The effectiveness of functional appliance in Class II malocclusion

• Research type

  Research Study

• Full title

  A comparison of the effectiveness of fixed versus removable functional appliances in the treatment of class II malocclusion in children: A randomized clinical trial.

• IRAS ID

  208408

• Contact name

  Ama Johal

• Sponsor organisation

  Queen Mary University of London

• ISRCTN Number

  ISRCTN11717011

• Duration of Study in the UK

  3 years, 5 months, 1 days

• Research summary

  Sticking out front teeth is a common dental feature and affects about 25% of 12 years’ children in the UK. The affected children are more likely to suffer teasing, with resultant psychological harms and distress, and may influence children’s quality of life, Furthermore, this children are more susceptible for upper front teeth injury or trauma. This problem can be corrected by seeking orthodontic treatment and wear a functional brace that works by holding the bottom jaw in a forward position, in growing children, to encourage more natural growth of the jaws. Functional braces may be classified into: either a fixed by glue onto the teeth, or a removable. Research suggests that the most popular type of removable functional appliance is called the Twin-Block, and the most popular fixed functional brace is the Herbst, and both types work effectively. However, we are not entirely sure which is more effective in correcting sticking out upper front teeth, and what would be preferable from a child’s viewpoint. Hence, the primary aims of this clinical trial are to compare the effectiveness of both appliances on morphological changes, and the treatment duration. The secondary aims are to compare their impact on children oral health and related quality of life, and cost-effectiveness. Patients who fulfil the inclusion criteria and after reading a participant information sheet, will be asked to sign an assent form and their parents a consent form. Treatment allocation will be performed centrally at Queen Mary University. The patients will be randomized to receive either a Herbst or Twin-Block appliance, based on randomisation lists. Treatment will be provided by four clinicians in a two-centre study in the UK: Bart’s Health and East Kent Hospitals Trusts. The duration of participants in the trial will be (12-36 months). This includes the length of functional treatment phase (6-12 months) followed by the second phase of train track braces treatment (12-18 months) if that is necessary to achieve an optimal teeth and bite.\n

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  16/NW/0837

• Date of REC Opinion

  6 Dec 2016

• REC opinion

  Further Information Favourable Opinion