Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

Oral Surgery Clinical Trial

— COOL  

Official title:

Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426515
• Other study ID #: RG_14-080
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2019
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 30, 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Surgery

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Birmingham Dental Hospital	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Birmingham Community Healthcare NHS

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Post operative pain 7 days after operation as measured in mm from VAS scale	7 days