Active not recruitingNAINTERVENTIONAL

Clear Aligners for the Treatment of Dental Malocclusion in OI

This study is investigating a new way to straighten teeth for people with Osteogenesis Imperfecta (OI), a condition that makes bones fragile. Many individuals with OI also have misaligned teeth and jaws, which can be difficult to treat with traditional braces due to a related condition called Dentinogenesis Imperfecta (making teeth fragile). We're exploring clear aligners, like Invisalign, as a less invasive option. The goal is to see if these clear aligners are safe and effective for treating mild to moderate teeth misalignment in people with OI who haven't had braces before. This research, happening at three universities, could lead to new, safer guidelines for dental care in the OI community.

At a glance

Status

Active not recruiting

Phase

Sponsor

Baylor College of Medicine

Enrolment target

Start

01 Aug 2022

Estimated completion

01 Dec 2027

Osteogenesis Imperfecta

What is this study about?

Osteogenesis Imperfecta (OI) is a condition that affects your bones, making them more likely to break. But did you know it can also affect your teeth and jaws? Many people with OI experience their teeth not lining up properly, which can make it hard to eat, speak, or even feel confident about their smile.

Treating misaligned teeth in people with OI can be tricky. Often, people with OI also have a condition called Dentinogenesis Imperfecta, which makes their teeth weaker and more fragile. This means traditional metal braces, which often involve gluing brackets onto the teeth, might not be the best option.

This study is looking at a different kind of treatment: clear aligners, like Invisalign. These are custom-made clear trays that gently move your teeth into position. They're less noticeable than braces and don't involve sticking anything directly onto your teeth. Our research aims to find out if these clear aligners are a safe and effective way to help people with OI achieve a straighter smile. If successful, this could offer a valuable new treatment option that is widely available.

Key takeaways

This study is testing clear aligners (like Invisalign) for teeth straightening in people with Osteogenesis Imperfecta (OI).
It aims to find a safer and more effective orthodontic option for OI patients, especially those with fragile teeth.
Participants must have OI, be aged 12-40, and have mild to moderate teeth misalignment without prior brace treatment.
The research will help create new guidelines for dental care in the OI community.
Taking part means you could get your teeth straightened and contribute to important medical research.

Who may be eligible?

We are looking for people aged between 12 and 40 who have been diagnosed with Osteogenesis Imperfecta (OI). Your teeth should be misaligned, but not severely so. You also need to have enough healthy adult teeth to be able to have orthodontic treatment.

There are some reasons why you might not be able to join the study. For example, if you've already had braces, Invisalign, or other orthodontic treatment in the past, or if your teeth misalignment is so severe that it would need surgery to fix. We also cannot include you if you have certain other dental problems like serious gum disease, or if you are taking certain medications that might interfere with the treatment (other than common bone-strengthening medications called bisphosphonates). Pregnant individuals 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.

Do you have a diagnosis of Osteogenesis Imperfecta (OI)?
Are you between 12 and 40 years old?
Are your teeth a bit crooked, but not severely so (mild to moderate)?
Have you never had braces, Invisalign, or other teeth-straightening treatment before?
Do you have enough healthy teeth for orthodontic treatment to be possible?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several visits to one of the study sites. During these visits, the research team will assess your teeth and jaw alignment. You would then receive a series of custom-made clear aligners (like Invisalign trays) that you would wear for most of the day, changing them regularly as instructed. The study will monitor how well the aligners are working and make sure they are safe for you. The exact number of visits and the full duration of your participation will depend on your individual treatment plan, but the main part of the study involves receiving and wearing the aligners.

Potential risks and benefits

Participating in this study might offer you the benefit of having your teeth straightened using a less invasive method than traditional braces, which could improve your smile and bite. You would also be helping to advance medical knowledge for others with OI. Like any medical treatment, there could be some risks, although clear aligners are generally considered safe. These might include temporary discomfort, changes in speech, or mild gum irritation. The study team will explain all potential risks in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (3)

University of California Los Angeles
Verified postcode
Los Angeles, United States
Nidcr/Nih
Verified postcode
Bethesda, United States
McGill University
Verified postcode
Montreal, Canada

Common questions

What are clear aligners?

Clear aligners are custom-made, clear plastic trays that fit over your teeth and gently move them into a straighter position. They are a discreet alternative to traditional metal braces.

Why is this study important for people with OI?

Because people with OI often have delicate teeth due to Dentinogenesis Imperfecta, traditional braces can be challenging. This study explores a potentially safer and more effective way to straighten teeth for them.

How long would I need to wear the aligners?

The exact time varies for each person, but generally, clear aligners are worn for most of the day and night, only removed for eating and brushing.

Where is the study taking place?

This study is happening at three locations: McGill University, University of California Los Angeles, and the National Institute of Dental and Craniofacial Research.

Will I have to pay to be part of this study?

Typically, clinical trials cover the costs associated with the study treatment and visits. This will be fully explained to you before you agree to participate.