Molar, ThirdNCT02284841
Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Wisdom Tooth Removal
A study testing Hilotherm cooling face mask in people with Molar, Third and Wisdom Teeth, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain following the surgical removal of lower wisdom teeth. All participants will have two lower wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the patients' face for 60 minutes… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar, Third, Wisdom Teeth
- What is being tested?
- Hilotherm cooling face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Jul 2016
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia
Who cannot join
- any intra-operative complications
- any post-operative complications, including infection
- if the extractions end up being too dissimilar surgically
- any contra-indication to the Hilotherm mask
- patients with any immune system-affecting diseases
- patients with allergies to pharmaceutical drugs (eg. analgesics or antibiotics)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Marys Hospital, Kings College London NHS Foundation Trust
Sidcup, Kent, DA146LT
Meera Pajpani, BDS, 447866026341, meera.pajpani@nhs.net
Kathleen Fan, MBBS BDS, 447866026341, kfan@nhs.net
About this study
Official title: Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Lower Third Molar Removal
This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain following the surgical removal of lower wisdom teeth. All participants will have two lower wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the patients' face for 60 minutes post-operatively, thus the patient being their own control.
Read the detailed description
How does Hilotherm therapy affect post-operative pain and swelling after surgical wisdom tooth removal?
Wisdom tooth removal is one of the most common minor oral surgical procedures. The most widely experienced post-operative complications include pain and swelling, and so any research into how these effects can be minimised is of utmost importance to improve the quality of care we can deliver to our patients.
Our research is investigating the efficacy of Hilotherm therapy, which uses pre-shaped plastic facial masks through which water circulates at a controlled temperature, to reduce the experience of post-operative pain and swelling.
The Hilotherm face mask will be placed immediately after the surgery, while the patient is in the recovery area and will be worn on ONE side of the face, this being randomised using a computer programme and decided at the time of surgery. It will be worn for one hour after wisdom tooth removal. We will then use 3D photography analysis of the patients face to assess the extent of swelling, their assessment of pain using a visual analogue scale, and their overall satisfaction with Hilotherm therapy. These measurements will be recorded at:
Day 0 - 60 minutes post-op after patient has worn Hilotherm cooling mask Day 3 Day 10 Day 24
The person analysing the 3D images will be blinded to the side of the intervention.
All patients undergoing wisdom tooth removal on both sides, of similar surgical difficulty, to be carried out under a General Anaesthetic of the Daycase Unit of One Hospital will be eligible. Both extractions will be carried out by the same surgeon. Participants who undergo complications during or after the procedure will be excluded from our study. Extractions which end up being too dissimilar will also be excluded, and patients unsuitable for use of the Hilotherm mask (for example allergies) will also not be considered. Any patients with immune system affecting diseases, and patients who suffer allergic reactions to pharmaceutical agents will also not be considered.
No other elements of treatment will be changed from normal protocol.
- Conditions
- Molar, Third, Wisdom Teeth
- Being tested
- Hilotherm cooling face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hilotherm cooling face maskDevice
Hilotherapy - use of an external cooling device; a facial mask through which water circulates at a controlled temperature, allowing continuous cooling of the face, and is thought to reduce post-operative swelling and pain.
| Study group | Role | What they receive |
|---|---|---|
| Hilotherm cooling face mask | Experimental | Use of Hilotherm cooling face mask post-operatively following surgical wisdom tooth removal to evaluate the incidence of pain and swelling Receives: Device: Hilotherm cooling face mask |
| No Hilotherm | No intervention | No intervention following surgical wisdom tooth removal (same patient), therefore the patient is their own control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative swelling using 3D photography analysis
Extent of swelling on the side of wisdom tooth removal with the intervention compared with the side without the intervention
Measured: Day 0 (pre/60 min post op), Days 3, 10, 24.
Change in pain intensity using visual analogue scale
Self-reported pain intensity using visual analogue scale at time intervals as above, comparing the side of wisdom tooth removal with intervention vs the side of wisdom tooth removal without intervention
Measured: Day 0 (60 min post-op), Days 3, 10, 24.
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction questionnaire to ask them to assess and compare side with intervention versus side without intervention. Did they feel it made a big difference to their post-operative pain and swelling, and to the speed with which they felt they could return to normal life (eg work?)
