Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

Not Applicable

Completed

• Conditions: Oral Surgery
• Interventions: Device: Hilotherm® cooling device and face mask

• Registration Number: NCT02426515
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-27
• Study Start: 2015-08
• Primary Completion: 2017-01
• Study Completion: 2018-06-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hilotherm® Device	Hilotherm® cooling device and face mask	Patients undergo removal of lower third molar with Hilotherm® cooling device applied.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	7 days	Post operative pain 7 days after operation as measured in mm from VAS scale

Trial Locations

Locations (1)

Birmingham Dental Hospital; 🇬🇧 Birmingham, United Kingdom