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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the comfort and effectiveness of the Invisalign® system for individuals with an overbite. Researchers are examining the fit and function of the aligners when used with special occlusal blocks, which help adjust the jaw. Participants will receive the Invisalign® System with mandibular advancement, a method to move the lower jaw forward. The trial seeks individuals eligible for Invisalign treatment who do not have conditions such as active tooth decay or gum disease. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance orthodontic treatments for future patients.

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.

What prior data suggests that the Invisalign® System with Mandibular Advancement is safe for use?

Research has shown that the Invisalign® System with Mandibular Advancement is generally easy to use. In studies, patients using Invisalign® aligners experienced an average reduction of 1.5 mm in overbite, indicating effective and manageable treatment for most users. Although these studies do not provide specific details on side effects, the widespread use of the Invisalign® System for straightening teeth suggests its safety. As a dental device, not a medication, the safety concerns differ. Most reports focus on its effectiveness in moving teeth rather than safety issues, suggesting that serious side effects are unlikely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Invisalign® System with Mandibular Advancement for treating overbite because it offers a non-invasive alternative to traditional braces and jaw surgery. Unlike standard braces that require brackets and wires, Invisalign® uses clear aligners that are less noticeable and more comfortable. The unique feature here is the mandibular advancement capability, which simultaneously aligns teeth and repositions the jaw, addressing both dental alignment and jaw positioning in one go. This dual action could lead to quicker treatment times and improved patient comfort compared to existing methods.

What evidence suggests that the Invisalign® System with Mandibular Advancement is effective for overbite?

Research has shown that the Invisalign System with jaw advancement can effectively treat Class II malocclusion, a misalignment of the teeth, in growing children. In a clinical trial with forty patients, this treatment significantly reduced the gap between the top and bottom teeth, known as overjet, and also reduced overbite. Another study found that the results of using Invisalign with jaw advancement are similar to traditional methods like Clark Twin Block appliances. However, one study reported less improvement, with the overjet decreasing from an average of 6.49mm to 4.61mm. Overall, evidence suggests that this treatment can be effective, but results may vary. Participants in this trial will receive the Invisalign System with Mandibular Advancement to evaluate its effectiveness in treating overbite. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1.

investor.aligntech.com

investor.aligntech.com/news-releases/news-release-details/align-technology-announces-invisalignr-system-mandibular-0

Press Release

“Treatment outcomes with the Invisalign System with mandibular advancement featuring occlusal blocks are on par with traditional Clark Twin ...

2.

invisalign.com

invisalign.com/provider/align-digital-platform/mandibular-advancement

Mandibular Advancement | Invisalign Provider

A clinical trial with forty patients demonstrated Invisalign treatment with mandibular advancement is effective in treating Class II malocclusion in growing ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12110437/

Mandibular Advancement vs. Class II Elastics

Both treatment modalities significantly reduced overjet and overbite from T1 to T2. Conclusions: The EL and MA appliances effectively advanced ...

4.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K232233.pdf

September 26, 2023 Align Technology, Inc. John Ray ...

The Invisalign System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed. (primary and permanent), or.

5.

kevinobrienorthoblog.com

kevinobrienorthoblog.com/a-new-study-shows-invisalign-mandibular-advancement-is-not-effective/

A new study shows Invisalign Mandibular Advancement is ...

A new study shows Invisalign Mandibular Advancement is not effective. · The treatment reduced the initial overjet from a mean of 6.49mm to 4.61mm ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11365740/

Does Invisalign Outperform Fixed Appliance in Treating ...

They observed that clear aligners produced a median reduction of 1.5 mm in overbite for deep bite cases, primarily through the repositioning of ...

7.

aligntech.com

aligntech.com/about/clinical_evidence

The science behind the Invisalign® smile

Cephalometric analyses indicated that Invisalign® aligners improved the overbite in these patients with a median deepening of 1.5mm. Overbite correction was ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06651944

Invisalign® System with Mandibular Advancement

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...

9.

mdpi.com

mdpi.com/2304-6767/13/11/517

Cephalometric, PAR and 3D Molar Displacement Outcomes

This retrospective study assessed the effectiveness of the Invisalign® Mandibular Advancement (MA) System in growing patients with mandibular retrognathia.