Measured: Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar, ThirdStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS, Principal investigator, Kings College Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284841
- Sponsor's protocol ID
- Version 1
- Status last verified
- Aug 2015
- First submitted
- 9 Oct 2014
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Lower Third Molar Removal
- ClinicalTrials.gov ID
- NCT02284841
- Acronym / sponsor ID
- Version 1
- Conditions
- Molar, Third, Wisdom Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Nov 2014 (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 evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain following the surgical removal of lower wisdom teeth. All participants will have two lower wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the patients' face for 60 minutes post-operatively, thus the patient being their own control.
Detailed description
How does Hilotherm therapy affect post-operative pain and swelling after surgical wisdom tooth removal?
Wisdom tooth removal is one of the most common minor oral surgical procedures. The most widely experienced post-operative complications include pain and swelling, and so any research into how these effects can be minimised is of utmost importance to improve the quality of care we can deliver to our patients.
Our research is investigating the efficacy of Hilotherm therapy, which uses pre-shaped plastic facial masks through which water circulates at a controlled temperature, to reduce the experience of post-operative pain and swelling.
The Hilotherm face mask will be placed immediately after the surgery, while the patient is in the recovery area and will be worn on ONE side of the face, this being randomised using a computer programme and decided at the time of surgery. It will be worn for one hour after wisdom tooth removal. We will then use 3D photography analysis of the patients face to assess the extent of swelling, their assessment of pain using a visual analogue scale, and their overall satisfaction with Hilotherm therapy. These measurements will be recorded at:
Day 0 - 60 minutes post-op after patient has worn Hilotherm cooling mask Day 3 Day 10 Day 24
The person analysing the 3D images will be blinded to the side of the intervention.
All patients undergoing wisdom tooth removal on both sides, of similar surgical difficulty, to be carried out under a General Anaesthetic of the Daycase Unit of One Hospital will be eligible. Both extractions will be carried out by the same surgeon. Participants who undergo complications during or after the procedure will be excluded from our study. Extractions which end up being too dissimilar will also be excluded, and patients unsuitable for use of the Hilotherm mask (for example allergies) will also not be considered. Any patients with immune system affecting diseases, and patients who suffer allergic reactions to pharmaceutical agents will also not be considered.
No other elements of treatment will be changed from normal protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hilotherm cooling face mask | Experimental | Device: Hilotherm cooling face maskUse of Hilotherm cooling face mask post-operatively following surgical wisdom tooth removal to evaluate the incidence of pain and swelling |
| No Hilotherm | No intervention | –No intervention following surgical wisdom tooth removal (same patient), therefore the patient is their own control. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia
Key exclusion criteria (6 listed)
- any intra-operative complications
- any post-operative complications, including infection
- if the extractions end up being too dissimilar surgically
- any contra-indication to the Hilotherm mask
- patients with any immune system-affecting diseases
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 face maskHilotherapy - use of an external cooling device; a facial mask through which water circulates at a controlled temperature, allowing continuous cooling of the face, and is thought to reduce post-operative swelling and pain. | Device | Hilotherm cooling face mask |
Primary outcome
Change in post-operative swelling using 3D photography analysis
Time frame: Day 0 (pre/60 min post op), Days 3, 10, 24.
Extent of swelling on the side of wisdom tooth removal with the intervention compared with the side without the intervention
Change in pain intensity using visual analogue scale
Time frame: Day 0 (60 min post-op), Days 3, 10, 24.
Self-reported pain intensity using visual analogue scale at time intervals as above, comparing the side of wisdom tooth removal with intervention vs the side of wisdom tooth removal without intervention
1 secondary outcome
Patient satisfaction
Time frame: Day 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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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.
Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS principal investigator
Kings College Hospital NHS Foundation Trust
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 face mask in people with Molar, Third and Wisdom Teeth, run by King's College Hospital NHS Trust 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 1 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: status not confirmed, as of the sponsor's last update on 3 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathy Fan, PhD, FDSRSC, FRCSEd, FRCS OMFS (+44 208 302 2678 ext. 4148, kfan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-operative swelling using 3D photography analysis (time frame: Day 0 (pre/60 min post op), Days 3, 10, 24.). The study lists 2 primary outcomes in all. 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 3 Sep 2015.