Clear Aligners' Auxiliaries for Malocclusion

Overseen By Sarah H Abu Arqub, BDS MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Orthognathic surgery, Extraction plan, Poor hygiene, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6-9 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well different techniques work with clear aligners to straighten crooked teeth, focusing on the canines. It examines the effects of optimized attachments and interproximal reduction (slightly shaving the sides of teeth to create space) on tooth rotation. The trial includes four groups: one using both techniques, one with only attachments, one with only interproximal reduction, and one without any additional methods. It suits adults with crooked canines who are healthy, maintain good oral hygiene, use Invisalign aligners (a type of clear aligner therapy), and do not require surgery or other orthodontic devices. As an unphased trial, this study allows participants to contribute to innovative orthodontic research and potentially benefit from advanced techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dental health and orthodontic treatment, so it's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that these techniques are safe for correcting malocclusion?

Research has shown that both interproximal reduction (IPR) and optimized attachments used with clear aligners are generally safe and well-tolerated. IPR, a common orthodontic technique, creates space between teeth, helping aligners fit better and work more effectively. Studies indicate that patients usually handle IPR well, without significant side effects.

Optimized attachments, small bumps added to teeth, help aligners grip better and improve control over tooth movement, such as rotation. Research indicates these attachments are safe and enhance treatment results.

Using both IPR and optimized attachments together is common in clear aligner therapy. Experts agree this combination can improve overall effectiveness without compromising safety. Overall, clear aligner treatments, including these methods, are considered safe and effective for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for malocclusion because they explore the potential of clear aligners' auxiliaries to enhance orthodontic care. Unlike traditional braces that rely on metal wires and brackets, these treatments use optimized composite attachments and interproximal reduction (IPR) to improve tooth alignment more discreetly. Optimized attachments provide targeted pressure to guide teeth into place, while IPR creates additional space between teeth to aid in correction. This approach offers a less invasive and visually appealing alternative, which could improve patient comfort and satisfaction compared to conventional methods.

What evidence suggests that this trial's treatments could be effective for malocclusion?

Research has shown that clear aligners can straighten teeth as effectively as traditional braces. Studies also indicate that people using clear aligners often experience a better quality of life compared to those with fixed braces. Clear aligners can work quickly and achieve results similar to traditional braces. In this trial, some participants will receive clear aligners with optimized attachments to enhance tooth movement control. Others will undergo interproximal reduction, a technique that creates space between teeth, to further improve how well clear aligners rotate and align teeth. Overall, these methods make clear aligners a promising choice for correcting misaligned teeth. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with good oral hygiene and no periodontal disease, needing Invisalign (SmartTrack) for malocclusion involving rotated canines. Participants must be physically healthy without relevant allergies or medical issues.

Inclusion Criteria

My ethnicity does not affect my eligibility.

I am over 18 years old.

I have all my permanent teeth except for wisdom teeth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment and Randomization

Initial orthodontic records are collected, and participants are randomized into one of the four interventional groups

1 day

1 visit (in-person)

Treatment

Participants receive Invisalign aligners and are instructed on their use. Treatment continues with aligner changes as recommended

6-9 months

Multiple visits (in-person) as needed

Final Assessment

Final records are collected to assess the accuracy of the treatment outcomes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clear Aligners' Auxiliaries

Trial Overview The study compares the effectiveness of optimized attachments, interproximal reduction (IPR), and their combination on improving the rotational position of canine teeth using clear aligners in people with malocclusion.

How Is the Trial Designed?

Group I: Optimized attachments Experimental Treatment 1 Intervention

optimized composite attachments will be added to this arm

Group II: Inter proximal reduction Experimental Treatment 1 Intervention

Interproximal reduction will be performed in this arm

Group III: IPR and optimized attachments Experimental Treatment 1 Intervention

Both Interproximal reduction will be implemented and optimized attachments will be added to this arm

Group IV: Control Active Control 1 Intervention

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

Clear Aligners' Auxiliaries is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Invisalign for:

• Orthodontic treatment for malocclusions
• Teeth straightening
• Rotational corrections

Approved in European Union as Invisalign for:

• Orthodontic treatment for malocclusions
• Teeth straightening
• Rotational corrections

Approved in Canada as Invisalign for:

• Orthodontic treatment for malocclusions
• Teeth straightening
• Rotational corrections

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Clear aligner therapy (CAT), specifically using Invisalign, has been successfully applied to correct a Class II malocclusion with crowding and an open bite tendency, which were previously considered challenging cases.

Recent advancements in technology and practitioner expertise have expanded the applicability of CAT beyond minor spacing and crowding issues to include more complex dental malocclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using clear aligner therapy to correct malocclusion with crowding and an open bite. Harnick, DJ.[2016]

Clear aligners alone are not sufficient to treat all types of malocclusion effectively, with a reported discrepancy of 50% or more between predicted and actual outcomes, often requiring additional adjustments or even a switch to traditional braces.

