Oral SurgeryCOOLNCT02426515
Cryotherapy to Improve Outcomes in Lower Third Molar Surgery
A study testing Hilotherm® cooling device and face mask in people with Oral Surgery, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Surgery
- What is being tested?
- Hilotherm® cooling device and face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Hilotherm® cooling device and face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hilotherm® cooling device and face maskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hilotherm® Device | Experimental | Patients undergo removal of lower third molar with Hilotherm® cooling device applied. Receives: Device: Hilotherm® cooling device and face mask |
| Control | No intervention | Patients undergo removal of lower third molar without the Hilotherm® cooling device applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post operative pain 7 days after operation as measured in mm from VAS scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Community Healthcare NHS
- Responsible party
- Sponsor
- Investigators
- Thomas Dietrich, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426515
- Sponsor's protocol ID
- RG_14-080
- Acronym
- COOL
- Status last verified
- Mar 2019
- First submitted
- 17 Apr 2015
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy to Improve Outcomes in Lower Third Molar Surgery
- ClinicalTrials.gov ID
- NCT02426515
- Acronym / sponsor ID
- COOL / RG_14-080
- Conditions
- Oral Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Birmingham Community Healthcare NHS
- Study start
- Aug 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hilotherm® Device | Experimental | Device: Hilotherm® cooling device and face maskPatients undergo removal of lower third molar with Hilotherm® cooling device applied. |
| Control | No intervention | –Patients undergo removal of lower third molar without the Hilotherm® cooling device applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hilotherm® cooling device and face maskHilotherm® 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. | Device | Hilotherm® Device |
Primary outcome
Post-operative pain
Time frame: 7 days
Post operative pain 7 days after operation as measured in mm from VAS scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Dietrich principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hilotherm® cooling device and face mask in people with Oral Surgery, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.