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Pain associated with Interproximal Enamel Reduction : a RCT

  • Research type

    Research Study

  • Full title

    A Prospective Randomised Controlled Clinical Trial comparing Pain Experience using Manual and Rotary Interproximal Enamel Reduction Techniques

  • IRAS ID

    180832

  • Contact name

    Gursharan Minhas

  • Contact email

    gursharanminhas@nhs.net

  • Sponsor organisation

    Research, Development and Innovations

  • Clinicaltrials.gov Identifier

    NCT02455700

  • Duration of Study in the UK

    0 years, 11 months, 30 days

  • Research summary

    Interproximal enamel reduction is a technique used in orthodontics which is proven by evidence- based research to be predictable and safe and it is a technique routinely utilised in orthodontics since 1944.It is used to gain space to correct the position of crooked teeth and to help the teeth meet with eachother between the upper and lower jaws. There are two ways in which the enamel reduction can be achieved- one of these is through using a motor driven device and the other is by using a hand driven filing device.
    Both treatments are currently available at the Trust for use. Both are safe to use and the choice of technique varies with operator preference as well as which equipment is available when the procedure is being carried out.
    To date there is no data on which technique patients prefer or find more comfortable.

    This is a prospective randomized controlled clinical trial with two treatment arms comparing rotary machine driven and hand driven filing to reduce the amount of enamel between the contact points of the lower front teeth with respect to pain experienced whilst carrying out the two procedures.
    Each subject entered into the trial will have both procedures carried out on one occasion each with a 6 week washout period between procedures.
    Each subject will be asked to fill a simple questionnaire immediately before and immediately after the enamel reduction has been carried out- this is to collect data on baseline pain scores and pain scores related to the procedure.
    This data will then be analysed and assessed to determine if patients find one technique more painful than the other.
    This will add to the evidence base in orthodontics and more importantly the involvement of patients in research will enable orthodontists to give further information at the consent stage of treatment.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    15/SC/0655

  • Date of REC Opinion

    3 Nov 2015

  • REC opinion

    Further Information Favourable Opinion