Hilotherm therapy following surgical wisdom tooth removal Version 1.1

• Research type

  Research Study

• Full title

  Effect of Hilotherm therapy on post operative pain and swelling following surgical lower third molar removal

• IRAS ID

  164005

• Contact name

  Kathy Fan

• Contact email

  kfan@nhs.net

• Clinicaltrials.gov Identifier

  NCT02284841

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  How does Hilotherm therapy affect post-operative pain and swelling after surgical wisdom tooth removal?

  Wisdom tooth removal is one of the most common minor oral surgical procedures. The most widely experienced post-operative complications include pain and swelling, and so any research into how these effects can be minimised is of utmost importance to improve the quality of care we can deliver to our patients.

  Our research is investigating the efficacy of Hilotherm therapy, which uses pre-shaped plastic facial masks through which water circulates at a controlled temperature, to reduce the experience of post-operative pain and swelling.

  The Hilotherm face mask will be placed immediately after the surgery, while the patient is in recovery and will be worn on ONE side of the face, this being randomised using a computer programme and decided at the time of surgery. It will be worn for one hour after surgery. We will then use 3D photography analysis of the patients face to assess the extent of swelling, their assessment of pain using a visual analogue scale, and their overall satisfaction with Hilotherm therapy. These measurements will be recorded at:

  Day 0
  Day 3
  Day 10
  Day 24

  The person analysing the 3D images will be blinded to the side of the intervention.

  All patients undergoing wisdom tooth removal on both sides, of similar surgical difficulty, to be carried out under a General Anaesthetic of the Daycase Unit of One Hospital will be eligible. Both extractions will be carried out by the same surgeon. Participants who undergo complications during or after the procedure will be excluded from our study. Extractions which end up being too dissimilar will also be excluded, and patients unsuitable for use of the Hilotherm mask (for example allergies) will also not be considered.

  No other elements of treatment will be changed from normal protocol.

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  15/LO/0658

• Date of REC Opinion

  15 Jun 2015

• REC opinion

  Further Information Favourable Opinion