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Dr Nicola Mandall


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Be Part of Research - Trial Details - A clinical trial to assess the effectiveness of miniplate surgical treatment to bring the upper jaw forwards in 11-14 years old children
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A clinical trial to assess the effectiveness of miniplate surgical treatment to bring the upper jaw forwards in 11-14 years old children

Not Recruiting

Open to: All Genders

Age: Child

Lancashire

Medical Conditions

Oral and maxillofacial surgery and orthodontics

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Children with a lower jaw protruding forward of the upper jaw have what is called a class III skeletal pattern. In some cases, it is caused by the upper jaw being set too far back. The treatment in such cases is to bring the upper jaw forward to correct the reverse bite. Patients are not usually offered corrective treatment until their general and facial growth is complete at around 17-18 years of age, at which point they may be offered orthognathic (jaw) surgery to correct the position of the jaw. The surgery involves a controlled break of the upper and lower jaw from inside the mouth which are then screwed into place to hold the jaws into their new position. There is an early treatment option, for children under the age of 10 that may prevent them from having to undergo the surgery when they are older. This means wearing reverse headgear, which brings the top jaw and teeth forwards over time and has a 70% success rate, but this option only works for children under the age of 10. There is, however, another option for 11-14 year olds. This is called Bone Anchored Maxillary Protection (BAMP). It involves places small metal plates (miniplates) from inside the mouth into the front part of the cheekbone next to the upper molars on each side. Further miniplates are positioned near the front of the lower jaw. Elastics are then attached from the upper to the lower plates, via hooks, to bring the upper jaw and teeth forwards and correct the class III skeletal pattern. At the moment, BAMP is not used routinely used in the UK. Here, we want to see how well it performs compared with a no treatment (control group) to see whether it reduces the need for orthognathic surgery at a later date.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Jul 2015 01 Oct 2019

Publications

2024 Results article in https://doi.org/10.1177/14653125241255139 (added 29/10/2024)

Participants are randomly allocated into one of two groups. Those in group 1 undergo BAMP surgery. Those in group 2 are given no treatment. The success of the treatment will be assessed according to how much the upper jaw moves to correct the reverse bite and whether orthognathic surgery is needed at a later date. All participants are followed up at 1 year and 3 years after the start of the trial to compare the outcomes for each group.


Children aged between 11-14, with a class III skeletal pattern and a reverse bite.

You can take part if:



You may not be able to take part if:


1. Cleft lip and or palate or craniofacial syndrome2. Reverse bite greater than 6mm3. Lower jaw asymmetric 4. Muscular dystrophy (weakness)5. Patient smokes


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Tameside Hospital NHS Foundation Trust
    Lancashire
    OL6 9RW

Possible benefits of BAMP include avoiding orthognathic surgery at a later date. The treatment is also considerably cheaper than orthognathic surgery and is a 30 minute daycase procedure rather than a treatment requiring a 3 day stay in hospital.

Dr Nicola Mandall



The study is sponsored by Tameside Hospital NHS Foundation Trust (UK) and funded by DB Orthodontics (UK).



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Read full details for Trial ID: ISRCTN93900866
Last updated 29 October 2024

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