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

Primary Purpose

Molar, Third, Wisdom Teeth

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hilotherm cooling face mask
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Molar, Third

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Queen Marys Hospital, Kings College London NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hilotherm cooling face mask

No Hilotherm

Arm Description

Use of Hilotherm cooling face mask post-operatively following surgical wisdom tooth removal to evaluate the incidence of pain and swelling

No intervention following surgical wisdom tooth removal (same patient), therefore the patient is their own control.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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?)

Full Information

First Posted
October 9, 2014
Last Updated
September 2, 2015
Sponsor
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02284841
Brief Title
Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Wisdom Tooth Removal
Official Title
Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Lower Third Molar Removal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar, Third, Wisdom Teeth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hilotherm cooling face mask
Arm Type
Experimental
Arm Description
Use of Hilotherm cooling face mask post-operatively following surgical wisdom tooth removal to evaluate the incidence of pain and swelling
Arm Title
No Hilotherm
Arm Type
No Intervention
Arm Description
No intervention following surgical wisdom tooth removal (same patient), therefore the patient is their own control.
Intervention Type
Device
Intervention Name(s)
Hilotherm cooling face mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in post-operative swelling using 3D photography analysis
Description
Extent of swelling on the side of wisdom tooth removal with the intervention compared with the side without the intervention
Time Frame
Day 0 (pre/60 min post op), Days 3, 10, 24.
Title
Change in pain intensity using visual analogue scale
Description
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
Time Frame
Day 0 (60 min post-op), Days 3, 10, 24.
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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?)
Time Frame
Day 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS
Phone
+44 208 302 2678
Ext
4148
Email
kfan@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Meera Pajpani, BDS MJDF RCS Eng
Phone
+44 7866 026 341
Email
meera.pajpani@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS
Organizational Affiliation
Kings College Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Marys Hospital, Kings College London NHS Foundation Trust
City
Sidcup
State/Province
Kent
ZIP/Postal Code
DA146LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meera Pajpani, BDS
Phone
447866026341
Email
meera.pajpani@nhs.net
First Name & Middle Initial & Last Name & Degree
Kathleen Fan, MBBS BDS
Phone
447866026341
Email
kfan@nhs.net

12. IPD Sharing Statement

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

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