Not yet recruitingNAINTERVENTIONAL

Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment

This study explores new ways to keep young people's mouths healthy while they wear fixed braces. When you have braces, it's common for tiny germs (microbes) in your mouth to get out of balance, even if you brush well. This is because braces can make it harder to clean your teeth and create new spots for germs to hide. We're comparing two groups: one receiving standard care and another receiving personalised prevention. The personalised approach involves understanding each person's unique 'mouth health signature' to give them tailored advice and support. We hope this personalised care can stop mouth imbalances from happening. If successful, this idea could help many more patients, not just those with braces, keep their mouths healthy.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

01 Jun 2025

Estimated completion

06 Jun 2028

Orthodontics

What is this study about?

Imagine your mouth is like a tiny garden, full of different plants and creatures living in harmony. While you're wearing braces, it can be a bit like shaking up that garden – some parts might grow too much, and others might not grow enough. This imbalance, called dysbiosis, is quite common when you have braces because they can make it tricky to clean every spot properly, giving germs new places to hide.

This study is trying to find the best way to keep your mouth garden healthy and balanced during orthodontic treatment. We're looking at whether giving personalised advice and prevention – based on your mouth's unique 'biological signature' (like a fingerprint of your mouth germs and immune system) – works better than the usual care. Our goal is to create a special risk profile for each person, which would help us give them the most effective prevention tips, tools, and follow-up schedule.

We're focusing on young people with braces because they visit the dentist regularly, which makes it easier to test new preventative approaches. The main idea is to help healthy patients stay healthy, by finding ways to stop these mouth imbalances (dysbiosis) from developing in the first place. If we find that personalised prevention works well, this approach could eventually be used to help lots of different patients keep their mouths healthy, not just those with braces.

Key takeaways

This study aims to improve mouth health for young people with braces.
It tests if personalised advice works better than standard care.
The goal is to prevent mouth imbalances (dysbiosis) during orthodontic treatment.
It could lead to better prevention for many patients in the future.
Participants will have regular orthodontic appointments, making it easier to study.

Who may be eligible?

This study is looking for young people aged 12 to 20 who need to get fixed braces. You'll need to have all your adult teeth.

There are certain reasons why you might not be able to join. For example, if you smoke, have lots of fillings that are crowded together, untreated tooth decay, or teeth with a lack of mineralisation. Also, if you have certain medical conditions, a weakened immune system (either from birth or something you developed), are taking medicines that affect your immune system, or are taking probiotics, this study might not be suitable for you. Finally, if you're on any other treatment that might affect your mouth health, you might not be able to take part.

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 12 and 20 years old?
Do you need to get fixed braces?
Do you have all your adult teeth?
Do you currently smoke or use tobacco?
Do you have any serious ongoing medical conditions, or a weakened immune system?
Are you taking any medications that affect your immune system or mouth health, or are you taking probiotics?

Answer every question to see your result.

What does participation involve?

The detailed description of participation is not available in the provided text. However, based on the summary, if you take part in this study, you would likely be assigned to one of two groups. One group would receive standard dental care during your orthodontic treatment. The other group would receive standard care plus a personalised prevention plan tailored to your mouth's specific needs. This personalised plan might involve special advice or methods for keeping your mouth healthy and more frequent check-ups. As the study focuses on patients who have regular orthodontic appointments, any additional visits or assessments would likely be integrated into your existing treatment schedule. The study aims to follow young patients throughout their orthodontic treatment.

Potential risks and benefits

The potential benefits of taking part include contributing to research that could improve how we prevent mouth problems during orthodontic treatment, potentially leading to better long-term oral health for yourself and others. If you're in the personalised prevention group, you might receive enhanced care that could lead to a healthier mouth during your braces journey. As with any study, there could be unforeseen risks, though none are specifically mentioned. The study involves young people and seems focused on prevention through advice and monitoring, suggesting low direct risk. You always have the right to withdraw from the study at any time, for any reason, without it affecting your regular orthodontic care.

Locations (2)

Rance Orthodontics Practice
Verified postcode
Dinan, France
Nice university hospital
Verified postcode
Nice, France

Common questions

What kind of braces are involved?

This study is for young people who are getting fixed braces, which are the ones that stay on your teeth for the duration of your treatment.

What does 'personalised prevention' mean?

It means getting special advice and care that's tailored just for you, based on unique information about the germs and immune system in your mouth, to help keep it healthy.

Will my regular dental care be affected?

No, your regular orthodontic treatment will continue as normal. The study is about seeing if extra, personalised prevention helps alongside your usual care.

Why is this study only for young people?

The study focuses on young patients primarily because they have fixed braces and regular appointments, which makes it easier to provide and monitor different prevention methods.

What is 'dysbiosis'?

Dysbiosis is when the balance of tiny germs (microbes) in your mouth gets disturbed, which can sometimes lead to problems like gum issues or decay.

How to find out more

laurence LUPI, PUPH

laurence.lupi@univ-cotedazur.fr 3392033272 Official trial record

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