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

University of Birmingham

Status: Completed

Conditions: Oral Surgery

Treatments: Device: Hilotherm® cooling device and face mask

Study type: Interventional

Funder types: Other

Identifiers

NCT02426515

RG_14-080

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Hilotherm® Device

Experimental group

Description:

Patients undergo removal of lower third molar with Hilotherm® cooling device applied.

Treatment:

Device: Hilotherm® cooling device and face mask

Control

No Intervention group

Description:

Patients undergo removal of lower third molar without the Hilotherm® cooling device applied.