Incorporating customized adjuncts, such as mini pin-supported devices and innovative appliance designs, can enhance the predictability and effectiveness of clear aligner therapy, allowing for better management of various malocclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized adjuncts with clear aligner therapy: "The Golden Circle Model" explained! Vaid, NR., Sabouni, W., Wilmes, B., et al.[2023]

In a finite element analysis of clear aligner therapy, models without attachments and those with palatal attachments showed greater maxillary incisor movement compared to models with labial or both types of attachments, indicating that palatal attachments may enhance tooth displacement.

Labial attachments provided a biomechanical advantage by reducing uncontrolled tipping of the teeth, although they resulted in higher stress concentrations at the roots compared to other models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of varying attachment positions on palatal displacement of maxillary incisors with clear aligner therapy : A three-dimensional finite element analysis. Ahmed, T., Padmanabhan, S., Pottipalli Sathyanarayana, H.[2023]

Clear aligner treatment (CAT) is effective for correcting mild to moderate malocclusions, but it shows inferior results for severe cases, indicating that it is best suited for less complex orthodontic issues.

While CAT may lead to a greater risk of relapse compared to traditional braces, it is associated with better periodontal health and lower risk of root resorption, making it a comfortable alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of clear aligner treatment compared to fixed appliance treatment: an overview of systematic reviews. Yassir, YA., Nabbat, SA., McIntyre, GT., et al.[2022]

In a study of 72 adolescents with Class I and II malocclusions, treatment with clear aligners (CAT) was completed on average 3 months faster than treatment with fixed appliances (FAT), with significantly fewer scheduled visits (16 vs 24).

Despite the differences in treatment duration and visit frequency, the efficacy of CAT and FAT was similar, as indicated by comparable discrepancy index and cast radiograph evaluation scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome assessment of orthodontic clear aligner vs fixed appliance treatment in adolescents with moderate to severe malocclusions. Chou, B., Nickel, JC., Choi, D., et al.[2023]

Clear aligner treatment (CAT) is effective in aligning and leveling dental arches, particularly in controlling anterior tooth intrusion, with a mean intrusion of 0.72 mm observed across studies.

However, CAT struggles with controlling certain movements, such as anterior extrusion and rotation of rounded teeth, indicating limitations in its efficacy for specific orthodontic adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Rossini, G., Parrini, S., Castroflorio, T., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39947778/

EFFECTIVENESS OF CLEAR ORTHODONTIC ALIGNERS ... The patients quality of life at 6 months was significantly better for clear aligners compared with fixed appliances (MD = -4.37, 95% CI, -6.93 to -1.80, P < .

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1532338224001313

EFFECTIVENESS OF CLEAR ORTHODONTIC ALIGNERS ... Clear aligners were not significantly more effective than fixed appliances for simple malocclusions treated on nonextraction basis.

3. progressinorthodontics.springeropen.com progressinorthodontics.springeropen.com/articles/10.1186/s40510-025-00575-1

Indications and limits of clear aligner therapy: an international ... According to the panelists, clear aligners demonstrate better performance than conventional fixed appliances in two areas: they reduce root ...

4. cureus.com cureus.com/articles/359709-clinical-effectiveness-of-clear-aligner-therapy-during-interceptive-orthodontic-treatment-in-adolescent-patients-a-systematic-review-and-meta-analysis.pdf?email=

Clinical Effectiveness of Clear Aligner Therapy During ... Aligners corrected malocclusions within short periods and achieved outcomes comparable to traditional methods. Patients and parents highly ...

5. nature.com nature.com/articles/s41368-025-00350-2

Expert consensus on the clinical strategies for orthodontic ... This expert consensus discusses case selection and grading of treatment difficulty, principle of clear aligner therapy, clinical procedures and potential ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S107387462500026X

Interproximal reduction with clear aligner therapy This scoping review aimed to collate and synthesise the evidence regarding the use of IPR with CAT, focusing on its applications, effects, and perceptions ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11032144/

The Role of Interproximal Reduction (IPR) in Clear Aligner ... Interproximal reduction (IPR) has become a standard practice in orthodontic treatment, particularly in the clear aligner therapy.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06418984

Clinical Trial to Compare Clear Aligners' Auxiliaries on ... Also called a data safety and monitoring board, or DSMB. ... Both Interproximal reduction will be implemented and optimized attachments will be added to this arm.

9. mdpi.com mdpi.com/2304-6767/13/10/440

Evaluating the Clinical Success of Clear Aligners for ... Interproximal reduction is a common adjunct in clear aligner therapy, intended to create space, reduce interproximal resistance, and facilitate tooth alignment ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904224/

Expert consensus on the clinical strategies for orthodontic ... However, clear aligners are not recommended for patients with clinically short crowns, requiring extensive mesial movement of the posterior ...