Oral Surgery
Conditions
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.
Interventions
DEVICEHilotherm® 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.
Sponsors
Birmingham Community Healthcare NHS
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 7 days | Post operative pain 7 days after operation as measured in mm from VAS scale |
Countries
United Kingdom
Outcome results
None listed