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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426515
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Birmingham Community Healthcare NHS
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Surgery Device: Hilotherm® cooling device and face mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryotherapy to Improve Outcomes in Lower Third Molar Surgery
Study Start Date : August 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 30, 2018

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.



Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: 7 days ]
    Post operative pain 7 days after operation as measured in mm from VAS scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426515


Locations
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United Kingdom
Birmingham Dental Hospital
Birmingham, United Kingdom, B4
Sponsors and Collaborators
University of Birmingham
Birmingham Community Healthcare NHS
Investigators
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Principal Investigator: Thomas Dietrich University of Birmingham
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02426515    
Other Study ID Numbers: RG_14-080
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019