Invisalign® for Overbite

Recruiting at 2 trial locations

Overseen By Allison Mossing

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Align Technology, Inc.

Disqualifiers: Pregnancy, Active caries, Periodontal disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks

Do I need to stop my current medications for this trial?

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

Is Invisalign® with Mandibular Advancement safe for humans?

Research on Invisalign® with Mandibular Advancement shows it is generally safe, with some studies noting minor changes in teeth alignment, such as overjet and overbite adjustments, which are typical and expected during orthodontic treatments. ^{1 2 3 4 5}

How is the Invisalign® System with Mandibular Advancement unique for treating overbite?

The Invisalign® System with Mandibular Advancement is unique because it combines clear aligners with a feature that advances the lower jaw, which is particularly beneficial for growing patients with a retruded lower jaw. This dual approach not only aligns teeth but also addresses jaw positioning, making it different from traditional braces that typically focus only on teeth alignment. ^{3 4 5 6 7}

Eligibility Criteria

This trial is for individuals with certain dental conditions such as maxillary retrusion, crossbite, overbite, recessed chin, and malocclusion. It's specifically looking at those who might benefit from mandibular advancement using the Invisalign® System.

Inclusion Criteria

I am eligible for Invisalign braces with jaw advancement.

Exclusion Criteria

I am not pregnant and do not have dental issues, hereditary angioedema, epilepsy, or any seizure disorders.

Subject's dentition not compatible with device or allergy to device materials

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Invisalign® System with mandibular advancement featuring occlusal blocks

Up to 2 years

Insertion, interim, and end of study visits

Follow-up

Participants are monitored for comfort, fit, and class II correction after treatment

4-8 weeks

Treatment Details

Interventions

• Invisalign® System with Mandibular Advancement

Trial Overview The study is testing how comfortable and well-fitting the Invisalign® aligners are when they include occlusal blocks designed for mandibular advancement. The engagement of these blocks during treatment will also be evaluated.

Participant Groups

Group I: Invisalign® System with Mandibular Advancement Experimental Treatment 1 Intervention

all participants will receive the study device

Invisalign® System with Mandibular Advancement is already approved in United States, European Union for the following indications:

Approved in United States as Invisalign with Mandibular Advancement for:

• Class II malocclusion
• Retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition

Approved in European Union as Invisalign with Mandibular Advancement for:

• Class II malocclusion
• Retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition

Who Is Running the Clinical Trial?

Align Technology, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Findings from Research

In a study of 75 adults using mandibular advancement devices (MAD) for snoring and sleep apnea, the orthodontic side effects were minimal, with only slight changes in overjet and overbite after 2.5 years.

Patients using hard acrylic devices experienced a greater reduction in overjet compared to those using soft elastomeric devices, suggesting that the design of the device can influence orthodontic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthodontic side-effects of mandibular advancement devices during treatment of snoring and sleep apnoea. Marklund, M., Franklin, KA., Persson, M.[2019]

The reinforced adjustable mandibular advancement appliance (MAA) significantly reduced sleep bruxism (SB) episodes by 39% and 47% at two different protrusion levels compared to baseline, demonstrating its efficacy in managing tooth grinding.

In contrast, the mandibular occlusal splint (MOS) only showed a slight reduction in SB episodes that was not statistically significant, indicating that the MAA may be a more effective alternative for patients with both bruxism and sleep-related breathing disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an adjustable mandibular advancement appliance on sleep bruxism: a crossover sleep laboratory study. Landry-Schönbeck, A., de Grandmont, P., Rompré, PH., et al.[2022]

In a study of 40 skeletal Class II patients treated with Invisalign® Mandibular Advancement, significant improvements in dental and skeletal measurements were observed, particularly in prepubertal (CVM2) and pubertal (CVM3) stages.

The treatment was effective in producing skeletal changes during the pubertal stage, with an annual growth rate of 5.8 mm, while prepubertal treatment mainly resulted in dentoalveolar changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short term dentoskeletal effects of mandibular advancement clear aligners in Class II growing patients. A prospective controlled study according to STROBE Guidelines. Ravera, S., Castroflorio, T., Galati, F., et al.[2021]

The study evaluated the effectiveness of the Invisalign appliance in managing overbite, providing evidence for its use in orthodontic treatment.

Conducted as a retrospective study, the findings contribute to understanding how Invisalign can be a viable option for correcting overbite in patients, although specific data on outcomes and sample size were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Invisalign Appliance Could Be an Effective Modality for Treating Overbite Malocclusions Within a Mild to Moderate Range. Shin, K.[2019]

In a study of 120 adult patients treated with the Invisalign appliance, significant changes in overbite were observed, particularly a median opening of 1.5 mm in deepbite patients and a median deepening of 1.5 mm in open bite patients.

The primary mechanism for these changes was found to be the movement of incisors, indicating that Invisalign effectively manages vertical dimension adjustments in overbite cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of overbite with the Invisalign appliance. Khosravi, R., Cohanim, B., Hujoel, P., et al.[2017]

In a study comparing two groups of adult patients treated with different Invisalign materials, it was found that ClinCheck software often overpredicted the reduction of deep overbites, with only 43.4% of the expected reduction achieved using SmartTrack material with bite ramps, and 55.1% with EX30 material.

The addition of precision bite ramps did not significantly enhance the predictability of overbite correction, indicating that both SmartTrack and EX30 materials have similar limitations in achieving the desired treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictability of overbite control with the Invisalign appliance comparing SmartTrack with precision bite ramps to EX30. Blundell, HL., Weir, T., Byrne, G.[2022]

The InvisalignⓇ system effectively treated severe gingival recession and bone dehiscence in a young woman, demonstrating significant improvements in bone structure and gum health during orthodontic treatment.

Monitoring by a periodontist ensured safety and efficacy, resulting in a reduction of bone dehiscence from 9.4 mm to 3.14 mm and a corresponding improvement in gingival recession, indicating that this approach can promote bone neoformation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Invisalign&#174; aligners in the treatment of severe gingival recession: A case report. Figueiredo, MA., Romano, FL., Feres, MFN., et al.[2021]

References

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

Orthodontic side-effects of mandibular advancement devices during treatment of snoring and sleep apnoea. [2019]

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

Effect of an adjustable mandibular advancement appliance on sleep bruxism: a crossover sleep laboratory study. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Short term dentoskeletal effects of mandibular advancement clear aligners in Class II growing patients. A prospective controlled study according to STROBE Guidelines. [2021]

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

The Invisalign Appliance Could Be an Effective Modality for Treating Overbite Malocclusions Within a Mild to Moderate Range. [2019]

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

Management of overbite with the Invisalign appliance. [2017]

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

Predictability of overbite control with the Invisalign appliance comparing SmartTrack with precision bite ramps to EX30. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness of Invisalign&#174; aligners in the treatment of severe gingival recession: A case report. [2021]