Clear Aligners for Orthodontic Appliance Complications

Overseen By Alexis Catalano

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Poor compliance, Surgery, Extractions, Missing teeth, Crossbite, others

Compensation: Varies

Number of Visits: Unknown

Duration: 20-25 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of clear aligners to evaluate their effectiveness in addressing dental issues compared to the standard Invisalign treatment. It specifically examines how well these aligners adjust maxillary lateral incisors (the teeth next to the front teeth) when they need to move outwards. Participants should have used either Comprehensive Invisalign or Invisalign Teen, with less than 6 mm of crowding or spacing in their upper teeth. Those who have used aligners and noticed that their upper teeth are not tracking as expected may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore new aligner options and improve dental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that clear aligners are generally safe for straightening teeth. Many people prefer them for their comfort and appearance compared to metal braces. However, like any treatment, some side effects may occur. Minor issues such as itching, swelling, or a rash might arise. If these occur, consulting a dentist promptly is important.

Reports have also noted that aligners may not fit securely, a condition known as attachment loss. These issues are usually not serious and can be managed with a dentist's assistance. Overall, most people find clear aligners easy to use and effective for straightening teeth. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new designs of clear aligners specifically beveled at the gum line to potentially reduce common orthodontic complications. Unlike traditional clear aligners that follow a one-size-fits-all approach, these experimental aligners are customized with precise gingival beveling measurements of 1x1x3mm, 1x1x4mm, and 1x1x5mm. This unique design aims to improve comfort and effectiveness in managing tooth extrusion and other alignment issues. The control group uses Invisalign's current optimized attachments for extrusion, setting a benchmark to evaluate the innovations in these new aligner designs.

What evidence suggests that this trial's clear aligner treatments could be effective for orthodontic appliance complications?

Research has shown that clear aligners, such as Invisalign, effectively straighten teeth and achieve desired orthodontic results. Studies have found that small attachments on aligners enhance their effectiveness by aiding tooth movement. For example, Invisalign achieved about 78.9% of the planned change in tooth rotation, demonstrating that clear aligners can make specific adjustments to teeth. In this trial, participants will receive aligners with different gingivally beveled designs (1x1x3mm, 1x1x4mm, or 1x1x5mm) to improve fit and comfort, potentially leading to better outcomes. Overall, clear aligner therapy is a proven method for straightening teeth, offering a comfortable and less noticeable alternative to traditional braces. ^{1 3 5 6 7}

Who Is on the Research Team?

Steven Lindauer

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals undergoing orthodontic treatment with Invisalign who need to move their upper lateral incisors. There are no specific inclusion or exclusion criteria provided, so it's likely open to a broad range of patients using this type of clear aligner.

Inclusion Criteria

Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment

Patients confirm good compliance throughout the study period

I am 12 or older and can consent, or my guardian can.

Exclusion Criteria

Patients with anterior crossbite

Midcourse intervention to improve tracking such as a bootstrap

Missing teeth other than third molars

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clear aligner treatment with different attachment sizes for maxillary lateral incisor extrusion

20-25 weeks

Weekly aligner changes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clear Aligner Therapy

Trial Overview

The study is testing the effectiveness of different sizes (3mm, 4mm, and 5mm) of gingivally beveled attachments on clear aligners in moving maxillary lateral incisors. It will compare predicted tooth positions with actual outcomes after treatment.

How Is the Trial Designed?

Group I: Gingivally beveled 1x1x5mm aligners Experimental Treatment 2 Interventions

Each set of aligners would be worn for a week/gingivally beveled 1x1x5mm

Group II: Gingivally beveled 1x1x4mm aligners Experimental Treatment 2 Interventions

Each set of aligners would be worn for a week/gingivally beveled 1x1x4mm

Group III: Gingivally beveled 1x1x3mm aligners Experimental Treatment 2 Interventions

Each set of aligners would be worn for a week/gingivally beveled 1x1x3mm

Group IV: Control/optimized for extrusion.aligners Placebo Group 2 Interventions

The control will be Invisalign's optimized attachment which will be specifically optimized for extrusion.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

Clear aligner treatment has expanded its use from just correcting crowding or spacing to addressing moderate malocclusions, including both extraction and non-extraction cases, due to advancements in biomaterials and biomechanics.

Orthodontists must understand the strengths and limitations of clear aligners, particularly in three-dimensional tooth movement control, and should actively modify digital treatment plans based on their clinical experience to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advantages and disadvantages of clear aligner treatment in orthodontics]. Liu, Y.[2018]

A retrospective analysis of 173 medical device reports related to the Invisalign system revealed that 97.7% were adverse events, with 26% classified as serious or life-threatening, highlighting potential safety concerns associated with its use.

The most common serious adverse events included difficulty breathing, anaphylaxis, and throat swelling, indicating that healthcare providers should be vigilant and prepared to manage these reactions in patients using Invisalign.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database. Allareddy, V., Nalliah, R., Lee, MK., et al.[2017]

Over a 5-year period, 175 adverse events and reactions (AERs) related to sequential aligners were reported in the FDA's MAUDE database, with a significant portion (73.71%) being mandatory reports from manufacturers.

Common AERs included allergic reactions (18.29%), with serious cases such as anaphylaxis (11.43%) and angioedema (2.29%), as well as other issues like gastrointestinal problems and neuromuscular symptoms, highlighting the need for awareness of potential risks associated with sequential aligner use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events with use of orthodontic sequential aligners as reported in the manufacturer and user facility device experience database. Thavarajah, R., Thennukonda, RA.[2017]

Citations

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withpower.com

withpower.com/trial/clear-aligners-for-orthodontic-appliance-complications-4ca4f

Clear Aligners for Orthodontic Appliance Complications

Clear aligner therapy is generally considered safe, but there are some risks and adverse events reported, such as attachment loss and other reactions. The FDA's ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12485647/

Clear Aligner Attachments: A Comprehensive Review - PMC

This review explores the biomechanical role of attachments in clear aligner therapy and evaluates their effectiveness in facilitating various ...

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turkjorthod.org

turkjorthod.org/pdf/26a6643d-3380-4766-8ed8-4703e5d7d038/articles/TurkJOrthod.2025.2025.7/177-189.pdf

Clear Aligner Attachments: A Comprehensive Review

This review explores the biomechanical role of attachments in clear aligner therapy and evaluates their effectiveness in facilitating various ...

4.

bmcoralhealth.biomedcentral.com

bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-06012-3

Evaluating the effectiveness of clear aligner therapy in ...

This retrospective study aims to evaluate the effectiveness of clear aligners in leveling the CoS in premolar extraction and non-extraction patients.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0889540625001581

Efficacy of planned root torque changes of instanding ...

1. The Invisalign appliance achieved 78.9% of the planned root torque change in patients with an IMLI. · 2. The mean pretreatment, planned, and achieved IMLIs ...

6.

springcreekdentistry.com

springcreekdentistry.com/blog/risks-complications-clear-aligners-invisalign/

Risks and Complications of Clear Aligners

Symptoms may include itching, swelling, or a rash. If you suspect you have an allergy to your aligners, consult your dentist immediately. You ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11065214/

Clear aligner's adverse effects: A systematic review protocol

This study aims to investigate the potential adverse effects and their frequency among orthodontic patients wearing clear aligners.