Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Wisdom Tooth Removal
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
November 6, 2014
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 3, 2015
August 1, 2015
4 months
October 9, 2014
September 2, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Secondary Outcomes (1)
Patient satisfaction
Day 24
Study Arms (2)
Hilotherm cooling face mask
EXPERIMENTALUse of Hilotherm cooling face mask post-operatively following surgical wisdom tooth removal to evaluate the incidence of pain and swelling
No Hilotherm
NO INTERVENTIONNo intervention following surgical wisdom tooth removal (same patient), therefore the patient is their own control.
Interventions
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.
Eligibility Criteria
You may qualify if:
- any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Marys Hospital, Kings College London NHS Foundation Trust
Sidcup, Kent, DA146LT, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS
Kings College Hospital NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
November 6, 2014
Study Start
August 1, 2015
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
September 3, 2015
Record last verified: 2015-08