RecruitingNAINTERVENTIONAL

The Effectiveness of Early Intervention to Correct the Position of PDC:s

This study focuses on a common problem where some children's permanent 'adult' canine teeth in the upper jaw don't fully grow into their correct spot, sometimes getting stuck in the roof of the mouth. This can lead to problems like damaging nearby teeth. We are trying to find out if early treatments can make a difference. We're comparing two ways to help these teeth: removing the baby canine tooth or using methods to create more space in the mouth. The main goal is to see if these early steps can stop children from needing more involved treatments, like surgery or long-term braces, further down the line.

At a glance

Status

Recruiting

Phase

Sponsor

Göteborg University

Enrolment target

324

Start

01 Oct 2024

Estimated completion

30 Dec 2027

Ectopic Tooth Eruption Palatal Expansion Technique Randomized Clinical Trial

What is this study about?

Around 2 to 3 out of every 100 children experience a problem where one or both of their top 'adult' canine teeth, the fangs or eye teeth, don't grow into place properly. Instead, these teeth can get stuck in the roof of the mouth. This is a common issue and is often called a 'palatally displaced canine'. When these teeth are stuck, they can cause other problems, like potentially harming the roots of neighbouring teeth or pushing other teeth out of alignment.

Currently, some dentists suggest removing the baby canine tooth at the right time, hoping this will allow the adult canine to naturally correct its position and grow in properly. Another idea is to create more room in the mouth for the adult tooth to come down, possibly using a special plate or brace. Both of these approaches aim to guide the tooth into its correct spot without needing major treatment later on. If these simpler methods work, it means children can avoid more complex procedures like an operation to uncover the tooth and then needing extensive brace treatment for a long time.

This study is important because we want to find out for sure if these early interventions actually work. We know that the evidence for current practices isn't very strong, and more research is needed. By comparing no treatment, removing a baby tooth, and making more space, we hope to discover the best and least invasive way to help children with this tooth problem, making it better for them and for the healthcare system.

Key takeaways

A common problem where adult canine teeth get stuck in the roof of the mouth.
The study tests if early treatments can prevent later surgery or long braces.
Children will be randomly assigned to three groups: baby tooth removal, space creation, or no early treatment.
The study lasts 18 months and carefully monitors tooth development.
Aims to find the most effective and least invasive treatment option.

Who may be eligible?

This study is looking for children between 10 and 12 years old. To be included, a dentist needs to suspect that one or both of their upper 'adult' canine teeth aren't growing in properly. This might be noticed because the tooth can't be felt through the gum, or because one side of the mouth shows a much different way the tooth is coming through compared to the other. Special X-rays will be taken to confirm that the adult canine tooth is indeed stuck in the roof of the mouth.

However, not everyone with a displaced canine tooth can join. Children will not be able to take part if their tooth is displaced towards the cheek (rather than the roof of the mouth), or if they are missing certain other adult incisor teeth. Also, if a child has very severe overcrowding in their upper jaw, or any other related serious dental problem, they won't be suitable for this particular study. The study also excludes teeth that are very severely stuck.

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.

Is your child between 10 and 12 years old?
Does a dentist suspect one or both of their upper adult canine teeth aren't growing in properly (stuck in the roof of the mouth)?
Is the tooth NOT displaced towards the cheek?
Does your child NOT have very severe overcrowding or other major dental problems in the upper jaw?

Answer every question to see your result.

What does participation involve?

If you or your child decides to take part in this study, they will be randomly assigned to one of three groups, like drawing lots. One group will have a baby canine tooth removed. Another group will receive treatment to create more space in the mouth for the adult tooth. The third group will not have any early intervention, which means they will be monitored. All participants will have their teeth and progress checked regularly over 18 months. This will involve visits to the orthodontic department in Sheffield, Germany, or Sweden. The main goal is to see if surgery is needed after 18 months, but we'll also look at things like how much it costs and if there's any damage to nearby teeth.

Potential risks and benefits

Participating in this study might offer the benefit of potentially avoiding more involved surgery and long-term brace treatment if an early intervention works for your child. However, there are potential risks, as with any dental procedure. Removing a baby tooth has minor risks, and creating space might involve temporary discomfort. There's also the chance that the chosen early intervention might not work. Remember, you can withdraw from the study at any time without giving a reason, and this will not affect your child's future dental care.

Locations (3)

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

Private practice
Verified postcode
Traben-Trarbach, Germany· Not yet recruiting
Gothenbrug University
Verified postcode
Gothenburg, Sweden· Recruiting
University of Sheffield
Verified postcode
Sheffield, United Kingdom· Not yet recruiting

Common questions

What is a 'palatally displaced canine'?

It's when one of the upper 'adult' canine teeth (the pointy ones) gets stuck in the roof of the mouth and doesn't grow into place properly.

Why is this study important?

It helps us find out if simple early treatments, like removing a baby tooth, can prevent children from needing bigger surgeries or long-term braces later on.

Will my child need surgery if they join this study?

The study aims to see if early treatments avoid surgery. If your child is in the 'no early treatment' group, or if the early treatment doesn't work, normal dental care will be provided later, which might include surgery if needed.

What kind of treatments are being tested?

We're looking at removing the baby canine tooth, or using devices to create more space for the adult tooth to grow in.

How long will the study last?

Children will be followed for 18 months after they start the study.

How to find out more

Farhan Bazargani, DDS, PhD

farhan.bazargani@gu.se +46707546107 Official trial record

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