Effectiveness of interdental toothbrushes in patients with fixed brace

• Research type

  Research Study

• Full title

  A randomised controlled clinical trial to determine if the use of the interdental/interspace toothbrushes in addition to the standard toothbrush is required to maintain clean teeth in patients with fixed braces

• IRAS ID

  160413

• Contact name

  Hock H Goh

• Contact email

  h.goh@nhs.net

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  1 years, 9 months, 1 days

• Research summary

  Background

  Accumulation of plaque on tooth surfaces that have fixed orthodontic appliances is increased. Effective removal is essential to maintain oral health but it is unclear whether the use of interdental or interspace brushes is useful.
  

  Objectives
  
  To compare the effectiveness of standard toothbrushes with combined standard toothbrushes and interdental/interspace brushes used by patients during fixed orthodontic appliances therapy in relation to plaque removal, the health of dental and supporting tissues, dependability, cost and adverse effects.

  Materials and Methods

  This will be a 56-week single blind, stratified; parallel group randomised controlled clinical trial. This will be a pseudo-longitudinal trial where observations are recorded at certain fixed intervals. The CONSORT guidelines for reporting randomised control trials will be followed. Examinations will be conducted at baseline, 8, 32 and 56 weeks.
  Ethical approval will be obtained appropriately prior to the commencement of the trial. Subjects will be recruited from all patients taken off the waiting list for fixed appliance treatment. They will be allowed to withdraw freely at any time.
  In order to ensure conformity, the patients will be provided with a standard toothbrush, toothpaste and those requiring it, standard interdental/interspace brush. The inclusion criteria for the subjects, gold standard, intervention, and outcome measures are set below.

  The intervention
  Patients will be shown how to get around the brackets and wires with a model with a standard toothbrush and the interdental/interspace brush by the same dental nurse. However, they will only be required to use the interdental/interspace brush once a day, last thing at night, as this appears to be the standard instruction given by most of the schools of hygiene. This will last an additional two minutes and will be timed. The rest of instructions will be the same as those for patients using the standard toothbrush.

  The outcome - Oral hygiene measures

  Gingivitis
  Gingivitis will be measured on the buccal surfaces of the teeth with the gingival index using a CPITN probe.

  Gingival bleeding
  Gingival bleeding will be determined using the Eastman interdental bleeding index

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  14/NE/1138

• Date of REC Opinion

  14 Oct 2014

• REC opinion

  Further Information Favourable Opinion