Is a primer needed for orthodontic bonding? A multi-centre RCT

• Research type

  Research Study

• Full title

  Is a primer needed for orthodontic bonding? A Randomised Controlled Clinical Trial

• IRAS ID

  118693

• Contact name

  Nadine Y Houghton

• Contact email

  Nadine.Houghton@bthft.nhs.uk

• Clinicaltrials.gov Identifier

  NCT01782521

• Research summary

  Orthodontic treatment is carried out by placing fixed attachments(brackets)on teeth with wires which run through them and create tooth movement. These metal brackets are bonded (glued) onto the tooth surface as follows: Firstly,a mild acid is used to roughen the tooth surface,secondly a free flowing glue (composite primer) is used to fill in the roughened pores and thirdly, the bracket is glued on to the tooth surface with a ’composite’ material which sets hard by exposure to a high intensity light.Bracket debond will be measured per study group.
  Literature review suggests that the scientific evidence is not clear to indicate whether the use of a primer is absolutely essential to achieve acceptable bracket success rates in a clinical environment.

  The primary aim of the study is to find out if the rate of loss of orthodontic brackets is clinically acceptable when they are glued onto the tooth surface without the use of a primer as compared to brackets bonded with a primer over a 12 month study period. We will also investigate the Bonding time,Type of bracket bond failure,length of treatment,debond time and Peer Assessment Rating scores (PAR) - this index measures improvement following treatment.
  This RCT will be undertaken on consented NHS patients in 3 hospitals in Yorkshire region by multiple operators

  The results from this study will help improve our knowledge of the best approach to bonding metal brackets on teeth. If the bracket failure rate is similar in both groups, this would indicate that the use of a primer is not always necessary. For patients, this would mean lesser time required to place brackets at the start of orthodontic treatment. For clinicians and NHS purchasers the outcome will influence cost effectiveness (as the primer is the most expensive component in the bonding process) and provide a framework for future studies.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  13/YH/0345

• Date of REC Opinion

  4 Dec 2013

• REC opinion

  Further Information Favourable Opinion