Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Wisdom Tooth Removal

Molar, Third Clinical Trial

Official title:

Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Lower Third Molar Removal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02284841
• Other study ID #: Version 1
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2014
• Last updated: September 2, 2015
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: King's College Hospital NHS Trust
• Contact: Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS
• Phone: +44 208 302 2678
• Email: kfan[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia

Exclusion Criteria:

• any intra-operative complications

• any post-operative complications, including infection

• if the extractions end up being too dissimilar surgically

• any contra-indication to the Hilotherm mask

• patients with any immune system-affecting diseases

• patients with allergies to pharmaceutical drugs (eg. analgesics or antibiotics)

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Molar, Third
• Pain, Postoperative
• Wisdom Teeth

Intervention

Device:
• Hilotherm cooling face mask
Hilotherapy - use of an external cooling device; a facial mask through which water circulates at a controlled temperature, allowing continuous cooling of the face, and is thought to reduce post-operative swelling and pain.

Locations

Country	Name	City	State
United Kingdom	Queen Marys Hospital, Kings College London NHS Foundation Trust	Sidcup	Kent

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-operative swelling using 3D photography analysis	Extent of swelling on the side of wisdom tooth removal with the intervention compared with the side without the intervention	Day 0 (pre/60 min post op), Days 3, 10, 24.	No
Primary	Change in pain intensity using visual analogue scale	Self-reported pain intensity using visual analogue scale at time intervals as above, comparing the side of wisdom tooth removal with intervention vs the side of wisdom tooth removal without intervention	Day 0 (60 min post-op), Days 3, 10, 24.	No
Secondary	Patient satisfaction	Patient satisfaction questionnaire to ask them to assess and compare side with intervention versus side without intervention. Did they feel it made a big difference to their post-operative pain and swelling, and to the speed with which they felt they could return to normal life (eg work?)	Day 24	No