Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Dental Hospital

Birmingham, B4, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hilotherm® cooling device and face mask

Device

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.

Primary outcomes

Post-operative pain

Time frame: 7 days

Post operative pain 7 days after operation as measured in mm from VAS scale

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

Birmingham Community Healthcare NHS

Registry information

Acronym: COOL

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Apr 27, 2015
Registry last updated: Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed