Cryotherapy to Improve Outcomes in Lower Third Molar Surgery (COOL)

This study is looking to see whether cooling the face using a special cooling device (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and discomfort patients feel after the procedure. The surgical removal of lower third molars (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this study shows that application of cold before and throughout the procedure is a simple way to reduce post-operative symptoms, it could benefit thousands of patients every year.

Study Overview

• Status: Completed
• Conditions: Oral Surgery
• Intervention / Treatment: Device: Hilotherm® cooling device and face mask

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B4
    • Birmingham Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth
2. Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth
3. Written informed consent

Exclusion Criteria:

1. Patients refusing to give written informed consent
2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
3. Pregnant women
4. Patients taking long-term anti-microbial or anti-inflammatory drugs
5. Patients requiring pre-operative antibiotics for surgery
6. Patients requiring concomitant extractions or contralateral lower 3rd molar removal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hilotherm® Device; Patients undergo removal of lower third molar with Hilotherm® cooling device applied.	Device: Hilotherm® cooling device and face mask; Hilotherm® is an external cooling device and facial mask through which water circulates at a controlled temperature This allows continuous cooling of the face, and is thought to reduce post-operative swelling and pain.
No Intervention: Control; Patients undergo removal of lower third molar without the Hilotherm® cooling device applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Post operative pain 7 days after operation as measured in mm from VAS scale	7 days

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Birmingham Community Healthcare NHS

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RG_14-080