Extrait

Background and study aims Sticking out top front teeth is a very common problem amongst children in the UK, and is caused by incorrect alignment of the top and bottom jaws (malocclusion). This can result in more injuries to these teeth as a result of accidents. It has also been shown that a child’s confidence and the smile can be really affected by this appearance. The alignment of the jaws and the self-esteem of affected children can be improved using a functional appliance, which is a special type of brace that works by holding the bottom jaw in a forward position, to encourage more natural growth of the jaws. Functional braces may be either fixed by glue onto the teeth, or removable. The most popular type of removable functional appliance is called the Twin-Block, and the most popular fixed type is the Herbst. The aim of this study is to compare the effectiveness of fixed and removable functional braces for the treatment of children with sticking out top front teeth. Who can participate? Children aged 10-14 with sticking out top front teeth (class II malocclusion) What does the study involve? At the first visit, as in routine practice, the following procedures are undertaken: mouldings of the child’s teeth and bite using a putty material, an X-ray of the child’s jaws and teeth to check teeth development and jaw alignment, and photographs to assess the child’s teeth and face. Taking part in the study also involves the following two additional tasks: children are asked to fill in a questionnaire booklet to help better understand how the bite/appearance has affected their confidence and quality of life, and they undergo a three-dimensional facial scan, similar to a photograph, to assess the jaw line. At the second visit, the child has further moulds taken to make the functional brace. At the third visit, participants are randomly allocated to be treated with one of two braces: the fixed Herbst brace or the Twin Block brace. The Herbst brace is glued to the teeth and is not possible to take out, whereas the Twin Block is removable, and the child is advised to wear it 24 hours a day (except during swimming and contact sport). The children are then seen every 4-6 weeks (as in normal brace treatment) to check the brace, measure the amount of correction in the top teeth sticking out, and to record their experiences and compliance with the treatment. The treatment with the functional brace ends when the bite is fully corrected and the top teeth no longer stick out. This may take 6-12 months. At this point, and directly after removing the functional brace, we ask the child to complete the questionnaires and undergo a facial scan again. In addition, in line with routine functional brace care, an x-ray is taken. As with all children receiving functional braces, the child is then assessed to see if they would benefit from having train-track fixed braces. This treatment can last a further 12-18 months depending on the bite and how crooked the teeth are. If the child does not require train track braces, their treatment ends after the functional brace. If the child has the train track brace, he/she completes the questionnaires, facial scan and x-ray again when this treatment is completed. What are the possible benefits and risks of participating? The child’s sticking out front teeth and bite problem will be treated by experienced orthodontists. The information we get from this study will help improve the future treatment of children with similar problems. There are no expected risks to the child for taking part in this study. We routinely provide children these braces and follow-up care detailed above. There is a possibility that this treatment, like all brace treatment, may cause some discomfort and side effects, e.g. breakage, loss of the brace, and mouth sores or ulcers due to brace rubbing. The child will be given all the care instructions to help avoid any of these problems when the brace is fitted. Where is the study run from? 1. Barts and the London Health Trust (UK) 2. East Kent Hospitals University NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? October 2016 to April 2019 Who is funding the study? 1. Queen Mary University of London (UK) 2. Barts Health NHS Trust (UK) Who is the main contact? Dr Moaiyad Moussa Pacha [email protected]

Critère d'inclusion

• CLASS II DIVISION 1 MALOCCLUSION

Liens

• ictrp
• isrctn