evaluate the accuracy of ClinCheck software
To evaluate the accuracy of ClinCheck software in predicting the three-dimensional final position of the lateral incisor following extrusion using the attachment designs tested.
Measured: baseline until the clear aligner treatment is completed at 20 to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start31 Mar 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Lindauer, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814262
- Sponsor's protocol ID
- HM20031880
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors
- ClinicalTrials.gov ID
- NCT06814262
- Acronym / sponsor ID
- HM20031880
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Extrusion of Maxillary Lateral Incisors, Clear Aligner Attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 7 Feb 2025 (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.
Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.
Detailed description
There are various expert theories regarding the most effective methods of extrusion and multiple studies performed in vitro to evaluate the efficacy of different attachment types on the extrusion of lateral incisors, however only one in vivo clinical trial exists. There is a need for more randomized clinical trials that evaluate the effectiveness of different attachment designs for achieving optimal extrusion of lateral incisors. By determining the most effective attachment size for maxillary lateral incisor extrusion, this study can help improve treatment outcomes for orthodontic treatment with clear aligners and serve as a guide to assist clinicians in selecting the most effective attachment design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control/optimized for extrusion.aligners | Placebo comparator | Device: Corresponding treatment order in the prescription with Align Technology, Device: Superimposition of final and initial positions of lateral incisors: Predicted modelThe control will be Invisalign's optimized attachment which will be specifically optimized for extrusion. |
| Gingivally beveled 1x1x3mm aligners | Experimental | Device: Corresponding treatment order in the prescription with Align Technology, Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm alignersEach set of aligners would be worn for a week/gingivally beveled 1x1x3mm |
| Gingivally beveled 1x1x4mm aligners | Experimental | Device: Corresponding treatment order in the prescription with Align Technology, Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm alignersEach set of aligners would be worn for a week/gingivally beveled 1x1x4mm |
| Gingivally beveled 1x1x5mm aligners | Experimental | Device: Corresponding treatment order in the prescription with Align Technology, Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm alignersEach set of aligners would be worn for a week/gingivally beveled 1x1x5mm |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
- The maxillary arch has less than 6 mm of crowding or spacing
- Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
- Maxillary lateral incisors within a normal range of bucco-lingual inclination
- Patients 12 years of age or older and either the patient or legal guardian are able to give consent
Key exclusion criteria (9 listed)
- Patients do not complete all aligners in the first phase as prescribed
- Poor compliance recorded for aligner wear
- Restorations placed or oral surgery completed prior to final scan
- Midcourse intervention to improve tracking such as a bootstrap
- Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
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 |
|---|---|---|
| Corresponding treatment order in the prescription with Align TechnologyTreating orthodontist placing the corresponding order in the prescription with Align Technology. | Device | Control/optimized for extrusion.aligners, Gingivally beveled 1x1x3mm aligners, Gingivally beveled 1x1x4mm aligners, Gingivally beveled 1x1x5mm aligners |
| Superimposition of final and initial positions of lateral incisors: Predicted modelSuperimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model will be superimposed with the predicted final model to establish the predicted movement of the maxillary lateral incisors | Device | Control/optimized for extrusion.aligners |
| Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm alignersSuperimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x3mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor. | Device | Gingivally beveled 1x1x3mm aligners |
| Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm alignersSuperimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x4mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor. | Device | Gingivally beveled 1x1x4mm aligners |
| Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm alignersSuperimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x5mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor. | Device | Gingivally beveled 1x1x5mm aligners |
Primary outcome
Determine which of three different attachment sizes offers more predictable extrusion of maxillary lateral incisors in subjects treated with clear aligners compared
Time frame: baseline until the clear aligner treatment is completed at 20 to 25 weeks
The aim of this prospective, randomized controlled trial is to determine which of three different attachment sizes (gingivally beveled 1x1x3 mm, gingivally beveled 1x1x4 mm, or gingivally beveled 1x1x5 mm) offers more predictable extrusion of maxillary lateral incisors in patients treated with clear aligners compared to control.
1 secondary outcome
Evaluate the accuracy of ClinCheck software
Time frame: baseline until the clear aligner treatment is completed at 20 to 25 weeks
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 8 Jun 2026.
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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.
Steven Lindauer principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corresponding treatment order in the prescription with Align Technology, Superimposition of final and initial positions of lateral incisors: Predicted model and Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners in people with Orthodontic Appliance Complication, run by Virginia Commonwealth University 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 6 inclusion and 9 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 8 Jun 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. Some participants in this study may receive a placebo. 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?
Determine which of three different attachment sizes offers more predictable extrusion of maxillary lateral incisors in subjects treated with clear aligners compared (time frame: baseline until the clear aligner treatment is completed at 20 to 25 weeks). 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 8 Jun 2026.