RecruitingNAINTERVENTIONAL

A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.

This research is looking at SureSmile clear aligners, which are used to straighten teeth. The main goal is to make sure they are safe and accurate in moving teeth into the correct positions. The study will also compare three different ways the aligners are shaped around the gums (called 'trimline designs') to see which one works best. This is an important step to improve how these aligners help people achieve a straighter smile. It's a study for adults aged 18 and over who have minor to moderate issues with their teeth alignment, commonly known as 'malocclusion'. The study is being carried out in several different locations.

At a glance

Status

Recruiting

Phase

Sponsor

Dentsply Sirona Implants and Consumables

Enrolment target

Start

29 Jan 2026

Estimated completion

01 Feb 2028

Malocclusion

What is this study about?

You know how some people have slightly crooked teeth, or their top and bottom teeth don't quite meet perfectly? This is often called 'malocclusion' by dentists, but for most people, it just means their bite isn't quite right or their smile isn't as straight as they'd like. Nowadays, many people choose clear aligners, like SureSmile, instead of traditional braces to gently move their teeth into better positions. This study is all about making sure these SureSmile aligners are doing their job as safely and accurately as possible.

The researchers are particularly interested in how precise the aligners are at moving teeth. They're also comparing three slightly different shapes or 'designs' of the aligners where they meet the gums. Think of it like comparing three different styles of a shoe to see which one fits and performs best. By doing this, they hope to find out if one design is more effective or comfortable than the others. This kind of research helps improve the treatment options available to fix crooked teeth.

Ultimately, the results of this study could help dentists choose the best SureSmile aligner design for their patients, leading to more predictable and successful treatment outcomes for people looking to improve their smile and bite. It's about constant improvement in dental care, ensuring patients get the best possible results with their aligner treatment.

Key takeaways

This study is testing SureSmile clear aligners for straightening teeth.
It aims to check how safe and accurate the aligners are.
Researchers are comparing three different aligner designs.
It's for adults (18+) with mild to moderate crooked teeth.
Participation involves wearing aligners and attending follow-up checks.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and willing to follow the study plan, including attending follow-up appointments. You also need to have healthy, permanent teeth and a common type of crooked teeth or bite problem that isn't too severe. This means things like slightly crowded or spaced teeth, a slight difference in how your top and bottom teeth meet, or a small gap when you bite down.

However, there are reasons why you might not be able to join. For example, if your teeth problems are very complex, or if you've recently had aligner treatment or are currently having other types of braces. You also can't participate if you have untreated dental problems like gum disease or cavities. Finally, if your specific bite issue would require very big changes that aligners aren't designed to handle.

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 18 years old or older?
Do you have healthy, permanent teeth?
Is your teeth crowding or spacing no more than 6mm?
Is your 'overjet' (front teeth sticking out) no more than 4mm?
Do you have good overall dental health (no untreated cavities or gum disease)?
Have you not had other aligner treatment in the last year?

Answer every question to see your result.

What does participation involve?

The detailed description of participation isn't available in the provided text. However, typically in studies like this, you would: receive SureSmile aligners, wear them as instructed, and attend regular check-ups with your dentist or the study team. These check-ups are to see how your teeth are moving and to make sure the aligners are working correctly. You would likely have X-rays or scans taken at different points. The total duration of your involvement would depend on your specific treatment plan, but usually, aligner treatment can last several months to a couple of years.

Potential risks and benefits

Potential benefits of taking part include receiving SureSmile aligner treatment to straighten your teeth, potentially with a design that could prove to be more effective. You would also be contributing to important research that will help improve dental care for others. As with any medical treatment, there are potential risks, such as temporary discomfort, minor changes to speaking, or needing to wear aligners for longer than expected if teeth don't move as planned. You are always free to withdraw from the study at any time without affecting your standard care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Costanzo Orthodontics
Verified postcode
Fresno, United States· Recruiting
Center for Orthodontic Excellence
Verified postcode
Princeton Junction, United States· Not yet recruiting
J Chichetti PLLC 2
Verified postcode
Huntersville, United States· Recruiting
Brush 365 Dental
Verified postcode
Frisco, United States· Recruiting
Clinica Dental Ortiz Puigpelat
Verified postcode
Barcelona, Spain· Not yet recruiting
The Sanford
Verified postcode
Bexleyheath, United Kingdom· Not yet recruiting

Common questions

What are SureSmile clear aligners?

They are clear, custom-fit plastic trays that gradually move your teeth into a straighter position, often used as an alternative to traditional braces.

What does 'malocclusion' mean?

It's a dental term meaning your teeth are not perfectly straight or your top and bottom teeth don't fit together correctly when you bite down.

What is a 'trimline design' in this study?

It refers to the specific shape or cut of the aligner where it meets your gums. The study is comparing different shapes to see which works best.

Who is paying for this study?

The information provided doesn't state who is funding the study, but it is evaluating the SureSmile aligner product.

Do I have to live near the study location?

Yes, as this is a 'multicenter' study, it's happening in different locations, and you would need to be able to attend appointments at one of those centres.

How to find out more

Freja Freedman

freja.freedman@dentsplysirona.com +46 702107415 Official trial record

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