All studies
Active not recruitingNAINTERVENTIONAL

Single Palatal Temporary Anchorage Device for Anterior Open Bite

This research study is looking for young people and adults, aged 12 to 40, who have a dental problem called an 'anterior open bite'. This is when your top and bottom front teeth don't meet when your mouth is closed. We are comparing two different ways to correct this using fixed braces and small, temporary anchors in the mouth. Both methods aim to gently move the back teeth up to allow the front teeth to meet properly. The study will take extra measurements during your routine treatment to see which method is more effective at fixing the open bite and keeping it stable in the long term. Your treatment will be the same high standard regardless of which group you are in.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University of Dundee
Enrolment target
32
Start
01 Apr 2021
Estimated completion
30 Dec 2026

What is this study about?

This study is about a common dental issue called an 'anterior open bite'. This means that when you bite down, your front top and bottom teeth don't touch, leaving a gap. This can sometimes make it harder to bite into certain foods or just affect your smile. Current treatments for this often involve using fixed braces and small, temporary anchor devices, sometimes called TADs.

In this study, we are comparing two widely used methods that involve these temporary anchors. Both methods will use regular braces, but one group will have a single anchor placed in the roof of the mouth, while the other group will have two anchors placed on the sides of the mouth. The goal is the same: to gently move your back teeth upwards, which helps your front teeth come together and correct the open bite.

We want to find out if one of these methods works better than the other, both in fixing the bite initially and in keeping it stable over time. All participants will be receiving standard, good quality orthodontic care that is already available at the clinic, so you will be getting the treatment you need regardless of which group you are in. By taking part, you’ll be helping us understand the best ways to treat open bites for future patients.

Key takeaways

  • This study compares two ways to fix an 'open bite' using braces and temporary anchors.
  • It's for people aged 12-40 with a gap between their front teeth.
  • You'll get standard orthodontic treatment, plus some extra measurements for the study.
  • The study aims to find the most effective and stable way to fix an open bite.
  • You can withdraw at any time without affecting your dental care.

Who may be eligible?

This study is looking for young people and adults aged between 12 and 40 years old. You need to have an 'anterior open bite' where your front teeth don't quite meet, with a gap between 1mm and 6mm. You also need to be planning to get fixed braces to correct your teeth.

There are some reasons why you might not be able to join the study. For example, if you've already had a specific type of tooth extraction (upper first permanent molar extraction) or if you have certain conditions like a cleft lip or palate. Also, if you have a bone disease or are taking medicines that affect your bones, you wouldn't be able to take part.

Finally, if you currently have a active thumb or finger sucking habit, or if you are pregnant or breastfeeding, this study would not be suitable for you. You also need to be able to understand and agree to take part in the study yourself.

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.

  1. Are you between 12 and 40 years old?
  2. Do your front teeth not meet, leaving a small gap (1-6mm)?
  3. Are you going to get fixed braces soon?
  4. Have you not had a specific upper back tooth extracted in the past?
  5. Are you not pregnant or breastfeeding?
  6. Do you not have any bone conditions or active finger/thumb sucking habits?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, your treatment will be carried out at Dundee Dental Hospital's Orthodontic Department. Once you agree to take part, you'll be randomly assigned to one of the two treatment groups, meaning you'll receive one of the two types of temporary anchorage devices along with your fixed braces. Both are routine ways to treat your condition.

Throughout your treatment, we will take some extra records to help us compare the two methods. This might include additional X-rays of your head (called cephalometric radiographs) and extra measurements of your mouth, such as digital scans or impressions of your teeth. These extra steps are not part of routine treatment but are crucial for the study. The main part of the study assessing the anchorage devices will last about 9-12 months, but we will continue to follow your progress until your orthodontic treatment is completely finished to see how stable your bite correction is.

Potential risks and benefits

Taking part in this study means you will receive high-quality orthodontic treatment for your open bite. A potential benefit is that your treatment will be carefully monitored, and you will contribute to improving future patient care. Potential risks are generally low, as both treatments are standard procedures. These might include the usual, minor discomfort associated with braces and the placement of temporary anchors, which is a common procedure. You have the right to withdraw from the study at any time without your routine care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Dundee Dental Hospital
    Verified postcode
    Dundee, United Kingdom

Common questions

What is an 'anterior open bite'?

It's when your top and bottom front teeth don't touch when you bite down, leaving a gap.

What are 'TADs'?

They are small, temporary anchors, like tiny screws, placed in your mouth to help move teeth with braces.

Will I still get my regular braces treatment?

Yes, you will still receive your full orthodontic treatment with fixed braces.

How long will I be in the study?

The main part of the study measuring the anchors lasts about 9-12 months, but we'll follow you until your overall brace treatment is finished.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your ongoing dental care.

How to find out more

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

Discussion

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