RCT to compare two functional appliances for class II malocclusions1.7

• Research type

  Research Study

• Full title

  Effectiveness of treatment for class II malocclusions with the Button & Bead or Twin-block functional appliance: A single centre randomised clinical trial

• IRAS ID

  219179

• Contact name

  Thomas Dietrich

• Contact email

  t.dietrich@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  A class II malocclusion describes a situation in which the upper teeth are further forward than the lower teeth when biting down. This influences the overjet of a patient, which is measured in millimetres and describes the distance between the upper incisor teeth and the lower incisor teeth in the anterior-posterior plane.
  An increased overjet has been reported to negatively impact the quality of life of children and their parents and is linked with an increased incidence of bullying. There is evidence to suggest individuals with unattractive occlusal traits can attract unfavourable social responses in becoming targets for nicknames, harassment and teasing from other school children. Recent evidence has suggested that an increased overjet may double or even triple the risk of traumatic dental injuries to the upper incisor teeth.

  A functional appliance is a type of orthodontic brace used to correct a Class II malocclusion in growing children. The primary aim of this study is to compare two functional appliances: the modified Clark's Twin Block and Button and Bead appliances in rate of overjet reduction.

  The patients will be recruited through referrals to the orthodontic department at Birmingham Dental Hospital. Treatment will be conducted on the orthodontic department at Birmingham Dental Hospital.
  Participants will be eligible for the study if they meet the inclusion critera and informed consent is obtained from the parent and child.

  All patients will be invited to participate in the study and provided with a participant information sheet and a parent information sheet. After initial recording of the baseline data, patients will be randomised into two groups:
  1. Twin-block group
  2. Button & Bead group

  Data will be collected at the stage of trial registration, at the point the overjet is reduced and at the end of fixed appliance treatment.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  17/WM/0158

• Date of REC Opinion

  9 Jun 2017

• REC opinion

  Further Information Favourable Opinion