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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Clear Aligners' Auxiliaries for Malocclusion?

Clear aligner therapy (CAT) has been shown to successfully correct minor spacing and crowding, and recent advances have expanded its use to more complex cases like open bites. However, the effectiveness of CAT alone can be limited, and adding customized adjuncts (extra tools or techniques) can improve treatment outcomes. ^{1 2 3 4 5}

How is the Clear Aligners' Auxiliaries treatment different from other treatments for malocclusion?

Clear Aligners' Auxiliaries (Invisalign) are unique because they use a series of plastic aligners to gradually move teeth, and recent advancements allow them to address more complex cases like open bites. Additionally, customized adjuncts can be added to improve treatment predictability, making them a flexible and innovative option compared to traditional fixed braces. ^{1 2 3 4 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of clear aligner treatment compared to fixed appliance treatment: an overview of systematic reviews. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Customized adjuncts with clear aligner therapy: "The Golden Circle Model" explained! [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Outcome assessment of orthodontic clear aligner vs fixed appliance treatment in adolescents with moderate to severe malocclusions. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. [2022]

6. Germany 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. [2023]