Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

NCT02426515 | Completed

• 1 other identifier: RG_14-080
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Surgery

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Post operative pain 7 days after operation as measured in mm from VAS scale

  7 days

Study Arms (2)

Hilotherm® Device

EXPERIMENTAL

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

Device: Hilotherm® cooling device and face mask

Control

NO INTERVENTION

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

Interventions

Hilotherm® cooling device and face mask DEVICE

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.

Hilotherm® Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth
• Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth
• Written informed consent

You may not qualify if:

• Patients refusing to give written informed consent
• Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
• Pregnant women
• Patients taking long-term anti-microbial or anti-inflammatory drugs
• Patients requiring pre-operative antibiotics for surgery
• Patients requiring concomitant extractions or contralateral lower 3rd molar removal

Sponsors & Collaborators

• University of Birmingham: lead
• Birmingham Community Healthcare NHS: collaborator

Study Sites (1)

Birmingham Dental Hospital

Birmingham, B4, United Kingdom

Location

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Thomas Dietrich

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 27, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: June 30, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

GB (1)