RecruitingNAINTERVENTIONAL

Invisalign® System with Mandibular Advancement

This research is focused on a specific type of clear brace system called Invisalign, which is designed to help children and teenagers whose lower jaw is set back. This condition is sometimes called an 'overbite' where the top teeth stick out too far. The Invisalign system being tested includes special small blocks to help guide the jaw forward. The main aim of the study is to understand how comfortable these special aligners are for the young people wearing them and how well they fit. Researchers also want to check that the innovative blocks within the aligners are doing their job correctly to improve the bite.

At a glance

Status

Recruiting

Phase

Sponsor

Align Technology, Inc.

Enrolment target

Start

14 Feb 2024

Estimated completion

31 Dec 2026

Class II Malocclusion Mandibular Advancement Mandibular Retrognathism Excessive Overjet

What is this study about?

This study is looking into a particular way of fixing bite problems in young people aged 10 to 16. If someone has a severe 'overbite' where their top teeth stick out a lot because their lower jaw is too far back, it can cause problems with chewing, speaking, and even how their face looks. This condition is medically called 'Class II Malocclusion' or 'Mandibular Retrognathism' with 'Excessive Overjet'. Traditionally, fixed braces or even surgery might be used, but clear aligners are a newer option.

The specific treatment being studied here is the Invisalign system, which uses clear, removable aligners instead of traditional metal braces. What makes this special is the addition of 'mandibular advancement features', which are small blocks built into the aligners. These blocks are designed to gently push the lower jaw forward, correcting the bite over time. The study aims to see how well these special aligners work and how comfortable they are for the young people wearing them.

By taking part, individuals would help doctors understand if this particular type of Invisalign with jaw-moving blocks is a good and comfortable option for fixing these bite issues. The results could help improve orthodontic treatment choices for many young people in the future.

Key takeaways

Study tests new clear braces (Invisalign) with special features for bite problems.
Aims to fix 'overbites' where the lower jaw is set back.
Focuses on comfort and how well these special aligners work.
For young people aged 10 to 16.
Helps improve future treatment choices for jaw alignment.

Who may be eligible?

This study is looking for children and teenagers between 10 and 16 years old.

To join, they must have a bite condition where their lower jaw is set back and their top teeth stick out. Their dentist or orthodontist would need to confirm that this specific Invisalign treatment is suitable for their particular bite problem.

However, some conditions would mean someone couldn't take part. This includes if their teeth aren't suitable for the device, if they're allergic to the materials used in the aligners, or if they have certain health issues like active tooth decay, gum disease, jaw joint problems (TMD), a condition called hereditary angioedema (HAE), or epilepsy. Pregnant individuals also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 10 and 16 years old?
Has a dentist said your lower jaw is too far back, causing an 'overbite'?
Have you been told this specific type of Invisalign might be suitable for you?
Are you currently not pregnant?
Do you have no severe gum disease, active tooth decay, or certain other health conditions?

Answer every question to see your result.

What does participation involve?

The details about what is involved in this study are not fully described in the summary provided. However, generally, taking part in an orthodontic study like this would typically involve regular visits to the clinic over a period of time to get new aligners and have your progress checked. You would wear the Invisalign aligners as instructed, usually most of the day and night, removing them only to eat, drink, and brush your teeth. The aligners are changed every one or two weeks. Assessments would likely include scans, photos, and possibly impressions of your teeth, along with questions about your comfort. The total duration of similar treatments can vary widely, from several months to a couple of years.

Potential risks and benefits

There are several potential benefits to taking part in this study. You would receive a specific orthodontic treatment which aims to improve your bite and smile, and you would be closely monitored by dental professionals. Your participation would also contribute important information to help improve treatment options for other young people. Potential risks are generally similar to those of standard orthodontic treatment, such as temporary discomfort, speech changes, or irritation from the aligners. There's also the chance the treatment might not work as expected for every individual. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Astra Orthodontics
Verified postcode
Richmond, Canada· Recruiting
MacKenzie Orthodontics
Verified postcode
Saint John, Canada· Recruiting
Discover Orthodontics
Verified postcode
Brampton, Canada· Recruiting

Common questions

What kind of bite problem is this study looking at?

It's for children and teenagers whose lower jaw is set back, causing their top front teeth to stick out a lot, sometimes called an 'overbite'.

What are 'occlusal blocks'?

These are small, specially designed parts built into the Invisalign clear aligners that help gently guide the lower jaw forward to improve the bite.

Will I have to wear metal braces?

No, this study is specifically about using the clear, removable Invisalign aligners, not traditional metal braces.

How old do I need to be to join?

You need to be between 10 and 16 years old to be considered for this study.

What if I decide I don't want to be in the study anymore?

You have the right to leave the study at any point, and it won't affect any future medical care you might need.

How to find out more

Allison Mossing

amossing@aligntech.com 4083940304 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.