Molar, Third Clinical Trial
Official title:
Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Lower Third Molar Removal
This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain following the surgical removal of lower wisdom teeth. All participants will have two lower wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the patients' face for 60 minutes post-operatively, thus the patient being their own control.
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 the recovery area 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
wisdom tooth removal. 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 - 60 minutes post-op after patient has worn Hilotherm cooling mask 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. Any patients with
immune system affecting diseases, and patients who suffer allergic reactions to
pharmaceutical agents will also not be considered.
No other elements of treatment will be changed from normal protocol.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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