Chewing gum and orthodontic pain relief

• Research type

  Research Study

• Full title

  Chewing gum and orthodontic pain relief

• IRAS ID

  6217

• Contact name

  Anthony J Ireland

• Sponsor organisation

  Royal United Hospitals NHS Trust

• Eudract number

  2008-005522-36

• Research summary

  Objectives:This project aims to determine whether chewing gum will eliminate or reduce the need for analgesia to relieve orthodontic pain, after the initial fitting or subsequent adjustment of orthodontic fixed braces. A randomised controlled trial will objectively test this hypothesis.Background: It is well recognised that one of the most frequent side effects of orthodontic treatment with braces is pain. This usually begins 2 to 3 hours after the fitting or adjustment of the brace, peaking at 2 to 3 days but sometimes lasting up to 7 days. To date, pain relief is usually achieved through the use of analgesics. There is some indication, largely through anecdotal evidence, that chewing gum may provide some pain relief and eliminate or reduce the need for analgesia.Setting and Methodology:The investigation will comprise a multicentre prospective randomised controlled clinical trial involving nine hospital orthodontic departments within the South West Region. Approximately 1000 consecutive patients aged between 12 and 16 years, who will be having upper and lower fixed appliances fitted, will be recruited into the study. Half will be provided with ibuprofen for pain relief and half with sugar free chewing gum. Pain experience and the effectiveness of the interventions will be measured in each group using a pain questionnaire over two 3 day periods, namely following brace fitting and again after the first brace adjustment. In addition to pain, the secondary outcome measures will be anxiety after fitting/ adjustment and brace breakages. Anticipated OutcomesIt is anticipated that chewing gum will reduce the need for, or eliminate the use of analgesics following the fitting or adjustment of orthodontic fixed appliances. That anxiety will affect the perception of pain, but that chewing gum use will not have any affect on the overall failure rate of the fixed braces.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  08/H0106/139

• Date of REC Opinion

  1 Dec 2008

• REC opinion

  Further Information Favourable Opinion