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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Clear Aligner Therapy?

Research shows that clear aligners are effective in improving dental alignment and are increasingly popular due to their aesthetic appeal. However, the success of the treatment depends on patient cooperation and the skill of the clinician. ^{1 2 3 4 5}

Is clear aligner therapy generally safe for humans?

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 MAUDE database contains reports of these events, and manufacturers have taken steps to address them. ^{6 7 8 9 10}

How does Clear Aligner Therapy differ from other orthodontic treatments?

Clear Aligner Therapy is unique because it uses a series of removable, clear plastic trays to gradually move teeth without the need for metal braces or surgery. This treatment is more comfortable, esthetic, and allows for easy adjustments and dental procedures during the course of treatment. It is also flexible, as treatment can be paused and resumed if needed. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Steven Lindauer

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An objective system for appraising clear aligner treatment difficulty: clear aligner treatment complexity assessment tool (CAT-CAT). [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Perception of Need for Further Refinement in a Clear Aligner Treatment among Orthodontists, Dentists and Laypeople: A Retrospective Study. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Effectiveness and predictability of treatment with clear orthodontic aligners: A scoping review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of clear aligner therapy for orthodontic treatment: A systematic review. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Invisalign appliance: aesthetic and efficiency. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Clear aligner therapy: risks and clinical strategies]. [2020]

7. India 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. [2017]

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

Risk Factors of Composite Attachment Loss in Orthodontic Patients during Orthodontic Clear Aligner Therapy: A Prospective Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The effect of passive clear aligners on masticatory muscle activity in adults with different levels of oral parafunction. [2023]

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

Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database. [2017]

11. China pubmed.ncbi.nlm.nih.gov

[Guidelines for clear aligner orthodontic treatment (2021)]. [2021]

12. China pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Anterior crossbite correction with a series of clear removable appliances: a case report. [2016]

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

Clear aligner: an efficient, esthetic, and comfortable option for an adult patient. [2021]

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

Anterior Crossbite and Crowding Correction with a Series of Clear Aligners Involving Lower Incisor Extraction: "The Clear Way" Case Report. [2016]